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Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers

Primary Purpose

Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Atezolizumab
Bevacizumab
Biospecimen Collection
Carboplatin
Cetuximab
Cisplatin
Computed Tomography
Docetaxel
Echocardiography
Magnetic Resonance Imaging
Positron Emission Tomography
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Eligibility Criteria

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

Inclusion Criteria:

  • Patient must have histologically confirmed squamous cell carcinoma of the head and neck (HNSCC) (excluding SCC of salivary glands, and skin)
  • Patient must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Measurements must be obtained within 4 weeks prior to randomization
  • Patient must be >= 18 years of age
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Patient must have received prior therapy with an immune checkpoint inhibitor (ICI) in the first-line setting for recurrent/metastatic disease with at least stable disease for at least 12 weeks by RECIST. Prior combination immunotherapies are permitted, but patient must not have had any prior chemotherapy, cetuximab or any prior antiangiogenic treatment (e.g., bevacizumab, ziv-aflibercept, ramucirumab, sorafenib, sunitinib, pazopanib, regorafenib, lenvatinib, etc.). Patient must have completed any prior investigational therapy at least 28 days prior to randomization

    • NOTE: Patients who received chemotherapy or cetuximab in combination with radiation for curative-intent treatment of locally-advanced disease and did not progress for at least 6 months thereafter, will not be excluded
  • Patient must have PD-L1 expression >= 1% by CPS in the tumor and/or immune cells

    • NOTE: Enrolling centers should test for PD-L1 CPS preferably using the SP263 assay. Where this is not feasible, any using their preferred Clinical Laboratory Improvement Act (CLIA)-certified assay will be accepted. It is preferred for standard of care (SOC) PD-L1 assessments to be done on post-first line ICI samples if available, but SOC PD-L1 assessments on pre-ICI samples will be accepted for eligibility
  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
  • Leukocytes >= 3,000/mcL (must be obtained =< 14 days prior to protocol randomization)
  • Absolute neutrophil count (ANC) >= 1,500/mcL (must be obtained =< 14 days prior to protocol randomization)
  • Platelets >= 100,000/mcL (must be obtained =< 14 days prior to protocol randomization)
  • Hemoglobin (Hgb) > 9 g/dL (must be obtained =< 14 days prior to protocol randomization) (Note: Patient may be transfused to meet this criteria)
  • Total bilirubin =< 2.0 x institutional upper limit of normal (ULN) (=< 5.0 x institutional ULN if hepatic metastases present or =< 3 x ULN for patients with known Gilbert's disease) (must be obtained =< 14 days prior to protocol randomization)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (< 5.0 x institutional ULN if hepatic metastases present) (must be obtained =< 14 days prior to protocol randomization)
  • Alkaline phosphatase < 2.5 x institutional ULN (< 5.0 x institutional ULN if hepatic or bone metastases present) (must be obtained =< 14 days prior to protocol randomization)
  • Creatinine =< 1.5 x institutional ULN (must be obtained =< 14 days prior to protocol randomization)
  • Patients with uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL or corrected serum calcium > ULN) must have their calcium levels corrected prior to randomization
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. Patients must not have untreated brain metastases or leptomeningeal disease
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

Exclusion Criteria:

  • Patient must not have a history of >= grade 3 immune-related adverse event on prior ICI therapy. Patients who developed grade 3 endocrinopathies but are now stable on hormone supplementation and/or a daily prednisone dose of =< 10 mg (or equivalent doses of another glucocorticoid), will be permitted on this trial
  • Patient must not have a history of PD-1 inhibitor-induced hyper-progression, defined as 100% increase in tumor burden within 8 weeks (or 50% within 4 weeks) of initiating ICI and associated with clinical deterioration
  • Patient must not have any of the following criteria due to the possibility of increased risk for tumor bleeding with bevacizumab therapy:

    • Prior carotid bleeding,
    • Tumors that invade major vessels (e.g., the carotid) as shown unequivocally by imaging studies,
    • Central (e.g., within 2 cm from the hilum) lung metastases that are cavitary as shown unequivocally by imaging studies,
    • Any prior history of bleeding related to the current head and neck cancer,
    • History of gross hemoptysis (bright red blood of 1/2 teaspoon or more per episode of coughing) within 3 months prior to randomization
  • Patient must not have uncontrolled hypertension, a history of hypertensive crisis or hypertensive encephalopathy, or a history of grade 4 thromboembolism
  • Patient must not have a history of coagulopathy or hemorrhagic disorders
  • Patient must not have a history of thrombosis (e.g., pulmonary embolism or deep venous thrombosis) currently requiring therapeutic anticoagulation (prophylactic use of anticoagulation is allowed)
  • Patient must not be receiving chronic daily treatment with aspirin (> 325 mg/day) or non-steroidal anti-inflammatory agents (NSAID's) known to inhibit platelet function. The use of anti-platelet agents [e.g., dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix)] is allowed only if patient is not receiving aspirin or NSAID's known to inhibit platelet function. The use of direct oral anticoagulant therapies such as dabigatran (Pradaxa) and rivaroxaban (Xarelto) is not allowed while on study due to bleeding risk
  • Patient must not have a severe infection within 4 weeks prior to randomization, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. Patients must not have active tuberculosis
  • Patient must not have a history of non-infectious pneumonitis requiring steroids at doses greater than or equal to 10 mg per day of prednisone or the equivalent on first line immunotherapy
  • Patient must not have a history of solid organ transplantation or stem-cell transplant
  • Patient must not be on immunosuppressive medication within 7 days prior to randomization except for: intranasal, inhaled, or topical steroids, local steroid injection, systemic corticosteroids at doses less than or equal to 10 mg per day of prednisone or the equivalent, or steroids used as premedication for hypersensitivity reactions
  • Patient must not have an active autoimmune disease that requires systemic treatment within 2 years prior to randomization. Patients who are receiving replacement therapy for adrenal or pituitary insufficiency will not be excluded
  • Patient must not have had a severe hypersensitivity reaction to any of the drug components used on this protocol or to chimeric or humanized antibodies or fusion proteins
  • Patient must not have received any live vaccine within 30 days prior to randomization and while participating in the study (and continue for 5 months after the last dose of atezolizumab on Arm C). Live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Patients are permitted to receive inactivated vaccines and any non-live vaccines including those for the seasonal influenza and COVID-19 (Note: intranasal influenza vaccines, such as Flu-Mist are live attenuated vaccines and are not allowed). If possible, it is recommended to separate study drug administration from vaccine administration by about a week (primarily, in order to minimize an overlap of adverse events
  • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.

    • All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy.
    • A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 2 months after the last dose of treatment for patients assigned to Arm A and for 6 months after the last dose of protocol treatment for patients assigned to Arms B or C.

