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Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer

Primary Purpose

Bladder Urothelial Carcinoma In Situ, Invasive Bladder Mixed Carcinoma, Stage 0a Bladder Cancer AJCC v8

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Gemcitabine Hydrochloride
Pembrolizumab
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Urothelial Carcinoma In Situ

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • High grade Ta, T1 or CIS urothelial carcinoma. Accrual of patients with Ta or T1 disease may be closed to ensure adequate patients enrollment to meet the primary endpoint
  • Persistent disease (defined as not achieving disease free status) after completing therapy with at least induction BCG (>= 5 doses) and the first round of maintenance or second induction course (>= 2 doses). The subsequent round of BCG, either maintenance or repeat induction, must be given within 6 months of initial induction BCG.

  • Persistent high risk NMIBC (T1, high grade Ta and/or CIS) must be within 9 months of the last BCG instillation despite having received adequate BCG as defined above.

    • Registration must be within 12 months of last BCG instillation

  • High grade T1 after completing therapy with at least induction BCG (>= 5 doses) or after completing therapy with at least induction BCG (>= 5 doses) and first round of maintenance or second induction course (>= 2 doses). The subsequent round of BCG, either maintenance or repeat induction, must be given within 6 months of initial induction BCG

    • Disease recurrence (T1) must be within 9 months of the last BCG instillation despite having received adequate BCG as defined above
    • Registration must be within 12 months of last BCG instillation

  • Patients who are disease free at 6 months after starting BCG but have high grade recurrence (T1, Ta, CIS) while on maintenance therapy would be eligible

    • The recurrence must be within 6 months of the last BCG dose.
    • Registration must be within 12 months of last maintenance BCG instillation
  • Patients must be deemed unfit for radical cystectomy by the treating physician or refuse radical cystectomy
  • All patients must have histologically confirmed urothelial cancer of the bladder within 60 days prior to registration

  • All visible tumor must be completely resected 60 days prior to registration (residual pure CIS is permitted)

    • All patients must have had a cystoscopy (or transurethral resection of bladder tumor [TURBT] with complete resection) without papillary tumor and negative urinary cytology within 28 days of registration. (positive cytology is allowed in patients with CIS)
  • All patients with T1 tumors must undergo a re-staging TURBT within 60 days of registration. There must be uninvolved muscularis propria present in the re-staging TURBT. The initial TURBT prior to re-staging TURBT may be greater than 60 days prior to registration
  • Patients must have had imaging with computed tomography (CT) or magnetic resonance imaging (MRI) abdomen/pelvis within 90 days of registration demonstrating no evidence of metastasis.

  • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects

    • Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Include as applicable: Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom)
    • A woman of childbearing potential (WOCBP) must not have a positive urine pregnancy test within 7 days prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
    • Patients must not be pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with registration through the last dose of treatment
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Hemoglobin >= 9.0 g/dL

  • Creatinine =< 1.5 x upper limit of normal (ULN)

    • In patients with creatinine > 1.5 x ULN, if measured or calculated creatinine clearance > 30 mL/min, then patient is eligible

  • Total bilirubin =< 1.5 x ULN

    • In patients with a total bilirubin > 1.5 x ULN, if direct bilirubin < 1.0 X ULN, then patient is eligible
  • Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =< 2.5 x ULN

  • Patients with human immunodeficiency virus (HIV) are eligible with the following:

    • On effective anti-retroviral therapy with undetectable viral load within 6 months of registration

Exclusion Criteria:

  • Mixed variant histology (adenocarcinoma, squamous cell carcinoma) is eligible, but pure variant histology is ineligible.
  • Patients cannot have had a history of urothelial carcinoma in the ureters or prostatic urethra 24 months prior to registration

  • Patients must not be currently participating in or have participated in a study of an investigational agent or have used an investigational device within 4 weeks prior to study registration

    • Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been more than 4 weeks after the last dose of the previous investigational agent at time of registration
  • Patients must not have prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137)
  • Patients must not have undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years prior to registration. (Participants who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of graft versus host disease [GVHD])

  • Patients must not have received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment

    • Note: Participants must have recovered from all adverse events (AEs) due to previous therapies to =< grade 1 or baseline. Participants with =< grade 2 neuropathy may be eligible
    • Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
  • Patients must not have received prior radiotherapy within 2 weeks of study registration. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
  • Patients must not have received radiation therapy to the lung that is > 30 Gy within 6 months prior to trial registration
  • Patients must not have had an active autoimmune disease requiring systemic treatment within 24 months prior to registration. Autoimmune diseases include, but not limited to, lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis

  • Patients must not have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration

    • Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
  • Patients must not have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
  • Patients must not have active tuberculosis
  • Patients must not have been treated with antibiotics for an active infection within 14 days prior to registration. Prophylactic antibiotics are permitted. Treatment for a urinary tract infection (UTI) is allowed but must be deemed adequately treated by the treating physician prior the start of cycle 1 (C1) day 1 (D1)
  • Patients must not have a history of idiopathic pulmonary fibrosis or organizing pneumonia
  • Patients must not have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis
  • HIV-infected participants must not have a history of Kaposi sarcoma and/or multicentric Castleman disease
  • Patients must not have a known additional malignancy that has had progression or has required active treatment in the last three years. Exceptions include basal or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. A history of prostate cancer that was treated with definitive intent is allowed, provided that the prostate-specific antigen (PSA) is undetectable for at least 1 year while off androgen deprivation therapy
  • Patients must not have known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment
  • Patients must not have severe hypersensitivity (>= grade 3) to pembrolizumab and/or any of its excipients
  • Patients must not have an active infection requiring systemic therapy

  • Patients must not have a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected) infection

    • Note: No testing for hepatitis B and hepatitis C is required unless mandated by a local health authority
  • Patients must not have received live vaccines within 30 days of study drug administration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed. COVID-19 vaccinations are permitted.

  • Physicians should consider whether any of the following may render the patient inappropriate for this protocol:

    • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator

Sites / Locations

  • University of Alabama at Birmingham Cancer CenterRecruiting
  • Anchorage Associates in Radiation Medicine
  • Anchorage Radiation Therapy Center
  • Alaska Breast Care and Surgery LLC
  • Alaska Oncology and Hematology LLC
  • Alaska Women's Cancer Care
  • Anchorage Oncology Centre
  • Katmai Oncology Group
  • Providence Alaska Medical Center
  • Fairbanks Memorial HospitalRecruiting
  • Cancer Center at Saint Joseph'sRecruiting
  • Mayo Clinic Hospital in ArizonaRecruiting
  • Mayo Clinic in ArizonaRecruiting
  • Mercy Hospital Fort Smith
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
  • Cedars Sinai Medical Center
  • University of California Davis Comprehensive Cancer CenterRecruiting
  • Rocky Mountain Cancer Centers-AuroraRecruiting
  • The Medical Center of Aurora
  • Boulder Community Hospital
  • Boulder Community Foothills Hospital
  • Rocky Mountain Cancer Centers-BoulderRecruiting
  • Rocky Mountain Cancer Centers - CentennialRecruiting
  • Cancer Center of Colorado at Sloan's Lake
  • National Jewish Health-Main Campus
  • The Women's Imaging Center
  • Colorado Blood Cancer Institute
  • Presbyterian - Saint Lukes Medical Center - Health One
  • Rocky Mountain Cancer Centers-MidtownRecruiting
  • SCL Health Saint Joseph Hospital
  • Rocky Mountain Cancer Centers-RoseRecruiting
  • Rose Medical Center
  • Western Surgical Care
  • Mountain Blue Cancer Care Center - Swedish
  • Rocky Mountain Cancer Centers - Swedish
  • Swedish Medical Center
  • The Melanoma and Skin Cancer Institute
  • National Jewish Health-Western Hematology Oncology
  • Saint Mary's Hospital and Regional Medical Center
  • North Colorado Medical Center
  • Good Samaritan Medical Center
  • Rocky Mountain Cancer Centers-Lakewood
  • Rocky Mountain Cancer Centers-LittletonRecruiting
  • Rocky Mountain Cancer Centers-Sky RidgeRecruiting
  • Sky Ridge Medical Center
  • McKee Medical Center
  • National Jewish Health-Northern Hematology Oncology
  • Rocky Mountain Cancer Centers-Thornton
  • SCL Health Lutheran Medical Center
  • MedStar Georgetown University HospitalRecruiting
  • MedStar Washington Hospital CenterRecruiting
  • Holy Cross Hospital
  • University of Florida Health Science Center - GainesvilleRecruiting
  • Hawaii Cancer Care - WestridgeRecruiting
  • Pali Momi Medical CenterRecruiting
  • Queen's Cancer Center - Pearlridge
  • The Cancer Center of Hawaii-Pali Momi
  • The Queen's Medical Center - West Oahu
  • Hawaii Cancer Care Inc - Waterfront PlazaRecruiting
  • Island Urology
  • Queen's Cancer Cenrer - POB I
  • Queen's Medical Center
  • Straub Clinic and HospitalRecruiting
  • University of Hawaii Cancer Center
  • Hawaii Cancer Care Inc-Liliha
  • Hawaii Diagnostic Radiology Services LLC
  • Kuakini Medical Center
  • Queen's Cancer Center - Kuakini
  • The Cancer Center of Hawaii-Liliha
  • Kapiolani Medical Center for Women and Children
  • Straub Medical Center - Kahului Clinic
  • Castle Medical Center
  • Wilcox Memorial Hospital and Kauai Medical Clinic
  • Saint Alphonsus Cancer Care Center-BoiseRecruiting
  • Saint Luke's Cancer Institute - Boise
  • Saint Alphonsus Cancer Care Center-CaldwellRecruiting
  • Kootenai Health - Coeur d'AleneRecruiting
  • Walter Knox Memorial Hospital
  • Saint Luke's Cancer Institute - Fruitland
  • Idaho Urologic Institute-Meridian
  • Saint Luke's Cancer Institute - Meridian
  • Saint Luke's Cancer Institute - Nampa
  • Saint Alphonsus Cancer Care Center-NampaRecruiting
  • Kootenai Clinic Cancer Services - Post FallsRecruiting
  • Kootenai Cancer ClinicRecruiting
  • Saint Luke's Cancer Institute - Twin Falls
  • Saint Anthony's Health
  • Illinois CancerCare-Bloomington
  • Illinois CancerCare-Canton
  • Memorial Hospital of Carbondale
  • SIH Cancer Institute
  • Illinois CancerCare-Carthage
  • Centralia Oncology Clinic
  • Rush University Medical Center
  • Cancer Care Specialists of Illinois - DecaturRecruiting
  • Decatur Memorial Hospital
  • Illinois CancerCare-Dixon
  • Crossroads Cancer CenterRecruiting
  • Illinois CancerCare-Eureka
  • Illinois CancerCare-Galesburg
  • Western Illinois Cancer Treatment Center
  • Illinois CancerCare-Kewanee Clinic
  • Illinois CancerCare-Macomb
  • Loyola University Medical CenterRecruiting
  • Marjorie Weinberg Cancer Center at Loyola-Gottlieb
  • Good Samaritan Regional Health Center
  • Cancer Care Center of O'FallonRecruiting
  • Illinois CancerCare-Ottawa Clinic
  • Illinois CancerCare-Pekin
  • Illinois CancerCare-Peoria
  • Methodist Medical Center of Illinois
  • Illinois CancerCare-Peru
  • Valley Radiation Oncology
  • Illinois CancerCare-Princeton
  • Southern Illinois University School of MedicineRecruiting
  • Springfield ClinicRecruiting
  • Memorial Medical CenterRecruiting
  • Southwest Illinois Health Services LLP
  • Illinois CancerCare - Washington
  • Reid Health
  • Memorial Hospital of South BendRecruiting
  • Central Care Cancer Center - Garden City
  • Central Care Cancer Center - Great Bend
  • University of Kansas Cancer CenterRecruiting
  • University of Kansas Hospital-Westwood Cancer CenterRecruiting
  • University of Kentucky/Markey Cancer Center
  • East Jefferson General HospitalRecruiting
  • LSU Healthcare Network / Metairie Multi-Specialty ClinicRecruiting
  • Louisiana State University Health Science Center
  • UM Baltimore Washington Medical Center/Tate Cancer CenterRecruiting
  • Lowell General Hospital
  • Mercy Medical Center
  • Hickman Cancer Center
  • Saint Joseph Mercy HospitalRecruiting
  • Bronson Battle CreekRecruiting
  • Saint Joseph Mercy BrightonRecruiting
  • Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
  • Saint Joseph Mercy CantonRecruiting
  • Trinity Health IHA Medical Group Hematology Oncology - CantonRecruiting
  • Caro Cancer Center
  • Saint Joseph Mercy ChelseaRecruiting
  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalRecruiting
  • Hematology Oncology Consultants-Clarkston
  • Newland Medical Associates-Clarkston
  • Ascension Saint John HospitalRecruiting
  • Great Lakes Cancer Management Specialists-Doctors ParkRecruiting
  • Genesee Cancer and Blood Disease Treatment CenterRecruiting
  • Genesee Hematology Oncology PCRecruiting
  • Genesys Hurley Cancer InstituteRecruiting
  • Hurley Medical CenterRecruiting
  • Helen DeVos Children's Hospital at Spectrum Health
  • Spectrum Health at Butterworth CampusRecruiting
  • Trinity Health Grand Rapids Hospital
  • Academic Hematology Oncology SpecialistsRecruiting
  • Great Lakes Cancer Management Specialists-Van Elslander Cancer CenterRecruiting
  • Michigan Breast Specialists-Grosse Pointe Woods
  • Bronson Methodist HospitalRecruiting
  • West Michigan Cancer CenterRecruiting
  • Ascension Borgess Cancer CenterRecruiting
  • Borgess Medical Center
  • Sparrow HospitalRecruiting
  • Hope Cancer Clinic
  • Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
  • Great Lakes Cancer Management Specialists-Macomb Medical CampusRecruiting
  • Michigan Breast Specialists-Macomb Township
  • Saint Mary's Oncology/Hematology Associates of Marlette
  • Toledo Clinic Cancer Centers-Monroe
  • Trinity Health Muskegon HospitalRecruiting
  • Lakeland Hospital Niles
  • Cancer and Hematology Centers of Western Michigan - Norton ShoresRecruiting
  • 21st Century Oncology-Pontiac
  • Hope Cancer Center
  • Newland Medical Associates-Pontiac
  • Saint Joseph Mercy Oakland
  • Spectrum Health Reed City Hospital
  • Great Lakes Cancer Management Specialists-Rochester Hills
  • Ascension Saint Mary's HospitalRecruiting
  • Oncology Hematology Associates of Saginaw Valley PCRecruiting
  • Lakeland Medical Center Saint Joseph
  • Marie Yeager Cancer CenterRecruiting
  • Bhadresh Nayak MD PC-Sterling HeightsRecruiting
  • Ascension Saint Joseph HospitalRecruiting
  • Munson Medical CenterRecruiting
  • Advanced Breast Care Center PLLC
  • Great Lakes Cancer Management Specialists-Macomb Professional BuildingRecruiting
  • Macomb Hematology Oncology PC
  • Michigan Breast Specialists-Warren
  • Saint John Macomb-Oakland HospitalRecruiting
  • Saint Mary's Oncology/Hematology Associates of West Branch
  • University of Michigan Health - WestRecruiting
  • Huron Gastroenterology PCRecruiting
  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
  • Fairview Ridges Hospital
  • Minnesota Oncology - Burnsville
  • Cambridge Medical Center
  • Mercy Hospital
  • Fairview Southdale Hospital
  • Unity Hospital
  • Fairview Clinics and Surgery Center Maple Grove
  • Minnesota Oncology Hematology PA-Maplewood
  • Saint John's Hospital - Healtheast
  • Abbott-Northwestern Hospital
  • Hennepin County Medical Center
  • Health Partners Inc
  • Monticello Cancer Center
  • New Ulm Medical Center
  • Fairview Northland Medical Center
  • North Memorial Medical Health Center
  • Park Nicollet Clinic - Saint Louis Park
  • Regions Hospital
  • United Hospital
  • Saint Francis Regional Medical Center
  • Lakeview Hospital
  • Ridgeview Medical Center
  • Rice Memorial Hospital
  • Minnesota Oncology Hematology PA-Woodbury
  • Fairview Lakes Medical Center
  • Saint Louis Cancer and Breast Institute-Ballwin
  • Central Care Cancer Center - Bolivar
  • Cox Cancer Center Branson
  • Saint Francis Medical CenterRecruiting
  • Southeast Cancer Center
  • Saint Luke's HospitalRecruiting
  • MU Health - University Hospital/Ellis Fischel Cancer CenterRecruiting
  • Parkland Health Center - FarmingtonRecruiting
  • Capital Region Southwest Campus
  • Freeman Health System
  • Mercy Hospital Joplin
  • Delbert Day Cancer Institute at PCRMC
  • Mercy Clinic-Rolla-Cancer and Hematology
  • Heartland Regional Medical Center
  • Saint Louis Cancer and Breast Institute-South City
  • Mercy Hospital South
  • Missouri Baptist Medical CenterRecruiting
  • Mercy Hospital Saint LouisRecruiting
  • Sainte Genevieve County Memorial HospitalRecruiting
  • Mercy Hospital Springfield
  • CoxHealth South Hospital
  • Missouri Baptist Sullivan HospitalRecruiting
  • Missouri Baptist Outpatient Center-Sunset HillsRecruiting
  • Mercy Hospital Washington
  • Community Hospital of AnacondaRecruiting
  • Billings Clinic Cancer CenterRecruiting
  • Saint Vincent Healthcare
  • Saint Vincent Frontier Cancer Center
  • Bozeman Deaconess HospitalRecruiting
  • Saint James Community Hospital and Cancer Treatment Center
  • Benefis Healthcare- Sletten Cancer InstituteRecruiting
  • Great Falls Clinic
  • Kalispell Regional Medical CenterRecruiting
  • Saint Patrick Hospital - Community Hospital
  • Community Medical HospitalRecruiting
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
  • Memorial Sloan Kettering Basking RidgeRecruiting
  • Hackensack University Medical Center
  • Memorial Sloan Kettering MonmouthRecruiting
  • Memorial Sloan Kettering BergenRecruiting
  • The Valley Hospital-Luckow Pavilion
  • Neurosurgeons of New Jersey-Ridgewood
  • Valley Hospital
  • Valley Health System-Hematology/Oncology
  • Memorial Sloan Kettering CommackRecruiting
  • Arnot Ogden Medical Center/Falck Cancer CenterRecruiting
  • The New York Hospital Medical Center of Queens
  • Memorial Sloan Kettering WestchesterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • NYP/Weill Cornell Medical CenterRecruiting
  • Stony Brook University Medical CenterRecruiting
  • Memorial Sloan Kettering NassauRecruiting
  • UNC Lineberger Comprehensive Cancer CenterRecruiting
  • University of North Carolina-Hillsborough CampusRecruiting
  • Indu and Raj Soin Medical Center
  • Saint Elizabeth Boardman Hospital
  • Dayton Physicians LLC-Miami Valley South
  • Miami Valley Hospital South
  • Oncology Hematology Care Inc-Kenwood
  • Miami Valley Hospital
  • Dayton Physician LLC-Miami Valley Hospital North
  • Miami Valley Hospital North
  • Armes Family Cancer Center
  • Blanchard Valley Hospital
  • Orion Cancer Care
  • Atrium Medical Center-Middletown Regional Hospital
  • Dayton Physicians LLC-Atrium
  • Dayton Physicians LLC-Wayne
  • Wayne Hospital
  • Greater Dayton Cancer Center
  • First Dayton Cancer Care
  • Kettering Medical Center
  • Mercy Health Perrysburg Cancer Center
  • Springfield Regional Cancer Center
  • Springfield Regional Medical Center
  • Mercy Health - Saint Anne Hospital
  • Toledo Clinic Cancer Centers-ToledoRecruiting
  • Dayton Physicians LLC - Troy
  • Upper Valley Medical Center
  • Saint Joseph Warren Hospital
  • Saint Elizabeth Youngstown Hospital
  • University of Oklahoma Health Sciences CenterRecruiting
  • Mercy Hospital Oklahoma City
  • Saint Alphonsus Medical Center-Baker City
  • Saint Charles Health System
  • Clackamas Radiation Oncology Center
  • Providence Cancer Institute Clackamas Clinic
  • Bay Area Hospital
  • Providence Newberg Medical Center
  • Saint Alphonsus Medical Center-OntarioRecruiting
  • Providence Portland Medical Center
  • Providence Saint Vincent Medical Center
  • Saint Charles Health System-Redmond
  • Lehigh Valley Hospital-Cedar CrestRecruiting
  • Lehigh Valley Hospital - MuhlenbergRecruiting
  • Pocono Medical Center
  • Lehigh Valley Hospital-Hazleton
  • Ralph H Johnson VA Medical Center
  • Gibbs Cancer Center-Gaffney
  • Gibbs Cancer Center-PelhamRecruiting
  • North Grove Medical Park
  • Spartanburg Medical CenterRecruiting
  • Spartanburg Medical Center - Mary Black Campus
  • MGC Hematology Oncology-Union
  • University of Texas Medical Branch
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterRecruiting
  • UTMB Cancer Center at Victory Lakes
  • Audie L Murphy VA HospitalRecruiting
  • University of Texas Health Science Center at San AntonioRecruiting
  • American Fork Hospital / Huntsman Intermountain Cancer Center
  • Sandra L Maxwell Cancer Center
  • Logan Regional Hospital
  • Intermountain Medical Center
  • McKay-Dee Hospital Center
  • Utah Valley Regional Medical Center
  • Riverton Hospital
  • Saint George Regional Medical Center
  • Utah Cancer Specialists-Salt Lake City
  • LDS Hospital
  • Providence Regional Cancer System-Aberdeen
  • MultiCare Auburn Medical Center
  • PeaceHealth Saint Joseph Medical Center
  • Providence Regional Cancer System-Centralia
  • Swedish Cancer Institute-Edmonds
  • Providence Regional Cancer Partnership
  • MultiCare Gig Harbor Medical Park
  • Swedish Cancer Institute-Issaquah
  • Kadlec Clinic Hematology and OncologyRecruiting
  • Providence Regional Cancer System-Lacey
  • PeaceHealth Saint John Medical Center
  • Jefferson HealthcareRecruiting
  • MultiCare Good Samaritan Hospital
  • Pacific Gynecology Specialists
  • Swedish Medical Center-Ballard Campus
  • Swedish Medical Center-Cherry Hill
  • Swedish Medical Center-First Hill
  • PeaceHealth United General Medical Center
  • Providence Regional Cancer System-Shelton
  • MultiCare Deaconess Cancer and Blood Specialty Center - Valley
  • MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
  • MultiCare Deaconess Cancer and Blood Specialty Center - North
  • MultiCare Tacoma General Hospital
  • PeaceHealth Southwest Medical Center
  • Providence Saint Mary Regional Cancer Center
  • Providence Regional Cancer System-Yelm
  • Marshfield Medical Center-EC Cancer CenterRecruiting
  • Marshfield Medical Center-MarshfieldRecruiting
  • Medical College of WisconsinRecruiting
  • Marshfield Clinic-Minocqua CenterRecruiting
  • ProHealth D N Greenwald CenterRecruiting
  • Cancer Center of Western Wisconsin
  • ProHealth Oconomowoc Memorial HospitalRecruiting
  • Marshfield Medical Center-Rice LakeRecruiting
  • Marshfield Medical Center-River Region at Stevens PointRecruiting
  • ProHealth Waukesha Memorial HospitalRecruiting
  • UW Cancer Center at ProHealth CareRecruiting
  • Marshfield Medical Center - WestonRecruiting
  • Cheyenne Regional Medical Center-West
  • Billings Clinic-Cody
  • Welch Cancer Center
  • FHP Health Center-Guam
  • Cancer Center-Metro Medical Center Bayamon
  • HIMA San Pablo Oncologic Hospital
  • Doctors Cancer Center
  • Instituto Oncologia Moderna Ponce
  • San Juan Community Oncology Group
  • Centro Comprensivo de Cancer de UPR
  • San Juan City HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (pembrolizumab, gemcitabine hydrochloride)

