Testing the Addition of Radiation Therapy to the Usual Immune Therapy Treatment (Atezolizumab) for Extensive Stage Small Cell Lung Cancer, The RAPTOR Trial
Extensive Stage Lung Small Cell Carcinoma
About this trial
This is an interventional treatment trial for Extensive Stage Lung Small Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Any confirmation (cytologic, histologic, or pathologic) of extensive stage small cell lung cancer at any site, either primary or metastases
Partial response (PR) or stable disease (SD) after 4-6 cycles of etoposide/platinum (E/P) doublet plus atezolizumab by re-staging scans (positron emission tomography [PET]/computed tomography [CT] scan, diagnostic CT scan, magnetic resonance imaging [MRI] optional per treating physician); atezolizumab should continue through randomization. Patients must be randomized within 9 weeks of last dose of etoposide/platinum (if not receiving PCI) or 6 weeks from completion of prophylactic cranial irradiation (PCI)
- NOTE: Patients must have at least 3 cycles of E/P plus atezolizumab. They can have one cycle of induction E/P without concurrent atezolizumab if unable to receive concurrent E/P combined with atezolizumab for all cycles of induction therapy
- Patients must have measurable disease (per Response Evaluation Criteria in Solid Tumors [RECIST]) and 3 or fewer observable liver metastases and no evidence of progressive disease (per RECIST) at time of enrollment
- At time of enrollment after induction E/P chemotherapy and atezolizumab, if there is a pleural effusion, patients will be eligible if thoracentesis is cytologically negative or if pleural fluid is too small a volume to effectively sample by thoracentesis and does not show increased metabolic activity on CT/PET imaging
Appropriate stage for study entry based on the following diagnostic workup:
- History/physical examination within 14 days prior to registration;
Imaging within 42 days prior to registration to include:
- MRI brain with contrast or CT brain with contrast
- CT chest, abdomen and pelvis or whole body PET/CT scan any time after the fourth cycle of chemotherapy and prior to registration
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 14 days prior to registration
- Absolute neutrophil count (ANC) >= 1,000/cells/mm^3 (within 14 days prior to registration)
- Platelets >= 75,000 cells/mm^3 (within 14 days prior to registration)
- Hemoglobin >= 8 g/dL (within 14 days prior to registration)
- Total bilirubin =< 1.5 x upper limit of normal (ULN) (within 14 days prior to registration)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x ULN (AST and/or ALT =< 5 ULN for patients with liver involvement) (within 14 days prior to registration)
- Alkaline phosphatase =< 2.5 x ULN (=< 5 ULN for patients with documented liver involvement or bone metastases) (within 14 days prior to registration)
- Adequate renal function = Creatinine clearance >=40 mL/min by the Cockcroft-Gault (C-G) equation: (within 14 days prior to registration)
- Upfront radiation therapy of symptomatic metastatic site is permissible if causing symptoms such as pain or impending fracture
- Patients with brain metastases are eligible after receiving whole brain radiation before enrollment (anytime during induction systemic therapy). Whole brain radiation can be delivered with hippocampal sparing or 3-D conformal technique. Patients with irradiated brain metastases are eligible if they are clinically stable from a neurological standpoint after completing radiotherapy (e.g. not having uncontrolled seizures) and do not require use of steroids above a dose of 10 mg of prednisone daily
For women of childbearing potential, a negative serum or urine pregnancy test within 14 days prior to registration.
Note: Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)
- Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)
- Patients positive for human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months and a stable regimen of highly active anti-retroviral (HAART) HIV-positive patients must have no requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
Exclusion Criteria:
- Metastatic disease invading the liver (> 3 metastases), heart or > 10 metastatic sites detectable after induction systemic therapy. Each visible bone metastasis on radiographic scan counts as one site
- Patients with a concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen with atezolizumab or radiation
- Prior radiotherapy in the thorax that would result in overlapping RT fields, unless the overlapping fields meet acceptable dose constraints for normal tissue
Active autoimmune disease, including, but not limited to: systemic lupus erythematosus; rheumatoid arthritis; inflammatory bowel disease (e.g. Crohn's, ulcerative colitis); vascular thrombosis associated with antiphospholipid syndrome; Wegener's granulomatosis; Sjogren's syndrome; Guillain-Barre syndrome; multiple sclerosis; vasculitis; or glomerulonephritis.