    • NOTE: Patients must also not breastfeed while on treatment and for 2 months after the last dose of treatment for patients assigned to Arm A and for 6 months after the last dose of treatment for patients assigned to Arms B or C
  • Patients must not have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients may have indwelling catheters (e.g., PleurX)
  • Patient must not have significant cardiovascular disease (such as New York Heart Association class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to randomization, or unstable arrhythmia or unstable angina at the time of randomization
  • Patient must not receive any other chemotherapy, immunotherapy, antitumor hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy, or experimental medications while on protocol treatment. Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to randomization and patients must be recovered from the effects of radiation (there is no required minimum recovery period
  • Patient must not have had a surgical procedure (including open biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) or significant traumatic injury within 28 days prior to randomization, or anticipation of need for major surgical procedure while on protocol treatment
  • Patient must not have any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of the agents used in this protocol, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
  • Patient must not have a history of abdominal fistula, gastrointestinal (GI) perforation, intra-abdominal abscess, or active GI bleeding within 6 months prior to randomization

Sites / Locations

  • University of Arkansas for Medical SciencesRecruiting
  • Epic Care-DublinRecruiting
  • Epic Care Partners in Cancer CareRecruiting
  • Contra Costa Regional Medical CenterRecruiting
  • Stanford Cancer Institute Palo AltoRecruiting
  • VA Palo Alto Health Care SystemRecruiting
  • Smilow Cancer Hospital-Derby Care CenterRecruiting
  • Smilow Cancer Hospital Care Center-FairfieldRecruiting
  • Smilow Cancer Hospital Care Center at GlastonburyRecruiting
  • Smilow Cancer Hospital Care Center at GreenwichRecruiting
  • Smilow Cancer Hospital Care Center - GuilfordRecruiting
  • Smilow Cancer Hospital Care Center at Saint FrancisRecruiting
  • Yale UniversityRecruiting
  • Yale-New Haven Hospital North Haven Medical CenterRecruiting
  • Smilow Cancer Hospital-Orange Care CenterRecruiting
  • Smilow Cancer Hospital Care Center at Long RidgeRecruiting
  • Smilow Cancer Hospital-Torrington Care CenterRecruiting
  • Smilow Cancer Hospital Care Center-TrumbullRecruiting
  • Smilow Cancer Hospital-Waterbury Care CenterRecruiting
  • Smilow Cancer Hospital Care Center - WaterfordRecruiting
  • Helen F Graham Cancer CenterRecruiting
  • Medical Oncology Hematology Consultants PARecruiting
  • MedStar Washington Hospital CenterRecruiting
  • Broward Health Medical CenterRecruiting
  • Emory University Hospital MidtownRecruiting
  • Emory University Hospital/Winship Cancer InstituteRecruiting
  • Hawaii Cancer Care - WestridgeRecruiting
  • Hawaii Cancer Care Inc - Waterfront PlazaRecruiting
  • Queen's Cancer Cenrer - POB IRecruiting
  • Queen's Medical CenterRecruiting
  • Queen's Cancer Center - KuakiniRecruiting
  • Saint Luke's Cancer Institute - BoiseRecruiting
  • Saint Luke's Cancer Institute - FruitlandRecruiting
  • Saint Luke's Cancer Institute - MeridianRecruiting
  • Saint Luke's Cancer Institute - NampaRecruiting
  • Saint Luke's Cancer Institute - Twin FallsRecruiting
  • Rush - Copley Medical CenterRecruiting
  • John H Stroger Jr Hospital of Cook CountyRecruiting
  • University of IllinoisRecruiting
  • University of Chicago Comprehensive Cancer CenterRecruiting
  • Carle at The RiverfrontRecruiting
  • Carle Physician Group-EffinghamRecruiting
  • Carle Physician Group-Mattoon/CharlestonRecruiting
  • UC Comprehensive Cancer Center at Silver CrossRecruiting
  • University of Chicago Medicine-Orland ParkRecruiting
  • Carle Cancer CenterRecruiting
  • Rush-Copley Healthcare CenterRecruiting
  • Mary Greeley Medical CenterRecruiting
  • McFarland Clinic - AmesRecruiting
  • McFarland Clinic - BooneRecruiting
  • Medical Oncology and Hematology Associates-West Des MoinesRecruiting
  • Mercy Cancer Center-West LakesRecruiting
  • Greater Regional Medical CenterRecruiting
  • Iowa Methodist Medical CenterRecruiting
  • Medical Oncology and Hematology Associates-Des MoinesRecruiting
  • Mercy Medical Center - Des MoinesRecruiting
  • Mission Cancer and Blood - LaurelRecruiting
  • McFarland Clinic - Trinity Cancer CenterRecruiting
  • McFarland Clinic - JeffersonRecruiting
  • McFarland Clinic - MarshalltownRecruiting
  • Mercy Medical Center-West LakesRecruiting
  • Johns Hopkins University/Sidney Kimmel Cancer CenterRecruiting
  • UPMC Western MarylandRecruiting
  • UMass Memorial Medical Center - University Campus
  • Abbott-Northwestern HospitalRecruiting
  • Park Nicollet Clinic - Saint Louis ParkRecruiting
  • Regions HospitalRecruiting
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
  • University of New Mexico Cancer CenterRecruiting
  • Memorial Medical Center - Las CrucesRecruiting
  • Southeastern Medical Oncology Center-ClintonRecruiting
  • Southeastern Medical Oncology Center-GoldsboroRecruiting
  • Southeastern Medical Oncology Center-JacksonvilleRecruiting
  • Miami Valley Hospital SouthRecruiting
  • Dayton Blood and Cancer CenterRecruiting
  • Miami Valley HospitalRecruiting
  • Dayton Physician LLC-Miami Valley Hospital NorthRecruiting
  • Miami Valley Hospital NorthRecruiting
  • Atrium Medical Center-Middletown Regional HospitalRecruiting
  • Kettering Medical CenterRecruiting
  • Trinity's Tony Teramana Cancer CenterRecruiting
  • Toledo Clinic Cancer Centers-ToledoRecruiting
  • Upper Valley Medical CenterRecruiting
  • University of Oklahoma Health Sciences CenterRecruiting
  • Providence Cancer Institute Clackamas Clinic
  • Providence Newberg Medical CenterRecruiting
  • Providence Portland Medical CenterRecruiting
  • Providence Saint Vincent Medical CenterRecruiting
  • UPMC AltoonaRecruiting
  • UPMC-Heritage Valley Health System BeaverRecruiting
  • UPMC Hillman Cancer Center at Butler Health SystemRecruiting
  • UPMC Camp HillRecruiting
  • Carlisle Regional Cancer CenterRecruiting
  • UPMC Hillman Cancer Center - Passavant - CranberryRecruiting
  • UPMC Hillman Cancer Center ErieRecruiting
  • UPMC Cancer Center at UPMC HorizonRecruiting
  • UPMC Cancer Centers - Arnold Palmer PavilionRecruiting
  • Oncology Hematology AssociatesRecruiting
  • UPMC Hillman Cancer Center in Greenville/UPMC Horizon
  • UPMC Pinnacle Cancer Center/Community Osteopathic CampusRecruiting
  • IRMC Cancer CenterRecruiting
  • UPMC-Johnstown/John P. Murtha Regional Cancer CenterRecruiting
  • UPMC Cancer Center at UPMC McKeesportRecruiting
  • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer PavilionRecruiting
  • UPMC Hillman Cancer Center - MonroevilleRecruiting
  • UPMC Hillman Cancer Center in CoraopolisRecruiting
  • UPMC Hillman Cancer Center - Part of Frick HospitalRecruiting
  • Arnold Palmer Cancer Center Medical Oncology NorwinRecruiting
  • UPMC Cancer Center-Natrona HeightsRecruiting
  • UPMC Hillman Cancer Center - New CastleRecruiting
  • ECOG-ACRIN Cancer Research GroupRecruiting
  • Thomas Jefferson University HospitalRecruiting
  • Jefferson Torresdale HospitalRecruiting
  • Allegheny General HospitalRecruiting
  • UPMC-Saint MargaretRecruiting
  • UPMC-Mercy HospitalRecruiting
  • University of Pittsburgh Cancer Institute (UPCI)Recruiting
  • UPMC-Passavant HospitalRecruiting
  • UPMC-Saint Clair Hospital Cancer CenterRecruiting
  • UPMC Cancer Center at UPMC NorthwestRecruiting
  • UPMC Cancer Center-UniontownRecruiting
  • UPMC Cancer Center-WashingtonRecruiting
  • UPMC West Mifflin-Cancer Center JeffersonRecruiting
  • Divine Providence HospitalRecruiting
  • Asplundh Cancer PavilionRecruiting
  • UPMC MemorialRecruiting
  • Smilow Cancer Hospital Care Center - WesterlyRecruiting
  • Thompson Cancer Survival Center
  • Thompson Cancer Survival Center - West
  • Thompson Oncology Group-Lenoir City
  • Vanderbilt University/Ingram Cancer CenterRecruiting
  • Thompson Oncology Group-Oak Ridge
  • Norris Cotton Cancer Center-NorthRecruiting
  • ProHealth D N Greenwald CenterRecruiting
  • ProHealth Oconomowoc Memorial HospitalRecruiting
  • UW Cancer Center at ProHealth CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Phase II, Arm A (Cetuximab, Docetaxel, Cisplatin, Carboplatin)