Arm Description

INDUCTION: Patients receive pembrolizumab IV over 25-40 minutes on day 1 of cycles 1-4. Patients also receive gemcitabine hydrochloride intravesically on days 1, 8 and 15 of cycles 1 and 2. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Beginning cycle 5, patients with no evidence of disease after induction receive pembrolizumab IV over 25-40 minutes and gemcitabine intravesically on day 1. Treatment repeats every 3 weeks for 12 cycles in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Complete response rate in the carcinoma in situ (CIS) subpopulation
A complete response, only for patients with a CIS component, is a cystoscopy without evidence of bladder tumor and negative biopsy (including directed biopsies to any suspicious areas and in addition random bladder biopsies including trigone, left lateral wall, right lateral wall, posterior bladder, dome of bladder, and the prostatic urethra in men), and negative cytology for high grade disease.
Event-free survival at 18 months
For patients without a documented event and who are still alive, they will be censored at last disease assessment. For patients who start any subsequent ant-cancer therapy without any reported events will be censored at their last disease assessment. will be obtained with a Kaplan-Meier estimator (using the Greenwood formula to estimate the variance) for the entire 153 patient group consisting of patients with CIS, CIS with Ta/T1 or Ta or T1 disease. A 90% confidence interval will be generated for the 18-month EFS estimate.

Secondary Outcome Measures

Incidence of adverse events
Adverse events will be assessed based on the National Cancer Institute (NCI) common toxicity criteria (Common Terminology Criteria for Adverse Events [CTACAE] version [v] 5.0).
Duration of response (DOR)
Analysis will only include those patients in the CIS population who achieve a response. Patients who are alive and without a documented progression at the time of analysis will be censored at the time of the last disease status evaluation. The Kaplan-Meier product-limit estimator will be used to estimate DOR, medians and 95% confidence intervals (CI).
Progression-free survival (PFS)
Surviving patients without any documented progressions will be censored at the date of last known contact. Progression will be defined as the development of muscle invasive bladder cancer or metastatic urothelial cancer (nodal and/or distant). The Kaplan-Meier product-limit estimator will be used to estimate PFS, medians and 95% CI.
Overall survival (OS)
Surviving patients will be censored at the date of last known contact. The Kaplan-Meier product-limit estimator will be used to estimate OS, medians and 95% CI.
Cystectomy-free survival
The Kaplan-Meier product-limit estimator will be used to estimate cystectomy-free survival, medians and 95% CI.
Recurrence free survival (RFS)
Surviving patients without any documented recurrence will be censored at the date of last known contact. Recurrence will be defined as the development of high-grade bladder cancer for patients with a CIS component only and those without a CIS component. The Kaplan-Meier product-limit estimator will be used to estimate RFS, medians and 95% CI.

