RECRUITING

Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial

Conditions

Metastatic Renal Cell Carcinoma Stage III Renal Cell Cancer AJCC v8 Stage IV Renal Cell Cancer AJCC v8 Unresectable Renal Cell Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial tests whether the addition of radiation to the primary tumor, typically given with stereotactic ablative radiation therapy (SABR), in combination with standard of care immunotherapy improves outcomes in patients with renal cell cancer that is not recommended for surgery and has spread from where it first started (primary site) to other places in the body (metastatic). Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses of radiation over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, avelumab, and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib, cabozantinib, and lenvatinib are in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving SABR in combination with standard of care immunotherapy may help shrink or stabilize the cancer in patients with renal cell cancer.

Official Title

Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)

Quick Facts

Study Start:2023-02-01

Study Completion:2028-06-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05327686

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Pathologically (histologically or cytologically) proven diagnosis of renal cell carcinoma prior to registration * Node-positive unresectable (TxN1Mx) or metastatic (TxNxM1) based on the following diagnostic workup: * History/physical examination within 45 days prior to registration * CT/magnetic resonance imaging (MRI) of the chest/abdomen/pelvis within 45 days prior to registration * Patients must have IMDC intermediate (1-2 factors) or poor risk disease (\>= 3 factors) * 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 with measurable disease (node positive or metastatic) as defined by RECIST version 1.1 excluding the primary renal tumor * Patient not recommended for or refused immediate cytoreductive nephrectomy * Candidate for standard of care therapy with either immuno-oncology (IO)-IO or IO-VEGF combination regimen * Primary renal tumor measuring 20 cm or less in anterior to posterior dimension only on axial imaging * Age \>= 18 * Karnofsky performance status \>= 60 within 45 days prior to registration * Hemoglobin \>= 8 g/dL (transfusions are allowed) (within 45 days prior to registration) * Platelet count \>= 50,000/mm\^3 (within 45 days prior to registration) * Absolute neutrophil count (ANC) \>= 1500/mm\^3 (within 45 days prior to registration) * Calculated (Calc.) creatinine clearance \>= 30 mL/min (within 45 days prior to registration) * Creatinine clearance (CrCl) \>= 30 mL/min estimated by Cockcroft-Gault Equation * For African American patients specifically whose renal function is not considered adequate by the formula above, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) should be used for calculating the related estimated glomerular filtration rate (GFR) with a correction factor for African American race creatinine clearance for trial eligibility, where GFR \>= 30 mL/min/1.73m\^2 will be considered adequate * Total bilirubin =\< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL) (within 45 days prior to registration) * Aspartate aminotransferase and alanine aminotransferase (AST and ALT) =\< 3 x upper limit of normal (ULN) or \< 5 x ULN if hepatic metastases present (within 45 days prior to registration) * Patients with known human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Testing is not required for entry into protocol * 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. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load * The patient must agree to use a highly effective contraception, including men with vasectomies if they are having sex with a woman of childbearing potential or with a woman who is pregnant, while on study drug and for 6 months following the last dose of study drug. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information	* Patients with planned treatment of all metastatic disease with definitive therapy including either surgery, ablative (non-palliative) doses of radiation, or intervention of some type (definitive interventional radiology techniques) to ALL metastatic sites rendering the patient without extra-renal measurable disease. Patients NOT planned for definitive treatment of all metastatic sites are eligible. Lesions radiated palliatively are not eligible for response assessment * Patients with untreated or unstable brain metastases or cranial epidural disease * Note: Patients who have been adequately treated with radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator are eligible. Treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator * Prior radiotherapy to the kidney that would result in overlap of radiation therapy fields treatment of the primary tumor * Any systemic therapy for metastatic renal cell carcinoma (RCC) that was initiated \> 90 days before registration, note that prior chemotherapy for a different cancer is allowed (completed \> 3 years prior to registration) * Severe, active comorbidity defined as follows: * Active autoimmune disease requiring ongoing therapy including systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications daily. Inhaled steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease * History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies * Active tuberculosis (purified protein derivative \[PPD\] response without active tuberculosis \[TB\] is allowed) * Uncontrolled hypertension (systolic blood pressure \[BP\] \>= 190 mmHg or diastolic BP \> 110 mmHg) * Major surgery requiring hospital admission =\< 28 days prior to registration * Any serious (requiring hospital stay or long term rehab) non-healing wound, ulcer, or bone fracture within 45 days prior to registration * Any arterial thrombotic (ST elevation myocardial infarction \[STEMI\], non-ST elevation myocardial infarction \[NSTEMI\], cerebrovascular accident \[CVA\], etc) events within 180 days prior to registration * Active New York (NY) Heart Association class 3-4 heart failure symptoms * Moderate or severe hepatic impairment (Child-Pugh B or C) * Any history of untreated pulmonary embolism or deep venous thrombosis (DVT) within 180 days prior to registration. (Any asymptomatic or treated pulmonary embolism or asymptomatic treated deep venous thrombosis \> 30 days prior to registration is allowed) * Unstable cardiac arrhythmia within 180 days prior to registration * History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, bowel obstruction, or gastric outlet obstruction within 180 days prior to registration * History of or active inflammatory bowel disease * Malabsorption syndrome within 45 days prior to registration * Pregnancy and individuals unwilling to discontinue nursing. For women of child bearing potential must have a negative pregnancy test =\< 45 days prior to registration