Phase II, Arm B(Docetaxel, Cisplatin/Carboplatin, Bevacizumab)

Phase II, Arm C (Bevacizumab, Atezolizumab)

Phase III, Arm A (Cetuximab, Docetaxel, Cisplatin/Carboplatin)

Phase III, Arm B (Chemotherapy, Bevacizumab, Atezolizumab)

Arm Description

Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 of each cycle, docetaxel IV over 1 hour on day 1 or days 1 and 8 of each cycle, and cisplatin IV or carboplatin IV on day 1 or days 1 and 8 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 or days 1 and 15 of each cycle of maintenance therapy. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, a PET scan, and/or MRI throughout the trial. Patients may undergo ECHO during screening. Patients undergo blood sample collection throughout the study.

Patients receive bevacizumab IV over 30-90 minutes on day 1 of each cycle, docetaxel IV over 1 hour on day 1 or days 1 and 8 of each cycle, and cisplatin IV or carboplatin IV on day 1 or days 1 and 8 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-60 minutes on day 1 of each cycle of maintenance therapy. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, a PET scan, and/or MRI throughout the trial. Patients may undergo ECHO during screening. Patients undergo blood sample collection throughout the study.

Patients receive bevacizumab IV over 30-90 minutes on day 1 and atezolizumab over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, a PET scan, and/or MRI throughout the trial. Patients may undergo ECHO during screening. Patients undergo blood sample collection throughout the study.

Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 of each cycle, docetaxel IV over 1 hour on day 1 or days 1 and 8 of each cycle, and cisplatin IV or carboplatin IV on day 1 or days 1 and 8 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 or days 1 and 15 of each cycle of maintenance therapy. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, a PET scan, and/or MRI throughout the trial. Patients may undergo ECHO during screening. Patients undergo blood sample collection throughout the study.

Patients receive treatment as in Arm B or C above based on results of the Phase II trial.

Outcomes

Primary Outcome Measures

Progression free survival (PFS) (Phase II)
Overall survival (OS) (Phase III)
Will be compared using a stratified log rank test.

Secondary Outcome Measures

OS in the subset of patients with high PD-L1 expression (Phase III)
The interaction of PD-L1 by treatment will also be evaluated in a Cox proportional hazards model.
Incidence of adverse events (Phase III)
Correlation between fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET) and computed tomography (CT) neck imaging biomarkers
The two-sample t-test will be used to compare the difference of baseline 18F -FDG PET /CT imaging biomarkers (maximum standardized uptake value [SUVmax], metabolic tumor volume [MTV], total lesion glycolysis [TLG], tumor volume) between low and high expression of PD-L1.
Prediction of treatment response
Determined by 18FDG-PET/CT and CT neck imaging biomarkers. To determine if 18FDG-PET/CT and CT neck imaging biomarkers at baseline will predict treatment response at nine to twelve weeks post-treatment, PFS, and OS Logistic regression model will be fit to assess the association of the 18F -FDG PET /CT imaging biomarkers (e.g., SUVmax, MTV, TLG, tumor heterogeneity, tumor volume) with binary treatment response at 9-12 weeks post treatment. Cox proportional hazards models will be fit to assess the association of 18F -FDG PET /CT imaging biomarkers with time-to-event outcomes (PFS or OS).