Full Information

First Posted
November 14, 2019
Last Updated
October 20, 2023
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04164082
Brief Title
Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
Official Title
Phase II Trial of Intravesical Gemcitabine and MK-3475 (Pembrolizumab) in the Treatment of Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2020 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Chemotherapy drugs, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine may delay the return of BCG-unresponsive bladder cancer for longer period compared to gemcitabine alone.
Detailed Description
PRIMARY OBJECTIVES: I. Estimate the 6-month complete response rate of treatment with intravesical gemcitabine hydrochloride (gemcitabine) in combination with MK-3475 (pembrolizumab) in patients with Bacillus Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) that have a carcinoma in situ (CIS) component. II. Estimate the 18 month event-free survival (EFS) rate for all patients with BCG-unresponsive NMIBC receiving intravesical gemcitabine in combination with MK-3475 (pembrolizumab). SECONDARY OBJECTIVES: I. To characterize the safety profile of the combination of intravesical gemcitabine with MK-3475 (pembrolizumab) with BCG-unresponsive NMIBC (CIS or high grade Ta and T1 with or without a CIS component). II. To estimate progression-free survival (PFS) of patients with BCG-unresponsive NMIBC treated with intravesical gemcitabine in combination with MK-3475 (pembrolizumab). III. To estimate overall survival (OS) of patients with BCG-unresponsive NMIBC treated with intravesical gemcitabine in combination with MK-3475 (pembrolizumab). IV. To estimate cystectomy-free survival of patients with BCG-unresponsive NMIBC treated with intravesical gemcitabine in combination with MK-3475 (pembrolizumab). V. To estimate recurrence-free survival (RFS) for patients with a CIS component only and those without a CIS component. EXPLORATORY OBJECTIVES: I. To assess correlation between tumor mutation burden (TMB) and EFS and 6-month complete response (CR) rate. II. To assess correlation between specific genomic alterations (single nucleotide variant [SNV] and copy number gains/loss) and EFS and 6-month complete response rate. III. To assess correlation between APOBEC mutational signature and EFS and 6-month complete response rate. IV. To assess correlation between immune gene signatures (IGS) and EFS and 6-month complete response rate. V. To assess correlation between PD-L1 ribonucleic acid (RNA) levels and EFS and 6-month complete response rate. VI. To assess correlation between RNA molecular subtype and EFS and 6-month complete response rate. VII. To assess correlation between intratumoral T-cell receptor (TCR) clonality and EFS and 6-month complete response rate. VIII. To assess correlation between changes in peripheral blood TCR clonality and EFS and 6-month complete response rate. IX. To assess EFS in patients with urine cell free deoxyribonucleic acid (DNA) (cfDNA) + versus (vs.) patients with cfDNA. OUTLINE: INDUCTION: Patients receive pembrolizumab intravenously (IV) over 25-40 minutes on day 1 of cycles 1-4. Patients also receive gemcitabine hydrochloride intravesically on days 1, 8 and 15 of cycles 1 and 2. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Beginning cycle 5, patients with no evidence of disease after induction receive pembrolizumab IV over 25-40 minutes and gemcitabine intravesically on day 1. Treatment repeats every 3 weeks for 12 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients with evidence of disease (recurrence or progression) or stop study treatment to receive non-protocol treatment during induction are followed up every 6 months for 5 years. Patients who go off treatment due to any reason other than recurrence/progression or receiving subsequent non-protocol treatment during induction will go to clinical follow-up until evidence of disease progression/recurrence. Thereafter, patients are followed up every 6 months until 5 years from registration. Patients who complete scheduled maintenance treatment according to protocol therapy are followed up every 3 months for 2 years and then every 6 months for 3 years until disease progression/recurrence or receiving subsequent non-protocol treatment. Thereafter, patients are followed up every 6 months until 5 years from registration. Patients who have evidence of disease during maintenance therapy are followed up every 6 months until 5 years from registration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Urothelial Carcinoma In Situ, Invasive Bladder Mixed Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
161 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (pembrolizumab, gemcitabine hydrochloride)
Arm Type
Experimental
Arm Description
INDUCTION: Patients receive pembrolizumab IV over 25-40 minutes on day 1 of cycles 1-4. Patients also receive gemcitabine hydrochloride intravesically on days 1, 8 and 15 of cycles 1 and 2. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Beginning cycle 5, patients with no evidence of disease after induction receive pembrolizumab IV over 25-40 minutes and gemcitabine intravesically on day 1. Treatment repeats every 3 weeks for 12 cycles in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine Hydrochloride
Other Intervention Name(s)
dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemcitabine HCI, Gemzar, LY-188011, LY188011
Intervention Description
Given intravesically
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
BCD-201, Keytruda, Lambrolizumab, MK-3475, Pembrolizumab Biosimilar BCD-201, SCH 900475
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Complete response rate in the carcinoma in situ (CIS) subpopulation
Description
A complete response, only for patients with a CIS component, is a cystoscopy without evidence of bladder tumor and negative biopsy (including directed biopsies to any suspicious areas and in addition random bladder biopsies including trigone, left lateral wall, right lateral wall, posterior bladder, dome of bladder, and the prostatic urethra in men), and negative cytology for high grade disease.
Time Frame
At 6 months (end of cycle 8, week 25)
Title
Event-free survival at 18 months
Description
For patients without a documented event and who are still alive, they will be censored at last disease assessment. For patients who start any subsequent ant-cancer therapy without any reported events will be censored at their last disease assessment. will be obtained with a Kaplan-Meier estimator (using the Greenwood formula to estimate the variance) for the entire 153 patient group consisting of patients with CIS, CIS with Ta/T1 or Ta or T1 disease. A 90% confidence interval will be generated for the 18-month EFS estimate.
Time Frame
From the date of study registration to the first documentation of an event or death whichever comes first, assessed up to 18 months
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
Adverse events will be assessed based on the National Cancer Institute (NCI) common toxicity criteria (Common Terminology Criteria for Adverse Events [CTACAE] version [v] 5.0).
Time Frame
Up to 5 years post treatment
Title
Duration of response (DOR)
Description
Analysis will only include those patients in the CIS population who achieve a response. Patients who are alive and without a documented progression at the time of analysis will be censored at the time of the last disease status evaluation. The Kaplan-Meier product-limit estimator will be used to estimate DOR, medians and 95% confidence intervals (CI).
Time Frame
From the time a patient had a documented response (the time would start at the time a response was first noted) until disease-progression, assessed up to 5 years
Title
Progression-free survival (PFS)
Description
Surviving patients without any documented progressions will be censored at the date of last known contact. Progression will be defined as the development of muscle invasive bladder cancer or metastatic urothelial cancer (nodal and/or distant). The Kaplan-Meier product-limit estimator will be used to estimate PFS, medians and 95% CI.
Time Frame
From the date of study registration to the date of progression or death due to any cause, whichever occurs first, assessed up to 5 years
Title
Overall survival (OS)
Description
Surviving patients will be censored at the date of last known contact. The Kaplan-Meier product-limit estimator will be used to estimate OS, medians and 95% CI.
Time Frame
From the date of study registration to date of death due to any cause, assessed up to 5 years
Title
Cystectomy-free survival
Description
The Kaplan-Meier product-limit estimator will be used to estimate cystectomy-free survival, medians and 95% CI.
Time Frame
From the date of study registration to the date of cystectomy for all patients
Title
Recurrence free survival (RFS)
Description
Surviving patients without any documented recurrence will be censored at the date of last known contact. Recurrence will be defined as the development of high-grade bladder cancer for patients with a CIS component only and those without a CIS component. The Kaplan-Meier product-limit estimator will be used to estimate RFS, medians and 95% CI.
Time Frame
From the date of study registration to the first documentation of recurrence or death due to any cause, assessed up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: High grade Ta, T1 or CIS urothelial carcinoma. Accrual of patients with Ta or T1 disease may be closed to ensure adequate patients enrollment to meet the primary endpoint Persistent disease (defined as not achieving disease free status) after completing therapy with at least induction BCG (>= 5 doses) and the first round of maintenance or second induction course (>= 2 doses). The subsequent round of BCG, either maintenance or repeat induction, must be given within 6 months of initial induction BCG. Persistent high risk NMIBC (T1, high grade Ta and/or CIS) must be within 9 months of the last BCG instillation despite having received adequate BCG as defined above. Registration must be within 12 months of last BCG instillation High grade T1 after completing therapy with at least induction BCG (>= 5 doses) or after completing therapy with at least induction BCG (>= 5 doses) and first round of maintenance or second induction course (>= 2 doses). The subsequent round of BCG, either maintenance or repeat induction, must be given within 6 months of initial induction BCG Disease recurrence (T1) must be within 9 months of the last BCG instillation despite having received adequate BCG as defined above Registration must be within 12 months of last BCG instillation Patients who are disease free at 6 months after starting BCG but have high grade recurrence (T1, Ta, CIS) while on maintenance therapy would be eligible The recurrence must be within 6 months of the last BCG dose. Registration must be within 12 months of last maintenance BCG instillation Patients must be deemed unfit for radical cystectomy by the treating physician or refuse radical cystectomy All patients must have histologically confirmed urothelial cancer of the bladder within 60 days prior to registration All visible tumor must be completely resected 60 days prior to registration (residual pure CIS is permitted) All patients must have had a cystoscopy (or transurethral resection of bladder tumor [TURBT] with complete resection) without papillary tumor and negative urinary cytology within 28 days of registration. (positive cytology is allowed in patients with CIS) All patients with T1 tumors must undergo a re-staging TURBT within 60 days of registration. There must be uninvolved muscularis propria present in the re-staging TURBT. The initial TURBT prior to re-staging TURBT may be greater than 60 days prior to registration Patients must have had imaging with computed tomography (CT) or magnetic resonance imaging (MRI) abdomen/pelvis within 90 days of registration demonstrating no evidence of metastasis. Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Include as applicable: Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom) A woman of childbearing potential (WOCBP) must not have a positive urine pregnancy test within 7 days prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required Patients must not be pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with registration through the last dose of treatment Age >= 18 years Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Absolute neutrophil count (ANC) >= 1,500/mm^3 Platelet count >= 100,000/mm^3 Hemoglobin >= 9.0 g/dL Creatinine =< 1.5 x upper limit of normal (ULN) In patients with creatinine > 1.5 x ULN, if measured or calculated creatinine clearance > 30 mL/min, then patient is eligible Total bilirubin =< 1.5 x ULN In patients with a total bilirubin > 1.5 x ULN, if direct bilirubin < 1.0 X ULN, then patient is eligible Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =< 2.5 x ULN Patients with human immunodeficiency virus (HIV) are eligible with the following: On effective anti-retroviral therapy with undetectable viral load within 6 months of registration Exclusion Criteria: Mixed variant histology (adenocarcinoma, squamous cell carcinoma) is eligible, but pure variant histology is ineligible. Patients cannot have had a history of urothelial carcinoma in the ureters or prostatic urethra 24 months prior to registration Patients must not be currently participating in or have participated in a study of an investigational agent or have used an investigational device within 4 weeks prior to study registration Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been more than 4 weeks after the last dose of the previous investigational agent at time of registration Patients must not have prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) Patients must not have undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years prior to registration. (Participants who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of graft versus host disease [GVHD]) Patients must not have received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment Note: Participants must have recovered from all adverse events (AEs) due to previous therapies to =< grade 1 or baseline. Participants with =< grade 2 neuropathy may be eligible Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment Patients must not have received prior radiotherapy within 2 weeks of study registration. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis Patients must not have received radiation therapy to the lung that is > 30 Gy within 6 months prior to trial registration Patients must not have had an active autoimmune disease requiring systemic treatment within 24 months prior to registration. Autoimmune diseases include, but not limited to, lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis Patients must not have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed Patients must not have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study Patients must not have active tuberculosis Patients must not have been treated with antibiotics for an active infection within 14 days prior to registration. Prophylactic antibiotics are permitted. Treatment for a urinary tract infection (UTI) is allowed but must be deemed adequately treated by the treating physician prior the start of cycle 1 (C1) day 1 (D1) Patients must not have a history of idiopathic pulmonary fibrosis or organizing pneumonia Patients must not have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis HIV-infected participants must not have a history of Kaposi sarcoma and/or multicentric Castleman disease Patients must not have a known additional malignancy that has had progression or has required active treatment in the last three years. Exceptions include basal or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. A history of prostate cancer that was treated with definitive intent is allowed, provided that the prostate-specific antigen (PSA) is undetectable for at least 1 year while off androgen deprivation therapy Patients must not have known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment Patients must not have severe hypersensitivity (>= grade 3) to pembrolizumab and/or any of its excipients Patients must not have an active infection requiring systemic therapy Patients must not have a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected) infection Note: No testing for hepatitis B and hepatitis C is required unless mandated by a local health authority Patients must not have received live vaccines within 30 days of study drug administration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed. COVID-19 vaccinations are permitted. Physicians should consider whether any of the following may render the patient inappropriate for this protocol: Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael E Woods
Organizational Affiliation
Alliance for Clinical Trials in Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
205-934-0220
Email
tmyrick@uab.edu
First Name & Middle Initial & Last Name & Degree
Charles C. Peyton
Facility Name
Anchorage Associates in Radiation Medicine
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
98508
Country
United States
Individual Site Status
Suspended
Facility Name
Anchorage Radiation Therapy Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99504
Country
United States
Individual Site Status
Suspended
Facility Name
Alaska Breast Care and Surgery LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Suspended
Facility Name
Alaska Oncology and Hematology LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Suspended
Facility Name
Alaska Women's Cancer Care
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Suspended
Facility Name
Anchorage Oncology Centre
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Suspended
Facility Name
Katmai Oncology Group
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Suspended
Facility Name
Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Suspended
Facility Name
Fairbanks Memorial Hospital
City
Fairbanks
State/Province
Alaska
ZIP/Postal Code
99701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
907-458-3043
Email
Veronica.Stevenson@foundationhealth.org
First Name & Middle Initial & Last Name & Degree
Nicholas DiBella
Facility Name
Cancer Center at Saint Joseph's
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
602-406-0777
Email
Research-cancerinstitute@dignityhealth.org
First Name & Middle Initial & Last Name & Degree
Shahzad Siddique
Facility Name
Mayo Clinic Hospital in Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
855-776-0015
First Name & Middle Initial & Last Name & Degree
Mark D. Tyson
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
855-776-0015
First Name & Middle Initial & Last Name & Degree
Mark D. Tyson
Facility Name
Mercy Hospital Fort Smith
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72903
Country
United States
Individual Site Status
Suspended
Facility Name
Providence Saint Joseph Medical Center/Disney Family Cancer Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Individual Site Status
Suspended
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
916-734-3089
First Name & Middle Initial & Last Name & Degree
Marc Dall'Era
Facility Name
Rocky Mountain Cancer Centers-Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
303-777-2663
Email
info@westernstatesncorp.org
First Name & Middle Initial & Last Name & Degree
Nicholas DiBella
Facility Name
The Medical Center of Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Individual Site Status
Suspended
Facility Name
Boulder Community Hospital
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Individual Site Status
Suspended
Facility Name
Boulder Community Foothills Hospital
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Individual Site Status
Suspended
Facility Name
Rocky Mountain Cancer Centers-Boulder
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
303-777-2663
Email
info@westernstatesncorp.org
First Name & Middle Initial & Last Name & Degree
Nicholas DiBella
Facility Name
Rocky Mountain Cancer Centers - Centennial
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
303-777-2663
Email
info@westernstatesncorp.org
First Name & Middle Initial & Last Name & Degree
Nicholas DiBella
Facility Name
Cancer Center of Colorado at Sloan's Lake
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Individual Site Status
Suspended
Facility Name
National Jewish Health-Main Campus
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Individual Site Status
Suspended
Facility Name
The Women's Imaging Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Individual Site Status
Suspended
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Suspended
Facility Name
Presbyterian - Saint Lukes Medical Center - Health One
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Suspended
Facility Name
Rocky Mountain Cancer Centers-Midtown
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
303-777-2663
Email
info@westernstatesncorp.org
First Name & Middle Initial & Last Name & Degree
Nicholas DiBella
Facility Name
SCL Health Saint Joseph Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Suspended
Facility Name
Rocky Mountain Cancer Centers-Rose
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
303-777-2663
Email
info@westernstatesncorp.org
First Name & Middle Initial & Last Name & Degree
Nicholas DiBella
Facility Name
Rose Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Individual Site Status
Suspended
Facility Name
Western Surgical Care
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Individual Site Status
Suspended
Facility Name
Mountain Blue Cancer Care Center - Swedish
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Individual Site Status
Suspended
Facility Name
Rocky Mountain Cancer Centers - Swedish
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Individual Site Status
Suspended
Facility Name
Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Individual Site Status
Suspended
Facility Name
The Melanoma and Skin Cancer Institute
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Individual Site Status
Suspended
Facility Name
National Jewish Health-Western Hematology Oncology
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Mary's Hospital and Regional Medical Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Individual Site Status
Suspended
Facility Name
North Colorado Medical Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Individual Site Status
Suspended
Facility Name
Good Samaritan Medical Center
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Individual Site Status
Suspended
Facility Name
Rocky Mountain Cancer Centers-Lakewood
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Individual Site Status
Suspended
Facility Name
Rocky Mountain Cancer Centers-Littleton
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
303-777-2663
Email
info@westernstatesncorp.org
First Name & Middle Initial & Last Name & Degree
Nicholas DiBella
Facility Name
Rocky Mountain Cancer Centers-Sky Ridge
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
303-777-2663
Email
info@westernstatesncorp.org
First Name & Middle Initial & Last Name & Degree
Nicholas DiBella
Facility Name
Sky Ridge Medical Center
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Individual Site Status
Suspended
Facility Name
McKee Medical Center
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80539
Country
United States
Individual Site Status
Suspended
Facility Name
National Jewish Health-Northern Hematology Oncology
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80260
Country
United States
Individual Site Status
Suspended
Facility Name
Rocky Mountain Cancer Centers-Thornton
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80260
Country
United States
Individual Site Status
Suspended
Facility Name
SCL Health Lutheran Medical Center
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Individual Site Status
Suspended
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
202-444-2223
First Name & Middle Initial & Last Name & Degree
Lambros Stamatakis
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
202-877-8839
First Name & Middle Initial & Last Name & Degree
Lambros Stamatakis
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Suspended
Facility Name
University of Florida Health Science Center - Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
352-273-8010
Email
cancer-center@ufl.edu
First Name & Middle Initial & Last Name & Degree
Paul L. Crispen
Facility Name
Hawaii Cancer Care - Westridge
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
808-539-2273
Email
info@hawaiicancercare.com
First Name & Middle Initial & Last Name & Degree
Jeffrey L. Berenberg
Facility Name
Pali Momi Medical Center
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
808-486-6000
First Name & Middle Initial & Last Name & Degree
Jeffrey L. Berenberg
Facility Name
Queen's Cancer Center - Pearlridge
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Individual Site Status
Suspended
Facility Name
The Cancer Center of Hawaii-Pali Momi
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Individual Site Status
Suspended
Facility Name
The Queen's Medical Center - West Oahu
City
'Ewa Beach
State/Province
Hawaii
ZIP/Postal Code
96706
Country
United States
Individual Site Status
Suspended
Facility Name
Hawaii Cancer Care Inc - Waterfront Plaza
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
808-524-6115
Email
i.webster@hawaiicancercare.com
First Name & Middle Initial & Last Name & Degree
Jeffrey L. Berenberg
Facility Name
Island Urology
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Individual Site Status
Suspended
Facility Name
Queen's Cancer Cenrer - POB I
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Individual Site Status
Suspended
Facility Name
Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Individual Site Status
Suspended
Facility Name
Straub Clinic and Hospital
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
808-522-4333
First Name & Middle Initial & Last Name & Degree
Jeffrey L. Berenberg
Facility Name
University of Hawaii Cancer Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Individual Site Status
Suspended
Facility Name
Hawaii Cancer Care Inc-Liliha
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Individual Site Status
Suspended
Facility Name
Hawaii Diagnostic Radiology Services LLC
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Individual Site Status
Suspended
Facility Name
Kuakini Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Individual Site Status
Suspended
Facility Name
Queen's Cancer Center - Kuakini
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Individual Site Status
Suspended
Facility Name
The Cancer Center of Hawaii-Liliha
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Individual Site Status
Suspended
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Individual Site Status
Suspended
Facility Name
Straub Medical Center - Kahului Clinic
City
Kahului
State/Province
Hawaii
ZIP/Postal Code
96732
Country
United States
Individual Site Status
Suspended
Facility Name
Castle Medical Center
City
Kailua
State/Province
Hawaii
ZIP/Postal Code
96734
Country
United States
Individual Site Status
Suspended
Facility Name
Wilcox Memorial Hospital and Kauai Medical Clinic
City
Lihue
State/Province
Hawaii
ZIP/Postal Code
96766
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Alphonsus Cancer Care Center-Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-3671
Email
stephanie.couch@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
John M. Schallenkamp
Facility Name
Saint Luke's Cancer Institute - Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Alphonsus Cancer Care Center-Caldwell
City
Caldwell
State/Province
Idaho
ZIP/Postal Code
83605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-3671
Email
stephanie.couch@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
John M. Schallenkamp
Facility Name
Kootenai Health - Coeur d'Alene
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
406-969-6060
Email
mccinfo@mtcancer.org
First Name & Middle Initial & Last Name & Degree
John M. Schallenkamp
Facility Name
Walter Knox Memorial Hospital
City
Emmett
State/Province
Idaho
ZIP/Postal Code
83617
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Luke's Cancer Institute - Fruitland
City
Fruitland
State/Province
Idaho
ZIP/Postal Code
83619
Country
United States
Individual Site Status
Suspended
Facility Name
Idaho Urologic Institute-Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Luke's Cancer Institute - Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Luke's Cancer Institute - Nampa
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Alphonsus Cancer Care Center-Nampa
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