- If the autoimmune disease is not active for over 3 years and the patient is not receiving immunosuppressive treatment such as methotrexate or steroids above a dose equivalent to 10 mg prednisone daily, the patient is eligible.
- Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible
- Patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible
- Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations are excluded only if they have active disease with acute exacerbation and on immunosuppressive medications within the 12 months prior to enrollment. They are eligible otherwise.
Severe, active co-morbidity defined as follows:
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications;
- Active tuberculosis;
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
- Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible
- Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). (The HCV RNA test must be performed for patients who have a positive HCV antibody test)
- Known immunosuppressive disease, for example history of bone marrow transplant or chronic lymphocytic leukemia (CLL);
- Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are not exclusionary;
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months;
- History of recent myocardial infarction within 6 months prior to registration.
- Clinically significant interstitial lung disease
- Pregnancy: Administration of atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and for 5 months (150 days) after the last dose of study agent. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Women who are breastfeeding and unwilling to discontinue
- History of allogeneic organ transplant
- Patients who have had immunotherapy-induced pneumonitis
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Mayo Clinic Hospital in ArizonaRecruiting
- Mayo Clinic in ArizonaRecruiting
- Banner University Medical Center - Tucson
- University of Arizona Cancer Center-North Campus
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - JonesboroRecruiting
- UC Irvine Health/Chao Family Comprehensive Cancer CenterRecruiting
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- UCHealth Memorial Hospital CentralRecruiting
- Memorial Hospital NorthRecruiting
- Poudre Valley HospitalRecruiting
- Cancer Care and Hematology-Fort CollinsRecruiting
- UCHealth Greeley HospitalRecruiting
- Medical Center of the RockiesRecruiting
- Smilow Cancer Hospital Care Center-FairfieldRecruiting
- Smilow Cancer Hospital Care Center at GreenwichRecruiting
- Smilow Cancer Hospital Care Center - GuilfordRecruiting
- Smilow Cancer Hospital-Hamden Care CenterRecruiting
- Yale UniversityRecruiting
- Yale-New Haven Hospital North Haven Medical CenterRecruiting
- Smilow Cancer Hospital Care Center at Long RidgeRecruiting
- Smilow Cancer Hospital Care Center-TrumbullRecruiting
- Smilow Cancer Hospital Care Center - WaterfordRecruiting
- Beebe South Coastal Health CampusRecruiting
- Helen F Graham Cancer CenterRecruiting
- Medical Oncology Hematology Consultants PARecruiting
- Beebe Health CampusRecruiting
- Mount Sinai Comprehensive Cancer Center at Aventura
- UM Sylvester Comprehensive Cancer Center at Coral GablesRecruiting
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachRecruiting
- Mayo Clinic in Florida
- Mount Sinai Medical Center
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Cleveland Clinic-WestonRecruiting
- Grady Health SystemRecruiting
- Emory University Hospital MidtownRecruiting
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Emory Saint Joseph's HospitalRecruiting
- Memorial Health University Medical CenterRecruiting
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Hawaii Cancer Care - Westridge
- Pali Momi Medical Center
- Hawaii Cancer Care Inc - Waterfront Plaza
- Queen's Cancer Cenrer - POB I
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Hawaii Cancer Care Inc-Liliha
- Queen's Cancer Center - Kuakini
- The Cancer Center of Hawaii-Liliha
- Kapiolani Medical Center for Women and Children