Full Information

First Posted
September 30, 2021
Last Updated
October 21, 2023
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05063552
Brief Title
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Official Title
A Phase II/III Trial of Chemotherapy + Cetuximab vs Chemotherapy + Bevacizumab vs Atezolizumab + Bevacizumab Following Progression on Immune Checkpoint Inhibition in Recurrent/Metastatic Head and Neck Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
December 15, 2027 (Anticipated)
Study Completion Date
December 15, 2027 (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/III compares the standard therapy (chemotherapy plus cetuximab) versus adding bevacizumab to standard chemotherapy, versus combination of just bevacizumab and atezolizumab in treating patients with head and neck cancer that has spread to other places in the body (metastatic or advanced stage) or has come back after prior treatment (recurrent). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Cisplatin and carboplatin are in a class of chemotherapy medications known as platinum-containing compounds. They work by killing, stopping, or slowing the growth of cancer cells. Docetaxel is in a class of chemotherapy medications called taxanes. It stops cancer cells from growing and dividing and may kill them. The addition of bevacizumab to standard chemotherapy or combination therapy with bevacizumab and atezolizumab may be better than standard chemotherapy plus cetuximab in treating patients with recurrent/metastatic head and neck cancers.
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate progression-free survival (PFS) of patients treated with chemotherapy plus cetuximab, chemotherapy plus bevacizumab, and atezolizumab plus bevacizumab. (Phase II) II. To evaluate the overall survival (OS) of patients treated with chemotherapy plus cetuximab to the superior arm from the phase II portion of the protocol. (Phase III) SECONDARY OBJECTIVES: I. To evaluate the OS for the subset of patients with high PD-L1 expression, defined as combined positive score (CPS) >= 20% on all arms of treatment. II. To evaluate the toxicity of each arm of treatment. IMAGING OBJECTIVES: I. To establish the correlation between fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET) and computed tomography (CT) neck imaging biomarkers (maximum standard uptake value [SUVmax], metabolic tumor volume [MTV], total lesion glycolysis [TLG], tumor volume) and expression of PD-L1 expression (Low versus high, defined as CPS < 20 versus CPS >= 20). II. To determine if 18FDG-PET/CT and CT neck imaging biomarkers at baseline will predict treatment response at nine to twelve weeks post the initiation of treatment, PFS, and OS. EXPLORATORY OBJECTIVE: I. To establish the correlation between 18F-FDG PET and CT neck radiomics features and PD-L1 expressions (Low versus high - defined as CPS < 20 versus CPS >= 20). OUTLINE: This is a randomized phase II trial followed by a randomized phase III trial. PHASE II: Patients are randomized to 1 of 3 arms. ARM A: Patients receive cetuximab intravenously (IV) over 60-120 minutes on days 1, 8, and 15 of each cycle, docetaxel IV over 1 hour on day 1 or days 1 and 8 of each cycle, and cisplatin IV or carboplatin IV on day 1 or days 1 and 8 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 or days 1 and 15 of each cycle of maintenance therapy. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, a PET scan, and/or magnetic resonance imaging (MRI) throughout the trial. Patients may undergo echocardiography (ECHO) during screening. ARM B: Patients receive bevacizumab IV over 30-90 minutes on day 1 of each cycle, docetaxel IV over 1 hour on day 1 or days 1 and 8 of each cycle, and cisplatin IV or carboplatin IV on day 1 or days 1 and 8 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-60 minutes on day 1 of each cycle of maintenance therapy. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, a PET scan, and/or MRI throughout the trial. Patients may undergo ECHO during screening. ARM C: Patients receive bevacizumab IV over 30-90 minutes on day 1 and atezolizumab over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, a PET scan, and/or MRI throughout the trial. Patients may undergo ECHO during screening. PHASE III: Patients are randomized to 1 of 2 arms. ARM A: Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 of each cycle, docetaxel IV over 1 hour on day 1 or days 1 and 8 of each cycle, and cisplatin IV or carboplatin IV on day 1 or days 1 and 8 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 or days 1 and 15 of each cycle of maintenance therapy. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, a PET scan, and/or MRI throughout the trial. Patients may undergo ECHO during screening. ARM B: Patients receive treatment as in Arm B or C above based on results of the Phase II trial. Patients undergo blood sample collection throughout the study. After completion of study treatment, patients are followed up at 30 days and then every 3 months if patient is < 2 years from randomization and every 6 months if patient is 2-5 years from randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma, Metastatic Laryngeal Squamous Cell Carcinoma, Metastatic Lip and Oral Cavity Carcinoma, Metastatic Nasal Cavity Squamous Cell Carcinoma, Metastatic Nasopharyngeal Squamous Cell Carcinoma, Metastatic Pharyngeal Squamous Cell Carcinoma, Metastatic Sinonasal Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Lip and Oral Cavity Squamous Cell Carcinoma, Recurrent Nasopharyngeal Squamous Cell Carcinoma, Recurrent Pharyngeal Squamous Cell Carcinoma, Recurrent Sinonasal Squamous Cell Carcinoma, Stage IV Hypopharyngeal Carcinoma AJCC v8, Stage IV Laryngeal Cancer AJCC v8, Stage IV Lip and Oral Cavity Cancer AJCC v8, Stage IV Nasopharyngeal Carcinoma AJCC v8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IV Sinonasal Cancer AJCC v8