406-969-6060
Email
mccinfo@mtcancer.org
First Name & Middle Initial & Last Name & Degree
John M. Schallenkamp
Facility Name
Kootenai Clinic Cancer Services - Post Falls
City
Post Falls
State/Province
Idaho
ZIP/Postal Code
83854
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
406-969-6060
Email
mccinfo@mtcancer.org
First Name & Middle Initial & Last Name & Degree
John M. Schallenkamp
Facility Name
Kootenai Cancer Clinic
City
Sandpoint
State/Province
Idaho
ZIP/Postal Code
83864
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
406-969-6060
Email
mccinfo@mtcancer.org
First Name & Middle Initial & Last Name & Degree
John M. Schallenkamp
Facility Name
Saint Luke's Cancer Institute - Twin Falls
City
Twin Falls
State/Province
Idaho
ZIP/Postal Code
83301
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Anthony's Health
City
Alton
State/Province
Illinois
ZIP/Postal Code
62002
Country
United States
Individual Site Status
Suspended
Facility Name
Illinois CancerCare-Bloomington
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Individual Site Status
Suspended
Facility Name
Illinois CancerCare-Canton
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Individual Site Status
Suspended
Facility Name
Memorial Hospital of Carbondale
City
Carbondale
State/Province
Illinois
ZIP/Postal Code
62902
Country
United States
Individual Site Status
Suspended
Facility Name
SIH Cancer Institute
City
Carterville
State/Province
Illinois
ZIP/Postal Code
62918
Country
United States
Individual Site Status
Suspended
Facility Name
Illinois CancerCare-Carthage
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Individual Site Status
Suspended
Facility Name
Centralia Oncology Clinic
City
Centralia
State/Province
Illinois
ZIP/Postal Code
62801
Country
United States
Individual Site Status
Suspended
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cancer Care Specialists of Illinois - Decatur
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
217-876-4762
Email
morganthaler.jodi@mhsil.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Individual Site Status
Suspended
Facility Name
Illinois CancerCare-Dixon
City
Dixon
State/Province
Illinois
ZIP/Postal Code
61021
Country
United States
Individual Site Status
Suspended
Facility Name
Crossroads Cancer Center
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
217-876-4762
Email
morganthaler.jodi@mhsil.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Illinois CancerCare-Eureka
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Individual Site Status
Suspended
Facility Name
Illinois CancerCare-Galesburg
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Individual Site Status
Suspended
Facility Name
Western Illinois Cancer Treatment Center
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Individual Site Status
Suspended
Facility Name
Illinois CancerCare-Kewanee Clinic
City
Kewanee
State/Province
Illinois
ZIP/Postal Code
61443
Country
United States
Individual Site Status
Suspended
Facility Name
Illinois CancerCare-Macomb
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Individual Site Status
Suspended
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
708-226-4357
First Name & Middle Initial & Last Name & Degree
Michael E. Woods
Facility Name
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
City
Melrose Park
State/Province
Illinois
ZIP/Postal Code
60160
Country
United States
Individual Site Status
Suspended
Facility Name
Good Samaritan Regional Health Center
City
Mount Vernon
State/Province
Illinois
ZIP/Postal Code
62864
Country
United States
Individual Site Status
Suspended
Facility Name
Cancer Care Center of O'Fallon
City
O'Fallon
State/Province
Illinois
ZIP/Postal Code
62269
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
217-876-4762
Email
morganthaler.jodi@mhsil.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Illinois CancerCare-Ottawa Clinic
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Individual Site Status
Suspended
Facility Name
Illinois CancerCare-Pekin
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Individual Site Status
Suspended
Facility Name
Illinois CancerCare-Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Individual Site Status
Suspended
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Individual Site Status
Suspended
Facility Name
Illinois CancerCare-Peru
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Individual Site Status
Suspended
Facility Name
Valley Radiation Oncology
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Individual Site Status
Suspended
Facility Name
Illinois CancerCare-Princeton
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Individual Site Status
Suspended
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
217-545-7929
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-444-7541
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
217-528-7541
Email
pallante.beth@mhsil.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Southwest Illinois Health Services LLP
City
Swansea
State/Province
Illinois
ZIP/Postal Code
62226
Country
United States
Individual Site Status
Suspended
Facility Name
Illinois CancerCare - Washington
City
Washington
State/Province
Illinois
ZIP/Postal Code
61571
Country
United States
Individual Site Status
Suspended
Facility Name
Reid Health
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-284-7370
First Name & Middle Initial & Last Name & Degree
Muhammad O. Toor
Facility Name
Central Care Cancer Center - Garden City
City
Garden City
State/Province
Kansas
ZIP/Postal Code
67846
Country
United States
Individual Site Status
Suspended
Facility Name
Central Care Cancer Center - Great Bend
City
Great Bend
State/Province
Kansas
ZIP/Postal Code
67530
Country
United States
Individual Site Status
Suspended
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
913-588-3671
Email
KUCC_Navigation@kumc.edu
First Name & Middle Initial & Last Name & Degree
Eugene K. Lee
Facility Name
University of Kansas Hospital-Westwood Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
913-588-3671
Email
KUCC_Navigation@kumc.edu
First Name & Middle Initial & Last Name & Degree
Eugene K. Lee
Facility Name
University of Kentucky/Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
East Jefferson General Hospital
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
504-210-3539
Email
emede1@lsuhsc.edu
First Name & Middle Initial & Last Name & Degree
Scott E. Delacroix
Facility Name
LSU Healthcare Network / Metairie Multi-Specialty Clinic
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
504-210-3539
Email
emede1@lsuhsc.edu
First Name & Middle Initial & Last Name & Degree
Scott E. Delacroix
Facility Name
Louisiana State University Health Science Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Suspended
Facility Name
UM Baltimore Washington Medical Center/Tate Cancer Center
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
410-553-8100
First Name & Middle Initial & Last Name & Degree
Cherif N. Boutros
Facility Name
Lowell General Hospital
City
Lowell
State/Province
Massachusetts
ZIP/Postal Code
01854
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mercy Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
Individual Site Status
Suspended
Facility Name
Hickman Cancer Center
City
Adrian
State/Province
Michigan
ZIP/Postal Code
49221
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Bronson Battle Creek
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
616-391-1230
Email
crcwm-regulatory@crcwm.org
First Name & Middle Initial & Last Name & Degree
Kathleen J. Yost
Facility Name
Saint Joseph Mercy Brighton
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Trinity Health IHA Medical Group Hematology Oncology - Brighton
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Saint Joseph Mercy Canton
City
Canton
State/Province
Michigan
ZIP/Postal Code
48188
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Trinity Health IHA Medical Group Hematology Oncology - Canton
City
Canton
State/Province
Michigan
ZIP/Postal Code
48188
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Caro Cancer Center
City
Caro
State/Province
Michigan
ZIP/Postal Code
48723
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Joseph Mercy Chelsea
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Hematology Oncology Consultants-Clarkston
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Individual Site Status
Suspended
Facility Name
Newland Medical Associates-Clarkston
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Individual Site Status
Suspended
Facility Name
Ascension Saint John Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-343-3166
Email
karen.forman@ascension.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Great Lakes Cancer Management Specialists-Doctors Park
City
East China Township
State/Province
Michigan
ZIP/Postal Code
48054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-343-3166
Email
karen.forman@ascension.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Genesee Cancer and Blood Disease Treatment Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
810-762-8038
Email
wstrong@ghci.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Genesee Hematology Oncology PC
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
810-762-8038
Email
wstrong@ghci.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
810-762-8038
Email
wstrong@ghci.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
810-762-8038
Email
wstrong@ghci.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Helen DeVos Children's Hospital at Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Suspended
Facility Name
Spectrum Health at Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
616-391-1230
Email
crcwm-regulatory@crcwm.org
First Name & Middle Initial & Last Name & Degree
Kathleen J. Yost
Facility Name
Trinity Health Grand Rapids Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Suspended
Facility Name
Academic Hematology Oncology Specialists
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-343-3166
Email
karen.forman@ascension.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-343-3166
Email
karen.forman@ascension.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Michigan Breast Specialists-Grosse Pointe Woods
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Individual Site Status
Suspended
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
616-391-1230
Email
crcwm-regulatory@crcwm.org
First Name & Middle Initial & Last Name & Degree
Kathleen J. Yost
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
616-391-1230
Email
crcwm-regulatory@crcwm.org
First Name & Middle Initial & Last Name & Degree
Kathleen J. Yost
Facility Name
Ascension Borgess Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
616-391-1230
Email
crcwm-regulatory@crcwm.org
First Name & Middle Initial & Last Name & Degree
Kathleen J. Yost
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Individual Site Status
Suspended
Facility Name
Sparrow Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
517-364-9400
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Hope Cancer Clinic
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Individual Site Status
Suspended
Facility Name
Trinity Health Saint Mary Mercy Livonia Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Great Lakes Cancer Management Specialists-Macomb Medical Campus
City
Macomb
State/Province
Michigan
ZIP/Postal Code
48044
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-343-3166
Email
karen.forman@ascension.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Michigan Breast Specialists-Macomb Township
City
Macomb
State/Province
Michigan
ZIP/Postal Code
48044
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Mary's Oncology/Hematology Associates of Marlette
City
Marlette
State/Province
Michigan
ZIP/Postal Code
48453
Country
United States
Individual Site Status
Suspended
Facility Name
Toledo Clinic Cancer Centers-Monroe
City
Monroe
State/Province
Michigan
ZIP/Postal Code
48162
Country
United States
Individual Site Status
Suspended
Facility Name
Trinity Health Muskegon Hospital
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49444
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
616-391-1230
Email
crcwm-regulatory@crcwm.org
First Name & Middle Initial & Last Name & Degree
Kathleen J. Yost
Facility Name
Lakeland Hospital Niles
City
Niles
State/Province
Michigan
ZIP/Postal Code
49120
Country
United States
Individual Site Status
Suspended
Facility Name
Cancer and Hematology Centers of Western Michigan - Norton Shores
City
Norton Shores
State/Province
Michigan
ZIP/Postal Code
49444
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
616-391-1230
Email
connie.szczepanek@crcwm.org
First Name & Middle Initial & Last Name & Degree
Kathleen J. Yost
Facility Name
21st Century Oncology-Pontiac
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Individual Site Status
Suspended
Facility Name
Hope Cancer Center
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Individual Site Status
Suspended
Facility Name
Newland Medical Associates-Pontiac
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Individual Site Status
Suspended
Facility Name
Spectrum Health Reed City Hospital
City
Reed City
State/Province
Michigan
ZIP/Postal Code
49677
Country
United States
Individual Site Status
Suspended
Facility Name
Great Lakes Cancer Management Specialists-Rochester Hills
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48309
Country
United States
Individual Site Status
Suspended
Facility Name
Ascension Saint Mary's Hospital
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
989-907-8411
Email
lori.srebinski@ascension.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Oncology Hematology Associates of Saginaw Valley PC
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
989-907-8411
Email
lori.srebinski@ascension.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Lakeland Medical Center Saint Joseph
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Individual Site Status
Suspended
Facility Name
Marie Yeager Cancer Center
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
616-391-1230
Email
crcwm-regulatory@crcwm.org
First Name & Middle Initial & Last Name & Degree
Kathleen J. Yost
Facility Name
Bhadresh Nayak MD PC-Sterling Heights
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48312
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-343-3166
Email