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Cancer Care Center-BoiseRecruiting
- Saint Luke's Cancer Institute - BoiseRecruiting
- Saint Alphonsus Cancer Care Center-CaldwellRecruiting
- Saint Luke's Cancer Institute - FruitlandRecruiting
- Saint Luke's Cancer Institute - MeridianRecruiting
- Saint Luke's Cancer Institute - NampaRecruiting
- Saint Alphonsus Cancer Care Center-NampaRecruiting
- Saint Luke's Cancer Institute - Twin FallsRecruiting
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- University of IllinoisRecruiting
- Carle at The RiverfrontRecruiting
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial HospitalRecruiting
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- Elmhurst Memorial HospitalRecruiting
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Edward Hospital/Cancer CenterRecruiting
- Cancer Care Center of O'Fallon
- Illinois CancerCare-Ottawa Clinic
- Illinois CancerCare-Pekin
- Illinois CancerCare-Peoria
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Illinois CancerCare-Princeton
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical CenterRecruiting
- Carle Cancer CenterRecruiting
- The Carle Foundation Hospital
- Illinois CancerCare - Washington
- 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
- Broadlawns Medical CenterRecruiting
- Mercy Medical Center - Des MoinesRecruiting
- Mission Cancer and Blood - LaurelRecruiting
- Iowa Lutheran Hospital
- Methodist West Hospital
- Mercy Medical Center-West LakesRecruiting
- Ascension Via Christi Hospitals WichitaRecruiting
- Norton Hospital Pavilion and Medical CampusRecruiting
- The James Graham Brown Cancer Center at University of LouisvilleRecruiting
- Norton Audubon Hospital and Medical CampusRecruiting
- Norton Brownsboro Hospital and Medical CampusRecruiting
- University of Maryland/Greenebaum Cancer CenterRecruiting
- UM Upper Chesapeake Medical CenterRecruiting
- Central Maryland Radiation Oncology in Howard County
- UM Baltimore Washington Medical Center/Tate Cancer CenterRecruiting
- Boston Medical CenterRecruiting
- Saint Joseph Mercy BrightonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
- Saint Joseph Mercy CantonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - CantonRecruiting
- Saint Joseph Mercy ChelseaRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalRecruiting
- McLaren Cancer Institute-ClarkstonRecruiting
- Wayne State University/Karmanos Cancer InstituteRecruiting
- Weisberg Cancer Treatment CenterRecruiting
- Genesys Hurley Cancer InstituteRecruiting
- Hurley Medical Center
- McLaren Cancer Institute-FlintRecruiting
- Bronson Methodist HospitalRecruiting
- West Michigan Cancer CenterRecruiting
- Borgess Medical Center
- Karmanos Cancer Institute at McLaren Greater LansingRecruiting
- Sparrow HospitalRecruiting
- McLaren Cancer Institute-Lapeer RegionRecruiting
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- MyMichigan Medical Center Midland
- McLaren Cancer Institute-MacombRecruiting
- Ascension Providence Hospitals - NoviRecruiting
- McLaren-Port HuronRecruiting
- William Beaumont Hospital-Royal OakRecruiting
- Ascension Saint Mary's HospitalRecruiting
- Oncology Hematology Associates of Saginaw Valley PCRecruiting
- Ascension Providence Hospitals - SouthfieldRecruiting
- Ascension Saint Joseph HospitalRecruiting
- William Beaumont Hospital - TroyRecruiting
- Saint Mary's Oncology/Hematology Associates of West BranchRecruiting
- Mayo Clinic Health System in Albert LeaRecruiting
- Sanford Joe Lueken Cancer CenterRecruiting
- Saint Luke's Hospital of DuluthRecruiting
- Unity Hospital
- Saint John's Hospital - HealtheastRecruiting
- Abbott-Northwestern HospitalRecruiting
- Mayo Clinic in RochesterRecruiting
- Baptist Memorial Hospital and Cancer Center-DesotoRecruiting
- Saint Francis Medical CenterRecruiting
- MU Health - University Hospital/Ellis Fischel Cancer Center
- Parkland Health Center - FarmingtonRecruiting
- Missouri Baptist Medical CenterRecruiting
- Mercy Hospital Saint LouisRecruiting
- Sainte Genevieve County Memorial HospitalRecruiting