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
430 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase II, Arm A (Cetuximab, Docetaxel, Cisplatin, Carboplatin)
Arm Type
Active Comparator
Arm Description
Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 of each cycle, docetaxel IV over 1 hour on day 1 or days 1 and 8 of each cycle, and cisplatin IV or carboplatin IV on day 1 or days 1 and 8 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 or days 1 and 15 of each cycle of maintenance therapy. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, a PET scan, and/or MRI throughout the trial. Patients may undergo ECHO during screening. Patients undergo blood sample collection throughout the study.
Arm Title
Phase II, Arm B(Docetaxel, Cisplatin/Carboplatin, Bevacizumab)
Arm Type
Experimental
Arm Description
Patients receive bevacizumab IV over 30-90 minutes on day 1 of each cycle, docetaxel IV over 1 hour on day 1 or days 1 and 8 of each cycle, and cisplatin IV or carboplatin IV on day 1 or days 1 and 8 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-60 minutes on day 1 of each cycle of maintenance therapy. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, a PET scan, and/or MRI throughout the trial. Patients may undergo ECHO during screening. Patients undergo blood sample collection throughout the study.
Arm Title
Phase II, Arm C (Bevacizumab, Atezolizumab)
Arm Type
Experimental
Arm Description
Patients receive bevacizumab IV over 30-90 minutes on day 1 and atezolizumab over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, a PET scan, and/or MRI throughout the trial. Patients may undergo ECHO during screening. Patients undergo blood sample collection throughout the study.
Arm Title
Phase III, Arm A (Cetuximab, Docetaxel, Cisplatin/Carboplatin)
Arm Type
Experimental
Arm Description
Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 of each cycle, docetaxel IV over 1 hour on day 1 or days 1 and 8 of each cycle, and cisplatin IV or carboplatin IV on day 1 or days 1 and 8 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 or days 1 and 15 of each cycle of maintenance therapy. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, a PET scan, and/or MRI throughout the trial. Patients may undergo ECHO during screening. Patients undergo blood sample collection throughout the study.
Arm Title
Phase III, Arm B (Chemotherapy, Bevacizumab, Atezolizumab)
Arm Type
Experimental
Arm Description
Patients receive treatment as in Arm B or C above based on results of the Phase II trial.
Intervention Type
Biological
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG7446, RO5541267, Tecentriq
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
ABP 215, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF Monoclonal Antibody SIBP04, Anti-VEGF rhuMAb, Avastin, BAT 1706, BAT-1706, BAT1706, BAT1706 Biosimilar, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BAT1706, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar QL1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-adcd, Bevacizumab-awwb, Bevacizumab-bvzr, BP102, BP102 Biosimilar, CT-P16, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Mvasi, MYL-1402O, QL1101, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, SIBP 04, SIBP-04, SIBP04, Vegzelma, Zirabev
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection, Biospecimen Collected, Specimen Collection
Intervention Description
Undergo blood sample collection
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
C225, Cetuximab Biosimilar CDP-1, Cetuximab Biosimilar CMAB009, Cetuximab Biosimilar KL 140, Chimeric Anti-EGFR Monoclonal Antibody, Chimeric MoAb C225, Chimeric Monoclonal Antibody C225, Erbitux, IMC-C225
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo CT scan
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Docecad, RP 56976, RP56976, Taxotere, Taxotere Injection Concentrate
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Echocardiography
Other Intervention Name(s)
EC
Intervention Description
Undergo ECHO
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo MRI
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT
Intervention Description
Undergo PET scan
Primary Outcome Measure Information:
Title
Progression free survival (PFS) (Phase II)
Time Frame
Time from treatment initiation until disease progression or death, assessed up to 5 years from randomization
Title
Overall survival (OS) (Phase III)
Description
Will be compared using a stratified log rank test.
Time Frame
Time from treatment initiation until death from any cause, assessed up to 5 years from randomization
Secondary Outcome Measure Information:
Title
OS in the subset of patients with high PD-L1 expression (Phase III)
Description
The interaction of PD-L1 by treatment will also be evaluated in a Cox proportional hazards model.
Time Frame
Up to 5 years from randomization
Title
Incidence of adverse events (Phase III)
Time Frame
Up to 30 days after completion of treatment
Title
Correlation between fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET) and computed tomography (CT) neck imaging biomarkers
Description
The two-sample t-test will be used to compare the difference of baseline 18F -FDG PET /CT imaging biomarkers (maximum standardized uptake value [SUVmax], metabolic tumor volume [MTV], total lesion glycolysis [TLG], tumor volume) between low and high expression of PD-L1.
Time Frame
Up to 5 years from randomization
Title
Prediction of treatment response
Description
Determined by 18FDG-PET/CT and CT neck imaging biomarkers. To determine if 18FDG-PET/CT and CT neck imaging biomarkers at baseline will predict treatment response at nine to twelve weeks post-treatment, PFS, and OS Logistic regression model will be fit to assess the association of the 18F -FDG PET /CT imaging biomarkers (e.g., SUVmax, MTV, TLG, tumor heterogeneity, tumor volume) with binary treatment response at 9-12 weeks post treatment. Cox proportional hazards models will be fit to assess the association of 18F -FDG PET /CT imaging biomarkers with time-to-event outcomes (PFS or OS).
Time Frame
Baseline up to 12 weeks
Other Pre-specified Outcome Measures:
Title
Correlation between 18F-FDG PET and CT neck radiomics features and expression of PD-L1 expression
Description
The imaging textural features from radiomics analysis will be associated with the dichotomized PD-L1 expressions. First, proper transformation will be applied to the textural features as needed to address the distribution skewness. Second, Pearson or Spearman rank correlations will be calculated between all pairs of textural features to identify highly correlated features. Third, to address overfitting and high collinearity, machine learning techniques (e.g., LASSO or XGBoost) will be employed for feature selection during the association analysis with PD-L1 expressions.
Time Frame
Up to 5 years from randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient must have histologically confirmed squamous cell carcinoma of the head and neck (HNSCC) (excluding SCC of salivary glands, Epstein-Barr virus [EBV]-associated nasopharynx and skin) Patient must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Measurements must be obtained within 4 weeks prior to randomization Patient must be >= 18 years of age Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Patient must have disease progression after prior therapy with an immune checkpoint inhibitor (ICI) in the first-line setting for recurrent/metastatic disease. Patient must have received first-line immune checkpoint inhibition for at least 6 weeks. Patients who have recurred or progressed within 12 weeks of immune checkpoint inhibition administered in the definitive setting for locally advanced disease (for e.g., in the context of a clinical trial) will also be eligible if local therapies are not feasible Prior combination immunotherapies are permitted, but patient must not have had prior antiangiogenic treatment (e.g., bevacizumab, ziv-aflibercept, ramucirumab, sorafenib, sunitinib, pazopanib, regorafenib, lenvatinib, etc.). Patient must have completed any prior investigational therapy at least 28 days prior to randomization. NOTE: Patients who received platinum/taxanes in the locally-advanced or recurrent/metastatic setting and did not progress for at least 4 months thereafter, will be eligible for this study. Patients who received cetuximab in the locally-advanced setting and did not progress for at least 4 months thereafter, will also be eligible for this study Patient must not have a history of >= grade 3 immune-related adverse event on prior ICI therapy (except those that could be managed with steroids [e.g., dermatologic toxicity, asymptomatic elevation of pancreatic enzymes, etc.]) and ICI could eventually be resumed. Patients who developed grade 3 endocrinopathies but are now stable on hormone supplementation and/or a daily prednisone dose of =< 10 mg (or equivalent doses of another glucocorticoid), will be permitted on this trial Patient must not have a history of PD-1 inhibitor-induced hyper-progression, defined as 100% increase in tumor burden within 8 weeks (or 50% within 4 weeks) of initiating ICI and associated with clinical deterioration Patient must not have any of the following criteria due to the possibility of increased risk for tumor bleeding with bevacizumab therapy: Prior carotid bleeding, Tumors that invade major vessels (e.g., the carotid) as shown unequivocally by imaging studies, Central (e.g., within 2 cm from the hilum) lung metastases that are cavitary as shown unequivocally by imaging studies, Any prior history of bleeding related to the current head and neck cancer, History of gross hemoptysis (bright red blood of 1/2 teaspoon or more per episode of coughing) within 3 months prior to randomization Patient must not have uncontrolled hypertension, a history of hypertensive crisis or hypertensive encephalopathy, or a history of grade 4 thromboembolism Patient must not have a history of coagulopathy or hemorrhagic disorders Patient must not have a history of thrombosis (e.g., pulmonary embolism or deep venous thrombosis) currently requiring therapeutic anticoagulation (prophylactic use of anticoagulation is allowed) Patient must not be receiving chronic daily treatment with aspirin (> 325 mg/day) or