karen.forman@ascension.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Ascension Saint Joseph Hospital
City
Tawas City
State/Province
Michigan
ZIP/Postal Code
48764
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
989-907-8411
Email
lori.srebinski@ascension.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
616-391-1230
Email
crcwm-regulatory@crcwm.org
First Name & Middle Initial & Last Name & Degree
Kathleen J. Yost
Facility Name
Advanced Breast Care Center PLLC
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Individual Site Status
Suspended
Facility Name
Great Lakes Cancer Management Specialists-Macomb Professional Building
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-343-3166
Email
karen.forman@ascension.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Macomb Hematology Oncology PC
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Individual Site Status
Suspended
Facility Name
Michigan Breast Specialists-Warren
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Individual Site Status
Suspended
Facility Name
Saint John Macomb-Oakland Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-343-3166
Email
karen.forman@ascension.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Saint Mary's Oncology/Hematology Associates of West Branch
City
West Branch
State/Province
Michigan
ZIP/Postal Code
48661
Country
United States
Individual Site Status
Suspended
Facility Name
University of Michigan Health - West
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
616-391-1230
Email
crcwm-regulatory@crcwm.org
First Name & Middle Initial & Last Name & Degree
Kathleen J. Yost
Facility Name
Huron Gastroenterology PC
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Fairview Ridges Hospital
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Individual Site Status
Suspended
Facility Name
Minnesota Oncology - Burnsville
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Individual Site Status
Suspended
Facility Name
Cambridge Medical Center
City
Cambridge
State/Province
Minnesota
ZIP/Postal Code
55008
Country
United States
Individual Site Status
Suspended
Facility Name
Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Individual Site Status
Suspended
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Individual Site Status
Suspended
Facility Name
Unity Hospital
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Fairview Clinics and Surgery Center Maple Grove
City
Maple Grove
State/Province
Minnesota
ZIP/Postal Code
55369
Country
United States
Individual Site Status
Suspended
Facility Name
Minnesota Oncology Hematology PA-Maplewood
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Individual Site Status
Suspended
Facility Name
Saint John's Hospital - Healtheast
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Individual Site Status
Suspended
Facility Name
Abbott-Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Suspended
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Individual Site Status
Suspended
Facility Name
Health Partners Inc
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Individual Site Status
Suspended
Facility Name
Monticello Cancer Center
City
Monticello
State/Province
Minnesota
ZIP/Postal Code
55362
Country
United States
Individual Site Status
Suspended
Facility Name
New Ulm Medical Center
City
New Ulm
State/Province
Minnesota
ZIP/Postal Code
56073
Country
United States
Individual Site Status
Suspended
Facility Name
Fairview Northland Medical Center
City
Princeton
State/Province
Minnesota
ZIP/Postal Code
55371
Country
United States
Individual Site Status
Suspended
Facility Name
North Memorial Medical Health Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Individual Site Status
Suspended
Facility Name
Park Nicollet Clinic - Saint Louis Park
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Individual Site Status
Suspended
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Individual Site Status
Suspended
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Francis Regional Medical Center
City
Shakopee
State/Province
Minnesota
ZIP/Postal Code
55379
Country
United States
Individual Site Status
Suspended
Facility Name
Lakeview Hospital
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
Individual Site Status
Suspended
Facility Name
Ridgeview Medical Center
City
Waconia
State/Province
Minnesota
ZIP/Postal Code
55387
Country
United States
Individual Site Status
Suspended
Facility Name
Rice Memorial Hospital
City
Willmar
State/Province
Minnesota
ZIP/Postal Code
56201
Country
United States
Individual Site Status
Suspended
Facility Name
Minnesota Oncology Hematology PA-Woodbury
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Individual Site Status
Suspended
Facility Name
Fairview Lakes Medical Center
City
Wyoming
State/Province
Minnesota
ZIP/Postal Code
55092
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Louis Cancer and Breast Institute-Ballwin
City
Ballwin
State/Province
Missouri
ZIP/Postal Code
63011
Country
United States
Individual Site Status
Suspended
Facility Name
Central Care Cancer Center - Bolivar
City
Bolivar
State/Province
Missouri
ZIP/Postal Code
65613
Country
United States
Individual Site Status
Suspended
Facility Name
Cox Cancer Center Branson
City
Branson
State/Province
Missouri
ZIP/Postal Code
65616
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Francis Medical Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
573-334-2230
Email
sfmc@sfmc.net
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Southeast Cancer Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Luke's Hospital
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-205-6936
First Name & Middle Initial & Last Name & Degree
Joseph Sokhn
Facility Name
MU Health - University Hospital/Ellis Fischel Cancer Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
573-882-7440
First Name & Middle Initial & Last Name & Degree
Kushal Naha
Facility Name
Parkland Health Center - Farmington
City
Farmington
State/Province
Missouri
ZIP/Postal Code
63640
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-996-5569
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Capital Region Southwest Campus
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Individual Site Status
Suspended
Facility Name
Freeman Health System
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Individual Site Status
Suspended
Facility Name
Mercy Hospital Joplin
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Individual Site Status
Suspended
Facility Name
Delbert Day Cancer Institute at PCRMC
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Individual Site Status
Suspended
Facility Name
Mercy Clinic-Rolla-Cancer and Hematology
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Individual Site Status
Suspended
Facility Name
Heartland Regional Medical Center
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Louis Cancer and Breast Institute-South City
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Individual Site Status
Suspended
Facility Name
Mercy Hospital South
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Individual Site Status
Suspended
Facility Name
Missouri Baptist Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-996-5569
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Mercy Hospital Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-251-7066
First Name & Middle Initial & Last Name & Degree
Jay W. Carlson
Facility Name
Sainte Genevieve County Memorial Hospital
City
Sainte Genevieve
State/Province
Missouri
ZIP/Postal Code
63670
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-996-5569
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Mercy Hospital Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Individual Site Status
Suspended
Facility Name
CoxHealth South Hospital
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Individual Site Status
Suspended
Facility Name
Missouri Baptist Sullivan Hospital
City
Sullivan
State/Province
Missouri
ZIP/Postal Code
63080
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-996-5569
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Missouri Baptist Outpatient Center-Sunset Hills
City
Sunset Hills
State/Province
Missouri
ZIP/Postal Code
63127
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-996-5569
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Mercy Hospital Washington
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Individual Site Status
Suspended
Facility Name
Community Hospital of Anaconda
City
Anaconda
State/Province
Montana
ZIP/Postal Code
59711
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
406-969-6060
Email
mccinfo@mtcancer.org
First Name & Middle Initial & Last Name & Degree
John M. Schallenkamp
Facility Name
Billings Clinic Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-996-2663
Email
research@billingsclinic.org
First Name & Middle Initial & Last Name & Degree
John M. Schallenkamp
Facility Name
Saint Vincent Healthcare
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Vincent Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Individual Site Status
Suspended
Facility Name
Bozeman Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
406-969-6060
Email
mccinfo@mtcancer.org
First Name & Middle Initial & Last Name & Degree
John M. Schallenkamp
Facility Name
Saint James Community Hospital and Cancer Treatment Center
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Individual Site Status
Suspended
Facility Name
Benefis Healthcare- Sletten Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
406-969-6060
Email
mccinfo@mtcancer.org
First Name & Middle Initial & Last Name & Degree
John M. Schallenkamp
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Individual Site Status
Suspended
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
406-969-6060
Email
mccinfo@mtcancer.org
First Name & Middle Initial & Last Name & Degree
John M. Schallenkamp
Facility Name
Saint Patrick Hospital - Community Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Individual Site Status
Suspended
Facility Name
Community Medical Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
406-969-6060
Email
mccinfo@mtcancer.org
First Name & Middle Initial & Last Name & Degree
John M. Schallenkamp
Facility Name
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-639-6918
Email
cancer.research.nurse@dartmouth.edu
First Name & Middle Initial & Last Name & Degree
Einar F. Sverrisson
Facility Name
Memorial Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Eugene J. Pietzak
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Eugene J. Pietzak
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Eugene J. Pietzak
Facility Name
The Valley Hospital-Luckow Pavilion
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Neurosurgeons of New Jersey-Ridgewood
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Valley Health System-Hematology/Oncology
City
Westwood
State/Province
New Jersey
ZIP/Postal Code
07675
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Eugene J. Pietzak
Facility Name
Arnot Ogden Medical Center/Falck Cancer Center
City
Elmira
State/Province
New York
ZIP/Postal Code
14905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
607-271-7000
First Name & Middle Initial & Last Name & Degree
Serge Dauphin
Facility Name
The New York Hospital Medical Center of Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Eugene J. Pietzak
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Eugene J. Pietzak
Facility Name
NYP/Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-746-1848
First Name & Middle Initial & Last Name & Degree
Cora N. Sternberg
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-862-2215
First Name & Middle Initial & Last Name & Degree
Shenhong Wu
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Eugene J. Pietzak
Facility Name
UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-668-0683
Email
cancerclinicaltrials@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Matthew I. Milowsky
Facility Name
University of North Carolina-Hillsborough Campus
City
Hillsborough
State/Province
North Carolina
ZIP/Postal Code
27278
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-668-0683
Email
cancerclinicaltrials@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Matthew I. Milowsky
Facility Name
Indu and Raj Soin Medical Center
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45431
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Saint Elizabeth Boardman Hospital
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dayton Physicians LLC-Miami Valley South
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Miami Valley Hospital South
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Individual Site Status
Suspended
Facility Name
Oncology Hematology Care Inc-Kenwood
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dayton Physician LLC-Miami Valley Hospital North
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Miami Valley Hospital North
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Individual Site Status
Suspended
Facility Name
Armes Family Cancer Center
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Blanchard Valley Hospital
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Orion Cancer Care
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Atrium Medical Center-Middletown Regional Hospital
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005-1066
Country
United States
Individual Site Status
Suspended
Facility Name
Dayton Physicians LLC-Atrium
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dayton Physicians LLC-Wayne
City
Greenville
State/Province
Ohio
ZIP/Postal Code
45331
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Wayne Hospital
City
Greenville
State/Province
Ohio
ZIP/Postal Code
45331
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Greater Dayton Cancer Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
First Dayton Cancer Care
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45420
Country
United States
Individual Site Status
Suspended
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mercy Health Perrysburg Cancer Center
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
Individual Site Status
Suspended
Facility Name
Springfield Regional Cancer Center
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45504
Country
United States
Individual Site Status
Suspended
Facility Name
Springfield Regional Medical Center
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Individual Site Status
Suspended
Facility Name