- Missouri Baptist Sullivan HospitalRecruiting
- Missouri Baptist Outpatient Center-Sunset HillsRecruiting
- Bozeman Deaconess HospitalRecruiting
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Nebraska Methodist HospitalRecruiting
- University of Nebraska Medical Center
- Renown Regional Medical CenterRecruiting
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
- Cooper Hospital University Medical Center
- Capital Health Medical Center-HopewellRecruiting
- MD Anderson Cancer Center at Cooper-Voorhees
- Lovelace Medical Center-Saint Joseph SquareRecruiting
- University of New Mexico Cancer CenterRecruiting
- Lovelace Radiation Oncology
- Montefiore Medical Center-Einstein CampusRecruiting
- Montefiore Medical Center-Weiler HospitalRecruiting
- Montefiore Medical Center - Moses CampusRecruiting
- Sands Cancer Center
- Hematology Oncology Associates of Central New York-East SyracuseRecruiting
- Mount Sinai ChelseaRecruiting
- Mount Sinai WestRecruiting
- Mount Sinai HospitalRecruiting
- Wilmot Cancer Institute Radiation Oncology at Greece
- University of Rochester
- State University of New York Upstate Medical UniversityRecruiting
- Hematology Oncology Associates of Central New York-Onondaga HillRecruiting
- Westchester Medical CenterRecruiting
- Atrium Health Stanly/LCI-AlbemarleRecruiting
- Carolinas Medical Center/Levine Cancer InstituteRecruiting
- Atrium Health Pineville/LCI-PinevilleRecruiting
- Levine Cancer Institute-SouthParkRecruiting
- Atrium Health University City/LCI-UniversityRecruiting
- Levine Cancer Institute-BallantyneRecruiting
- Atrium Health Cabarrus/LCI-ConcordRecruiting
- Levine Cancer Institute-GastonRecruiting
- Margaret R Pardee Memorial HospitalRecruiting
- Atrium Health Lincoln/LCI-LincolntonRecruiting
- Atrium Health Union/LCI-UnionRecruiting
- Atrium Health Cleveland/LCI-ClevelandRecruiting
- Wake Forest University Health SciencesRecruiting
- Sanford Bismarck Medical CenterRecruiting
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- Cleveland Clinic Akron GeneralRecruiting
- Aultman Health FoundationRecruiting
- Miami Valley Hospital SouthRecruiting
- University of Cincinnati Cancer Center-UC Medical CenterRecruiting
- MetroHealth Medical CenterRecruiting
- Cleveland Clinic Cancer Center/Fairview HospitalRecruiting
- Cleveland Clinic FoundationRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- Mount Carmel East HospitalRecruiting
- The Mark H Zangmeister CenterRecruiting
- Mount Carmel Health Center WestRecruiting
- Dayton Blood and Cancer CenterRecruiting
- Miami Valley HospitalRecruiting
- Dayton Physician LLC-Miami Valley Hospital NorthRecruiting
- Miami Valley Hospital NorthRecruiting
- Cleveland Clinic Cancer Center IndependenceRecruiting
- Cleveland Clinic Cancer Center MansfieldRecruiting
- Hillcrest Hospital Cancer CenterRecruiting
- North Coast Cancer CareRecruiting
- Cleveland Clinic Cancer Center StrongsvilleRecruiting
- University of Cincinnati Cancer Center-West ChesterRecruiting
- Saint Ann's HospitalRecruiting
- Cleveland Clinic Wooster Family Health and Surgery CenterRecruiting
- Genesis Healthcare System Cancer Care CenterRecruiting
- Cancer Centers of Southwest Oklahoma ResearchRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Mercy Hospital Oklahoma CityRecruiting
- Clackamas Radiation Oncology Center
- Providence Cancer Institute Clackamas ClinicRecruiting
- Legacy Mount Hood Medical CenterRecruiting
- Providence Newberg Medical CenterRecruiting
- Legacy Good Samaritan Hospital and Medical CenterRecruiting
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Legacy Meridian Park HospitalRecruiting
- Crozer-Keystone Regional Cancer Center at BroomallRecruiting
- Bryn Mawr HospitalRecruiting
- Christiana Care Health System-Concord Health CenterRecruiting
- Geisinger Medical CenterRecruiting
- Ephrata Cancer CenterRecruiting
- Saint Vincent Hospital
- Adams Cancer CenterRecruiting
- Penn State Milton S Hershey Medical CenterRecruiting
- Jefferson Hospital
- Sechler Family Cancer CenterRecruiting
- Geisinger Medical Oncology-LewisburgRecruiting