non-steroidal anti-inflammatory agents (NSAID's) known to inhibit platelet function. The use of anti-platelet agents [e.g., dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix)] is allowed only if patient is not receiving concurrent aspirin or NSAID's known to inhibit platelet function. Patient must have PD-L1 expression >= 1% by combined positive score (CPS) in the tumor and/or immune cells NOTE: Enrolling centers should test for PD-L1 CPS preferably using the SP263 assay. Where this is not feasible, using their preferred Clinical Laboratory Improvement Act (CLIA)-certified or similar assay will be accepted. It is preferred for standard of care (SOC) PD-L1 assessments to be done on post-first line ICI samples if available, but SOC PD-L1 assessments on pre-ICI samples will be accepted for eligibility Patient must not have a severe infection within 4 weeks prior to randomization, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. Patients must not have active tuberculosis Patient must not have a history of non-infectious pneumonitis requiring steroids at doses greater than or equal to 10 mg per day of prednisone or the equivalent on first line immunotherapy Patient must not have a history of solid organ transplantation or stem-cell transplant Patient must not be on immunosuppressive medication within 7 days prior to randomization except for: intranasal, inhaled, or topical steroids, local steroid injection, systemic corticosteroids at doses less than or equal to 10 mg per day of prednisone or the equivalent, or steroids used as premedication for hypersensitivity reactions Patient must not have an active autoimmune disease that requires systemic treatment within 2 years prior to randomization. Patients who are receiving replacement therapy for adrenal or pituitary insufficiency will not be excluded Patient must not have had a severe hypersensitivity reaction to any of the drug components used on this protocol or to chimeric or humanized antibodies or fusion proteins Patient must not have received any live vaccine within 30 days prior to randomization and while participating in the study (and continue for 5 months after the last dose of atezolizumab on Arm C). Live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Patients are permitted to receive inactivated vaccines and any non-live vaccines including those for the seasonal influenza and coronavirus disease 2019 (COVID-19) (Note: intranasal influenza vaccines, such as Flu-Mist (registered trademark) are live attenuated vaccines and are not allowed). If possible, it is recommended to separate study drug administration from vaccine administration by about a week (primarily, in order to minimize an overlap of adverse events Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 2 months after the last dose of treatment for patients assigned to Arm A and for 6 months after the last dose of protocol treatment for patients assigned to Arms B or C. NOTE: Patients must also not breastfeed while on treatment and for 2 months after the last dose of treatment for patients assigned to Arm A and for 6 months after the last dose of treatment for patients assigned to Arms B or C Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible Leukocytes >= 3,000/mcL (must be obtained =< 14 days prior to protocol randomization) Absolute neutrophil count (ANC) >= 1,500/mcL (must be obtained =< 14 days prior to protocol randomization) Platelets >= 100,000/mcL (must be obtained =< 14 days prior to protocol randomization) Hemoglobin (Hgb) > 9 g/dL (must be obtained =< 14 days prior to protocol randomization) (Note: Patient may be transfused to meet this criteria) Total bilirubin =< 2.0 x institutional upper limit of normal (ULN) (=< 5.0 x institutional ULN if hepatic metastases present or =< 3 x ULN for patients with known Gilbert's disease) (must be obtained =< 14 days prior to protocol randomization) Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (< 5.0 x institutional ULN if hepatic metastases present) (must be obtained =< 14 days prior to protocol randomization) Alkaline phosphatase < 2.5 x institutional ULN (< 5.0 x institutional ULN if hepatic or bone metastases present) (must be obtained =< 14 days prior to protocol randomization) Creatinine =< 1.5 x institutional ULN (must be obtained =< 14 days prior to protocol randomization) Patients with uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL or corrected serum calcium > ULN) must have their calcium levels corrected prior to randomization Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. Patients must not have untreated brain metastases or leptomeningeal disease Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial Patients must not have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients may have indwelling catheters (e.g., PleurX [registered trademark]) Patient must not have significant cardiovascular disease (such as New York Heart Association class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to randomization, or unstable arrhythmia or unstable angina at the time of randomization Patient must not receive any other chemotherapy, immunotherapy, antitumor hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy, or experimental medications while on protocol treatment. Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to randomization and patients must be recovered from the effects of radiation (there is no required minimum recovery period Patient must not have had a surgical procedure (including open biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) or significant traumatic injury within 28 days prior to randomization, or anticipation of need for major surgical procedure while on protocol treatment Patient must not have any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of the agents used in this protocol, may affect the interpretation of the results, or may render the patient at high risk from treatment complications Patient must not have a history of abdominal fistula, gastrointestinal (GI) perforation, intra-abdominal abscess, or active GI bleeding within 6 months prior to randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aarti Bhatia
Organizational Affiliation
ECOG-ACRIN Cancer Research Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
501-686-8274
First Name & Middle Initial & Last Name & Degree
Omar T. Atiq
Facility Name
Epic Care-Dublin
City
Dublin
State/Province
California
ZIP/Postal Code
94568
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
925-875-1677
First Name & Middle Initial & Last Name & Degree
Lisa Bailey
Facility Name
Epic Care Partners in Cancer Care
City
Emeryville
State/Province
California
ZIP/Postal Code
94608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
510-629-6682
First Name & Middle Initial & Last Name & Degree
Lisa Bailey
Facility Name
Contra Costa Regional Medical Center
City
Martinez
State/Province
California
ZIP/Postal Code
94553-3156
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
925-957-5400
First Name & Middle Initial & Last Name & Degree
Lisa Bailey
Facility Name
Stanford Cancer Institute Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
650-498-7061
Email
ccto-office@stanford.edu
First Name & Middle Initial & Last Name & Degree
Saad A. Khan
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-455-0057
First Name & Middle Initial & Last Name & Degree
Harlan A. Pinto
Facility Name
Smilow Cancer Hospital-Derby Care Center
City
Derby
State/Province
Connecticut
ZIP/Postal Code
06418
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-785-5702
Email
canceranswers@yale.edu
First Name & Middle Initial & Last Name & Degree
Aarti Bhatia
Facility Name
Smilow Cancer Hospital Care Center-Fairfield
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-785-5702
Email
canceranswers@yale.edu
First Name & Middle Initial & Last Name & Degree
Aarti Bhatia
Facility Name
Smilow Cancer Hospital Care Center at Glastonbury
City
Glastonbury
State/Province
Connecticut
ZIP/Postal Code
06033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-785-5702
Email
canceranswers@yale.edu
First Name & Middle Initial & Last Name & Degree
Aarti Bhatia
Facility Name
Smilow Cancer Hospital Care Center at Greenwich
City
Greenwich
State/Province
Connecticut
ZIP/Postal Code
06830
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-785-5702
Email
canceranswers@yale.edu
First Name & Middle Initial & Last Name & Degree
Aarti Bhatia
Facility Name
Smilow Cancer Hospital Care Center - Guilford
City
Guilford
State/Province
Connecticut
ZIP/Postal Code
06437
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-785-5702
Email
canceranswers@yale.edu
First Name & Middle Initial & Last Name & Degree
Aarti Bhatia
Facility Name
Smilow Cancer Hospital Care Center at Saint Francis
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-785-5702
Email
canceranswers@yale.edu
First Name & Middle Initial & Last Name & Degree
Aarti Bhatia
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-785-5702
Email
canceranswers@yale.edu
First Name & Middle Initial & Last Name & Degree
Aarti Bhatia
Facility Name
Yale-New Haven Hospital North Haven Medical Center
City
North Haven
State/Province
Connecticut
ZIP/Postal Code
06473
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-785-5702
Email
canceranswers@yale.edu
First Name & Middle Initial & Last Name & Degree
Aarti Bhatia
Facility Name
Smilow Cancer Hospital-Orange Care Center
City
Orange
State/Province
Connecticut
ZIP/Postal Code
06477
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-785-5702
Email
canceranswers@yale.edu
First Name & Middle Initial & Last Name & Degree
Aarti Bhatia
Facility Name
Smilow Cancer Hospital Care Center at Long Ridge
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-785-5702
Email
canceranswers@yale.edu
First Name & Middle Initial & Last Name & Degree
Aarti Bhatia
Facility Name
Smilow Cancer Hospital-Torrington Care Center
City
Torrington
State/Province
Connecticut
ZIP/Postal Code
06790
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-785-5702
Email
canceranswers@yale.edu
First Name & Middle Initial & Last Name & Degree
Aarti Bhatia
Facility Name
Smilow Cancer Hospital Care Center-Trumbull
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-785-5702
Email
canceranswers@yale.edu
First Name & Middle Initial & Last Name & Degree