Mercy Health - Saint Anne Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Individual Site Status
Suspended
Facility Name
Toledo Clinic Cancer Centers-Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-444-3561
First Name & Middle Initial & Last Name & Degree
Rex B. Mowat
Facility Name
Dayton Physicians LLC - Troy
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Joseph Warren Hospital
City
Warren
State/Province
Ohio
ZIP/Postal Code
44484
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Saint Elizabeth Youngstown Hospital
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
405-271-8777
Email
ou-clinical-trials@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Sanjay G. Patel
Facility Name
Mercy Hospital Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Alphonsus Medical Center-Baker City
City
Baker City
State/Province
Oregon
ZIP/Postal Code
97814
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Charles Health System
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Individual Site Status
Suspended
Facility Name
Clackamas Radiation Oncology Center
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Individual Site Status
Suspended
Facility Name
Providence Cancer Institute Clackamas Clinic
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Individual Site Status
Suspended
Facility Name
Bay Area Hospital
City
Coos Bay
State/Province
Oregon
ZIP/Postal Code
97420
Country
United States
Individual Site Status
Suspended
Facility Name
Providence Newberg Medical Center
City
Newberg
State/Province
Oregon
ZIP/Postal Code
97132
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Alphonsus Medical Center-Ontario
City
Ontario
State/Province
Oregon
ZIP/Postal Code
97914
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
406-969-6060
Email
mccinfo@mtcancer.org
First Name & Middle Initial & Last Name & Degree
John M. Schallenkamp
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Suspended
Facility Name
Providence Saint Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Suspended
Facility Name
Saint Charles Health System-Redmond
City
Redmond
State/Province
Oregon
ZIP/Postal Code
97756
Country
United States
Individual Site Status
Suspended
Facility Name
Lehigh Valley Hospital-Cedar Crest
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
610-402-9543
Email
Morgan_M.Horton@lvhn.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Lehigh Valley Hospital - Muhlenberg
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
610-402-9543
Email
Morgan_M.Horton@lvhn.org
First Name & Middle Initial & Last Name & Degree
Tareq Al Baghdadi
Facility Name
Pocono Medical Center
City
East Stroudsburg
State/Province
Pennsylvania
ZIP/Postal Code
18301
Country
United States
Individual Site Status
Suspended
Facility Name
Lehigh Valley Hospital-Hazleton
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Individual Site Status
Suspended
Facility Name
Ralph H Johnson VA Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Individual Site Status
Suspended
Facility Name
Gibbs Cancer Center-Gaffney
City
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29341
Country
United States
Individual Site Status
Suspended
Facility Name
Gibbs Cancer Center-Pelham
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
864-560-6104
Email
kmertz-rivera@gibbscc.org
First Name & Middle Initial & Last Name & Degree
Michael Humeniuk
Facility Name
North Grove Medical Park
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Individual Site Status
Suspended
Facility Name
Spartanburg Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
864-560-6104
Email
kmertz-rivera@gibbscc.org
First Name & Middle Initial & Last Name & Degree
Michael Humeniuk
Facility Name
Spartanburg Medical Center - Mary Black Campus
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29307
Country
United States
Individual Site Status
Suspended
Facility Name
MGC Hematology Oncology-Union
City
Union
State/Province
South Carolina
ZIP/Postal Code
29379
Country
United States
Individual Site Status
Suspended
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0565
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
713-798-1354
Email
burton@bcm.edu
First Name & Middle Initial & Last Name & Degree
Seth P. Lerner
Facility Name
UTMB Cancer Center at Victory Lakes
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Audie L Murphy VA Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-469-5300
First Name & Middle Initial & Last Name & Degree
Paromita Datta
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
210-450-3800
Email
phoresearchoffice@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Daruka Mahadevan
Facility Name
American Fork Hospital / Huntsman Intermountain Cancer Center
City
American Fork
State/Province
Utah
ZIP/Postal Code
84003
Country
United States
Individual Site Status
Suspended
Facility Name
Sandra L Maxwell Cancer Center
City
Cedar City
State/Province
Utah
ZIP/Postal Code
84720
Country
United States
Individual Site Status
Suspended
Facility Name
Logan Regional Hospital
City
Logan
State/Province
Utah
ZIP/Postal Code
84321
Country
United States
Individual Site Status
Suspended
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Suspended
Facility Name
McKay-Dee Hospital Center
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Individual Site Status
Suspended
Facility Name
Utah Valley Regional Medical Center
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Individual Site Status
Suspended
Facility Name
Riverton Hospital
City
Riverton
State/Province
Utah
ZIP/Postal Code
84065
Country
United States
Individual Site Status
Suspended
Facility Name
Saint George Regional Medical Center
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Individual Site Status
Suspended
Facility Name
Utah Cancer Specialists-Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Individual Site Status
Suspended
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Individual Site Status
Suspended
Facility Name
Providence Regional Cancer System-Aberdeen
City
Aberdeen
State/Province
Washington
ZIP/Postal Code
98520
Country
United States
Individual Site Status
Suspended
Facility Name
MultiCare Auburn Medical Center
City
Auburn
State/Province
Washington
ZIP/Postal Code
98001
Country
United States
Individual Site Status
Suspended
Facility Name
PeaceHealth Saint Joseph Medical Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Individual Site Status
Suspended
Facility Name
Providence Regional Cancer System-Centralia
City
Centralia
State/Province
Washington
ZIP/Postal Code
98531
Country
United States
Individual Site Status
Suspended
Facility Name
Swedish Cancer Institute-Edmonds
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States
Individual Site Status
Suspended
Facility Name
Providence Regional Cancer Partnership
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Individual Site Status
Suspended
Facility Name
MultiCare Gig Harbor Medical Park
City
Gig Harbor
State/Province
Washington
ZIP/Postal Code
98335
Country
United States
Individual Site Status
Suspended
Facility Name
Swedish Cancer Institute-Issaquah
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98029
Country
United States
Individual Site Status
Suspended
Facility Name
Kadlec Clinic Hematology and Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
509-783-4637
Email
research@kadlecmed.org
First Name & Middle Initial & Last Name & Degree
Alison K. Conlin
Facility Name
Providence Regional Cancer System-Lacey
City
Lacey
State/Province
Washington
ZIP/Postal Code
98503
Country
United States
Individual Site Status
Suspended
Facility Name
PeaceHealth Saint John Medical Center
City
Longview
State/Province
Washington
ZIP/Postal Code
98632
Country
United States
Individual Site Status
Suspended
Facility Name
Jefferson Healthcare
City
Port Townsend
State/Province
Washington
ZIP/Postal Code
98368
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
360-344-3091
First Name & Middle Initial & Last Name & Degree
Nicholas DiBella
Facility Name
MultiCare Good Samaritan Hospital
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States
Individual Site Status
Suspended
Facility Name
Pacific Gynecology Specialists
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Suspended
Facility Name
Swedish Medical Center-Ballard Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98107
Country
United States
Individual Site Status
Suspended
Facility Name
Swedish Medical Center-Cherry Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-5711
Country
United States
Individual Site Status
Suspended
Facility Name
Swedish Medical Center-First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Suspended
Facility Name
PeaceHealth United General Medical Center
City
Sedro-Woolley
State/Province
Washington
ZIP/Postal Code
98284
Country
United States
Individual Site Status
Suspended
Facility Name
Providence Regional Cancer System-Shelton
City
Shelton
State/Province
Washington
ZIP/Postal Code
98584
Country
United States
Individual Site Status
Suspended
Facility Name
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Individual Site Status
Suspended
Facility Name
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Suspended
Facility Name
MultiCare Deaconess Cancer and Blood Specialty Center - North
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Individual Site Status
Suspended
Facility Name
MultiCare Tacoma General Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Suspended
Facility Name
PeaceHealth Southwest Medical Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Individual Site Status
Suspended
Facility Name
Providence Saint Mary Regional Cancer Center
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Individual Site Status
Suspended
Facility Name
Providence Regional Cancer System-Yelm
City
Yelm
State/Province
Washington
ZIP/Postal Code
98597
Country
United States
Individual Site Status
Suspended
Facility Name
Marshfield Medical Center-EC Cancer Center
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-782-8581
Email
oncology.clinical.trials@marshfieldresearch.org
First Name & Middle Initial & Last Name & Degree
Michael Husak
Facility Name
Marshfield Medical Center-Marshfield
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-782-8581
Email
oncology.clinical.trials@marshfieldresearch.org
First Name & Middle Initial & Last Name & Degree
Michael Husak
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
414-805-3666
First Name & Middle Initial & Last Name & Degree
Scott Johnson
Facility Name
Marshfield Clinic-Minocqua Center
City
Minocqua
State/Province
Wisconsin
ZIP/Postal Code
54548
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-782-8581
Email
oncology.clinical.trials@marshfieldresearch.org
First Name & Middle Initial & Last Name & Degree
Michael Husak
Facility Name
ProHealth D N Greenwald Center
City
Mukwonago
State/Province
Wisconsin
ZIP/Postal Code
53149
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
research.institute@phci.org
First Name & Middle Initial & Last Name & Degree
Timothy R. Wassenaar
Facility Name
Cancer Center of Western Wisconsin
City
New Richmond
State/Province
Wisconsin
ZIP/Postal Code
54017
Country
United States
Individual Site Status
Suspended
Facility Name
ProHealth Oconomowoc Memorial Hospital
City
Oconomowoc
State/Province
Wisconsin
ZIP/Postal Code
53066
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
262-928-7878
First Name & Middle Initial & Last Name & Degree
Timothy R. Wassenaar
Facility Name
Marshfield Medical Center-Rice Lake
City
Rice Lake
State/Province
Wisconsin
ZIP/Postal Code
54868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-782-8581
Email
oncology.clinical.trials@marshfieldresearch.org
First Name & Middle Initial & Last Name & Degree
Michael Husak
Facility Name
Marshfield Medical Center-River Region at Stevens Point
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54482
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-782-8581
Email
oncology.clinical.trials@marshfieldresearch.org
First Name & Middle Initial & Last Name & Degree
Michael Husak
Facility Name
ProHealth Waukesha Memorial Hospital
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
262-928-7632
First Name & Middle Initial & Last Name & Degree
Timothy R. Wassenaar
Facility Name
UW Cancer Center at ProHealth Care
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
262-928-5539
Email
Chanda.miller@phci.org
First Name & Middle Initial & Last Name & Degree
Timothy R. Wassenaar
Facility Name
Marshfield Medical Center - Weston
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-782-8581
Email
oncology.clinical.trials@marshfieldresearch.org
First Name & Middle Initial & Last Name & Degree
Michael Husak
Facility Name
Cheyenne Regional Medical Center-West
City
Cheyenne
State/Province
Wyoming
ZIP/Postal Code
82001
Country
United States
Individual Site Status
Suspended
Facility Name
Billings Clinic-Cody
City
Cody
State/Province
Wyoming
ZIP/Postal Code
82414
Country
United States
Individual Site Status
Suspended
Facility Name
Welch Cancer Center
City
Sheridan
State/Province
Wyoming
ZIP/Postal Code
82801
Country
United States
Individual Site Status
Suspended
Facility Name
FHP Health Center-Guam
City
Tamuning
ZIP/Postal Code
96913
Country
Guam
Individual Site Status
Suspended
Facility Name
Cancer Center-Metro Medical Center Bayamon
City
Bayamon
ZIP/Postal Code
00959-5060
Country
Puerto Rico
Individual Site Status
Suspended
Facility Name
HIMA San Pablo Oncologic Hospital
City
Caguas
ZIP/Postal Code
00726
Country
Puerto Rico
Individual Site Status
Suspended
Facility Name
Doctors Cancer Center
City
Manati
ZIP/Postal Code
00674
Country
Puerto Rico
Individual Site Status
Suspended
Facility Name
Instituto Oncologia Moderna Ponce
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Individual Site Status
Suspended
Facility Name
San Juan Community Oncology Group
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Individual Site Status
Suspended
Facility Name
Centro Comprensivo de Cancer de UPR
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Individual Site Status
Suspended
Facility Name
San Juan City Hospital
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
787-763-1296
First Name & Middle Initial & Last Name & Degree
Luis J. Santos Reyes

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
IPD Sharing URL
https://grants.nih.gov/policy/sharing.htm

Learn more about this trial

Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer

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