- Riddle Memorial HospitalRecruiting
- Forbes Hospital
- Allegheny Valley Hospital
- Paoli Memorial HospitalRecruiting
- Thomas Jefferson University HospitalRecruiting
- Jefferson Torresdale HospitalRecruiting
- Allegheny General Hospital
- West Penn Hospital
- Guthrie Medical Group PC-Robert Packer HospitalRecruiting
- Wexford Health and Wellness Pavilion
- Geisinger Wyoming Valley/Henry Cancer CenterRecruiting
- Lankenau Medical CenterRecruiting
- WellSpan Health-York Cancer CenterRecruiting
- WellSpan Health-York HospitalRecruiting
- Smilow Cancer Hospital Care Center - WesterlyRecruiting
- Saint Joseph's/Candler - Bluffton Campus
- Medical University of South CarolinaRecruiting
- Gibbs Cancer Center-Gaffney
- Saint Francis HospitalRecruiting
- Prisma Health Cancer Institute - Faris
- Saint Francis Cancer CenterRecruiting
- Prisma Health Cancer Institute - Eastside
- Self Regional HealthcareRecruiting
- Prisma Health Cancer Institute - Greer
- Gibbs Cancer Center-PelhamRecruiting
- Rock Hill Radiation Therapy CenterRecruiting
- Levine Cancer Institute-Rock HillRecruiting
- Prisma Health Cancer Institute - Seneca
- Spartanburg Medical CenterRecruiting
- MGC Hematology Oncology-Union
- Avera Cancer Institute at PierreRecruiting
- Sanford Cancer Center Oncology ClinicRecruiting
- Avera Cancer InstituteRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- Avera Cancer Institute at YanktonRecruiting
- Baptist Memorial Hospital and Cancer Center-MemphisRecruiting
- MD Anderson in The WoodlandsRecruiting
- Texas Oncology-Flower MoundRecruiting
- Texas Oncology - Fort Worth Cancer CenterRecruiting
- M D Anderson Cancer CenterRecruiting
- MD Anderson West HoustonRecruiting
- MD Anderson League CityRecruiting
- Texas Oncology-McKinneyRecruiting
- Texas Oncology-Plano WestRecruiting
- MD Anderson in Sugar LandRecruiting
- Texas Oncology Cancer Center Sugar LandRecruiting
- Texas Oncology-The WoodlandsRecruiting
- Farmington Health Center
- University of Utah Sugarhouse Health Center
- Huntsman Cancer Institute/University of UtahRecruiting
- University of Vermont Medical CenterRecruiting
- University of Vermont and State Agricultural CollegeRecruiting
- Norris Cotton Cancer Center-NorthRecruiting
- Inova Schar Cancer InstituteRecruiting
- VCU Massey Cancer Center at Stony PointRecruiting
- Virginia Commonwealth University/Massey Cancer CenterRecruiting
- Oncology and Hematology Associates of Southwest VirginiaRecruiting
- PeaceHealth Saint Joseph Medical Center
- Harrison Medical CenterRecruiting
- Legacy Cancer Institute Medical Oncology and Day TreatmentRecruiting
- Legacy Salmon Creek HospitalRecruiting
- Wheeling Hospital/Schiffler Cancer CenterRecruiting
- Langlade Hospital and Cancer CenterRecruiting
- Marshfield Medical Center-EC Cancer CenterRecruiting
- Gundersen Lutheran Medical CenterRecruiting
- Mayo Clinic Health System-Franciscan HealthcareRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Froedtert Menomonee Falls HospitalRecruiting
- Medical College of WisconsinRecruiting
- Marshfield Clinic-Minocqua CenterRecruiting
- Drexel Town Square Health CenterRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- Ascension Saint Michael's HospitalRecruiting
- Marshfield Medical Center-River Region at Stevens PointRecruiting
- Aspirus Regional Cancer CenterRecruiting
- Froedtert West Bend Hospital/Kraemer Cancer CenterRecruiting
- Marshfield Medical Center - WestonRecruiting
- Aspirus Cancer Care - Wisconsin RapidsRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (atezolizumab)
Arm II (atezolizumab, radiation therapy)
Patients receive atezolizumab IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT scan, CT, and MRI throughout the trial. Patients also undergo blood and tissue collection throughout the trial.
Patients receive atezolizumab IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy QD on days 1-5 during weeks 1-5 only. Patients undergo PET/CT scan, CT, and MRI throughout the trial. Patients also undergo blood and tissue collection throughout the trial.