Aarti Bhatia
Facility Name
Smilow Cancer Hospital-Waterbury Care Center
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-785-5702
Email
canceranswers@yale.edu
First Name & Middle Initial & Last Name & Degree
Aarti Bhatia
Facility Name
Smilow Cancer Hospital Care Center - Waterford
City
Waterford
State/Province
Connecticut
ZIP/Postal Code
06385
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-785-5702
Email
canceranswers@yale.edu
First Name & Middle Initial & Last Name & Degree
Aarti Bhatia
Facility Name
Helen F Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-623-4450
Email
lbarone@christianacare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
Medical Oncology Hematology Consultants PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-623-4450
Email
lbarone@christianacare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
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
Irina G. Veytsman
Facility Name
Broward Health Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-651-5572
Email
Allison.bruce@nemours.org
First Name & Middle Initial & Last Name & Degree
Shannon B. Keating
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
888-946-7447
First Name & Middle Initial & Last Name & Degree
Nabil F. Saba
Facility Name
Emory University Hospital/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
404-778-1868
First Name & Middle Initial & Last Name & Degree
Nabil F. Saba
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
Yoshihito Saito
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
Yoshihito Saito
Facility Name
Queen's Cancer Cenrer - POB I
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
808-532-0315
First Name & Middle Initial & Last Name & Degree
Yoshihito Saito
Facility Name
Queen's Medical Center
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
808-545-8548
First Name & Middle Initial & Last Name & Degree
Yoshihito Saito
Facility Name
Queen's Cancer Center - Kuakini
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
808-531-8521
First Name & Middle Initial & Last Name & Degree
Yoshihito Saito
Facility Name
Saint Luke's Cancer Institute - Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
208-381-2774
Email
eslinget@slhs.org
First Name & Middle Initial & Last Name & Degree
Alison K. Conlin
Facility Name
Saint Luke's Cancer Institute - Fruitland
City
Fruitland
State/Province
Idaho
ZIP/Postal Code
83619
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
208-381-2774
Email
eslinget@slhs.org
First Name & Middle Initial & Last Name & Degree
Alison K. Conlin
Facility Name
Saint Luke's Cancer Institute - Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
208-381-2774
Email
eslinget@slhs.org
First Name & Middle Initial & Last Name & Degree
Alison K. Conlin
Facility Name
Saint Luke's Cancer Institute - Nampa
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
208-381-2774
Email
eslinget@slhs.org
First Name & Middle Initial & Last Name & Degree
Alison K. Conlin
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
208-381-2774
Email
eslinget@slhs.org
First Name & Middle Initial & Last Name & Degree
Alison K. Conlin
Facility Name
Rush - Copley Medical Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
630-978-6212
Email
Cancer.Research@rushcopley.com
First Name & Middle Initial & Last Name & Degree
Prem Sobti
Facility Name
John H Stroger Jr Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
312-864-5204
First Name & Middle Initial & Last Name & Degree
Thomas E. Lad
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
312-355-3046
First Name & Middle Initial & Last Name & Degree
Lawrence E. Feldman
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
773-702-8222
Email
cancerclinicaltrials@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Ari J. Rosenberg
Facility Name
Carle at The Riverfront
City
Danville
State/Province
Illinois
ZIP/Postal Code
61832
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-446-5532
Email
Research@Carle.com
First Name & Middle Initial & Last Name & Degree
Prem Sobti
Facility Name
Carle Physician Group-Effingham
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
800-446-5532
Email
Research@carle.com
First Name & Middle Initial & Last Name & Degree
Prem Sobti
Facility Name
Carle Physician Group-Mattoon/Charleston
City
Mattoon
State/Province
Illinois
ZIP/Postal Code
61938
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-446-5532
Email
Research@carle.com
First Name & Middle Initial & Last Name & Degree
Prem Sobti
Facility Name
UC Comprehensive Cancer Center at Silver Cross
City
New Lenox
State/Province
Illinois
ZIP/Postal Code
60451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
773-702-8222
Email
cancerclinicaltrials@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Ari J. Rosenberg
Facility Name
University of Chicago Medicine-Orland Park
City
Orland Park
State/Province
Illinois
ZIP/Postal Code
60462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
773-702-8222
Email
cancerclinicaltrials@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Ari J. Rosenberg
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-446-5532
Email
Research@carle.com
First Name & Middle Initial & Last Name & Degree
Prem Sobti
Facility Name
Rush-Copley Healthcare Center
City
Yorkville
State/Province
Illinois
ZIP/Postal Code
60560
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
630-978-6212
Email
Cancer.Research@rushcopley.com
First Name & Middle Initial & Last Name & Degree
Prem Sobti
Facility Name
Mary Greeley Medical Center
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-956-4132
First Name & Middle Initial & Last Name & Degree
Joseph J. Merchant
Facility Name
McFarland Clinic - Ames
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-239-4734
Email
ksoder@mcfarlandclinic.com
First Name & Middle Initial & Last Name & Degree
Joseph J. Merchant
Facility Name
McFarland Clinic - Boone
City
Boone
State/Province
Iowa
ZIP/Postal Code
50036
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-956-4132
First Name & Middle Initial & Last Name & Degree
Joseph J. Merchant
Facility Name
Medical Oncology and Hematology Associates-West Des Moines
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-241-3305
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
Mercy Cancer Center-West Lakes
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-358-6613
Email
cancerresearch@mercydesmoines.org
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
Greater Regional Medical Center
City
Creston
State/Province
Iowa
ZIP/Postal Code
50801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-358-6613
Email
cancerresearch@mercydesmoines.org
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-241-6727
First Name & Middle Initial & Last Name & Degree
Joshua Lukenbill
Facility Name
Medical Oncology and Hematology Associates-Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-241-3305
First Name & Middle Initial & Last Name & Degree
Joshua Lukenbill
Facility Name
Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-358-6613
Email
cancerresearch@mercydesmoines.org
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
Mission Cancer and Blood - Laurel
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-241-3305
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
McFarland Clinic - Trinity Cancer Center
City
Fort Dodge
State/Province
Iowa
ZIP/Postal Code
50501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-956-4132
First Name & Middle Initial & Last Name & Degree
Joseph J. Merchant
Facility Name
McFarland Clinic - Jefferson
City
Jefferson
State/Province
Iowa
ZIP/Postal Code
50129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-956-4132
First Name & Middle Initial & Last Name & Degree
Joseph J. Merchant
Facility Name
McFarland Clinic - Marshalltown
City
Marshalltown
State/Province
Iowa
ZIP/Postal Code
50158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-956-4132
First Name & Middle Initial & Last Name & Degree
Joseph J. Merchant
Facility Name
Mercy Medical Center-West Lakes
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-358-6613
Email
cancerresearch@mercydesmoines.org
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
Johns Hopkins University/Sidney Kimmel Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
410-955-8804
Email
jhcccro@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Tanguy Y. Seiwert
Facility Name
UPMC Western Maryland
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
240-964-1400
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UMass Memorial Medical Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
952-993-1517
Email
mmcorc@healthpartners.com
First Name & Middle Initial & Last Name & Degree
David M. King
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
952-993-1517
Email
mmcorc@healthpartners.com
First Name & Middle Initial & Last Name & Degree
David M. King
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
952-993-1517
Email
mmcorc@healthpartners.com
First Name & Middle Initial & Last Name & Degree
David M. King
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
Garrett T. Wasp
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
505-925-0348
Email
HSC-ClinicalTrialInfo@salud.unm.edu
First Name & Middle Initial & Last Name & Degree
Martha Mapalo
Facility Name
Memorial Medical Center - Las Cruces
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
575-556-6545
Email
Kim.Hoffman@lpnt.net
First Name & Middle Initial & Last Name & Degree
Martha Mapalo
Facility Name
Southeastern Medical Oncology Center-Clinton
City
Clinton
State/Province
North Carolina
ZIP/Postal Code
28328
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
919-587-9084
Email
jfields@cancersmoc.com
First Name & Middle Initial & Last Name & Degree
Samer S. Kasbari
Facility Name
Southeastern Medical Oncology Center-Goldsboro
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
919-587-9084
Email
jfields@cancersmoc.com
First Name & Middle Initial & Last Name & Degree
Samer S. Kasbari
Facility Name
Southeastern Medical Oncology Center-Jacksonville
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
910-587-9084
Email
jfields@cancersmoc.com
First Name & Middle Initial & Last Name & Degree
Samer S. Kasbari
Facility Name
Miami Valley Hospital South
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
937-528-2900
Email
clinical.trials@daytonncorp.org
First Name & Middle Initial & Last Name & Degree
Tarek M. Sabagh
Facility Name
Dayton Blood and Cancer Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
937-276-8320
First Name & Middle Initial & Last Name & Degree
Tarek M. Sabagh
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
937-528-2900
Email
clinical.trials@daytonncorp.org
First Name & Middle Initial & Last Name & Degree
Tarek M. Sabagh
Facility Name
Dayton Physician LLC-Miami Valley Hospital North
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
937-528-2900
Email
clinical.trials@daytonncorp.org
First Name & Middle Initial & Last Name & Degree
Howard M. Gross
Facility Name
Miami Valley Hospital North
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
937-528-2900
Email
clinical.trials@daytonncorp.org
First Name & Middle Initial & Last Name & Degree
Tarek M. Sabagh
Facility Name
Atrium Medical Center-Middletown Regional Hospital
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005-1066
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
937-528-2900
Email
clinical.trials@daytonncorp.org
First Name & Middle Initial & Last Name & Degree
Tarek M. Sabagh
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
937-528-2900
Email
clinical.trials@daytonncorp.org
First Name & Middle Initial & Last Name & Degree
Howard M. Gross
Facility Name
Trinity's Tony Teramana Cancer Center
City
Steubenville
State/Province
Ohio
ZIP/Postal Code
43952
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
888-874-7000
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
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
Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
937-528-2900
Email
clinical.trials@daytonncorp.org
First Name & Middle Initial & Last Name & Degree
Tarek M. Sabagh
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
Minh Phan
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
Providence Newberg Medical Center
City
Newberg
State/Province
Oregon
ZIP/Postal Code
97132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
503-215-2614
Email
CanRsrchStudies@providence.org
First Name & Middle Initial & Last Name & Degree
Alison K. Conlin
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
503-215-2614
Email
CanRsrchStudies@providence.org
First Name & Middle Initial & Last Name & Degree
Alison K. Conlin
Facility Name
Providence Saint Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
503-215-2614
Email
CanRsrchStudies@providence.org
First Name & Middle Initial & Last Name & Degree
Alison K. Conlin
Facility Name
UPMC Altoona
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
ecog.rss@jimmy.harvard.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC-Heritage Valley Health System Beaver
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Hillman Cancer Center at Butler Health System
City
Butler
State/Province
Pennsylvania
ZIP/Postal Code
16001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Camp Hill
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
717-975-8900
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
Carlisle Regional Cancer Center
City
Carlisle
State/Province
Pennsylvania
ZIP/Postal Code
17015
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
ecog.rss@jimmy.harvard.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Hillman Cancer Center - Passavant - Cranberry
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Hillman Cancer Center Erie
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Cancer Center at UPMC Horizon
City
Farrell
State/Province
Pennsylvania
ZIP/Postal Code
16121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
ecog.rss@jimmy.harvard.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Cancer Centers - Arnold Palmer Pavilion
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
724-838-1900
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
Oncology Hematology Associates
City
Greenville
State/Province
Pennsylvania
ZIP/Postal Code
16125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
ecog.rss@jimmy.harvard.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Hillman Cancer Center in Greenville/UPMC Horizon
City
Greenville
State/Province
Pennsylvania
ZIP/Postal Code
16125
Country
United States
Individual Site Status
Suspended
Facility Name
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
717-724-6765
Email
klitchfield@PINNACLEHEALTH.org
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
IRMC Cancer Center
City
Indiana
State/Province
Pennsylvania
ZIP/Postal Code
15701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC-Johnstown/John P. Murtha Regional Cancer Center
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
814-534-4724
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Cancer Center at UPMC McKeesport
City
McKeesport
State/Province
Pennsylvania
ZIP/Postal Code
15132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-647-8073
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
City
Mechanicsburg
State/Province
Pennsylvania
ZIP/Postal Code
17050
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Hillman Cancer Center - Monroeville
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Hillman Cancer Center in Coraopolis
City
Moon
State/Province
Pennsylvania
ZIP/Postal Code
15108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Hillman Cancer Center - Part of Frick Hospital
City
Mount Pleasant
State/Province
Pennsylvania
ZIP/Postal Code
15666
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
Arnold Palmer Cancer Center Medical Oncology Norwin
City
N. Huntingdon
State/Province
Pennsylvania
ZIP/Postal Code
15642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Cancer Center-Natrona Heights
City
Natrona Heights
State/Province
Pennsylvania
ZIP/Postal Code
15065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
724-230-3030
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Hillman Cancer Center - New Castle
City
New Castle
State/Province
Pennsylvania
ZIP/Postal Code
16105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
ECOG-ACRIN Cancer Research Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aarti Bhatia
Email
aarti.bhatia@yale.edu
First Name & Middle Initial & Last Name & Degree
Aarti Bhatia
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
215-600-9151
Email
ONCTrialNow@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Jennifer M. Johnson
Facility Name
Jefferson Torresdale Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
215-600-9151
Email
ONCTrialNow@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Jennifer M. Johnson
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-284-2000
First Name & Middle Initial & Last Name & Degree
Larisa Greenberg
Facility Name
UPMC-Saint Margaret
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-784-4900
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC-Mercy Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-533-8762
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
University of Pittsburgh Cancer Institute (UPCI)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-647-8073
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC-Passavant Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-367-6454
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC-Saint Clair Hospital Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-502-3920
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Cancer Center at UPMC Northwest
City
Seneca
State/Province
Pennsylvania
ZIP/Postal Code
16346
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
814-676-7900
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Cancer Center-Uniontown
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
ecog.rss@jimmy.harvard.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Cancer Center-Washington
City
Washington
State/Province
Pennsylvania
ZIP/Postal Code
15301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
ecog.rss@jimmy.harvard.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC West Mifflin-Cancer Center Jefferson
City
West Mifflin
State/Province
Pennsylvania
ZIP/Postal Code
15122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-653-8100
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
Divine Providence Hospital
City
Williamsport
State/Province
Pennsylvania
ZIP/Postal Code
17754
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
ecog.rss@jimmy.harvard.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
Asplundh Cancer Pavilion
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
215-600-9151
Email
ONCTrialNow@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Jennifer M. Johnson
Facility Name
UPMC Memorial
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17408
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
717-724-6760
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
Smilow Cancer Hospital Care Center - Westerly
City
Westerly
State/Province
Rhode Island
ZIP/Postal Code
02891
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-785-5702
Email
canceranswers@yale.edu
First Name & Middle Initial & Last Name & Degree
Aarti Bhatia
Facility Name
Thompson Cancer Survival Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Thompson Cancer Survival Center - West
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37932
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Thompson Oncology Group-Lenoir City
City
Lenoir City
State/Province
Tennessee
ZIP/Postal Code
37772
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Vanderbilt University/Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-811-8480
First Name & Middle Initial & Last Name & Degree
Jennifer H. Choe
Facility Name
Thompson Oncology Group-Oak Ridge
City
Oak Ridge
State/Province
Tennessee
ZIP/Postal Code
37830
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Norris Cotton Cancer Center-North
City
Saint Johnsbury
State/Province
Vermont
ZIP/Postal Code
05819
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@hitchcock.org
First Name & Middle Initial & Last Name & Degree
Garrett T. Wasp
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
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
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

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 Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers

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