Inclusion Criteria

Exclusion Criteria

* Pathologically (histologically or cytologically) proven diagnosis of renal cell carcinoma prior to registration
* Node-positive unresectable (TxN1Mx) or metastatic (TxNxM1) based on the following diagnostic workup:
* History/physical examination within 45 days prior to registration
* CT/magnetic resonance imaging (MRI) of the chest/abdomen/pelvis within 45 days prior to registration
* Patients must have IMDC intermediate (1-2 factors) or poor risk disease (\>= 3 factors)
* 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 with measurable disease (node positive or metastatic) as defined by RECIST version 1.1 excluding the primary renal tumor
* Patient not recommended for or refused immediate cytoreductive nephrectomy
* Candidate for standard of care therapy with either immuno-oncology (IO)-IO or IO-VEGF combination regimen
* Primary renal tumor measuring 20 cm or less in anterior to posterior dimension only on axial imaging
* Age \>= 18
* Karnofsky performance status \>= 60 within 45 days prior to registration
* Hemoglobin \>= 8 g/dL (transfusions are allowed) (within 45 days prior to registration)
* Platelet count \>= 50,000/mm\^3 (within 45 days prior to registration)
* Absolute neutrophil count (ANC) \>= 1500/mm\^3 (within 45 days prior to registration)
* Calculated (Calc.) creatinine clearance \>= 30 mL/min (within 45 days prior to registration)
* Creatinine clearance (CrCl) \>= 30 mL/min estimated by Cockcroft-Gault Equation
* For African American patients specifically whose renal function is not considered adequate by the formula above, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) should be used for calculating the related estimated glomerular filtration rate (GFR) with a correction factor for African American race creatinine clearance for trial eligibility, where GFR \>= 30 mL/min/1.73m\^2 will be considered adequate
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL) (within 45 days prior to registration)
* Aspartate aminotransferase and alanine aminotransferase (AST and ALT) =\< 3 x upper limit of normal (ULN) or \< 5 x ULN if hepatic metastases present (within 45 days prior to registration)
* Patients with known human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Testing is not required for entry into protocol
* 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. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load
* The patient must agree to use a highly effective contraception, including men with vasectomies if they are having sex with a woman of childbearing potential or with a woman who is pregnant, while on study drug and for 6 months following the last dose of study drug. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

* Patients with planned treatment of all metastatic disease with definitive therapy including either surgery, ablative (non-palliative) doses of radiation, or intervention of some type (definitive interventional radiology techniques) to ALL metastatic sites rendering the patient without extra-renal measurable disease. Patients NOT planned for definitive treatment of all metastatic sites are eligible. Lesions radiated palliatively are not eligible for response assessment
* Patients with untreated or unstable brain metastases or cranial epidural disease
* Note: Patients who have been adequately treated with radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator are eligible. Treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator
* Prior radiotherapy to the kidney that would result in overlap of radiation therapy fields treatment of the primary tumor
* Any systemic therapy for metastatic renal cell carcinoma (RCC) that was initiated \> 90 days before registration, note that prior chemotherapy for a different cancer is allowed (completed \> 3 years prior to registration)
* Severe, active comorbidity defined as follows:
* Active autoimmune disease requiring ongoing therapy including systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications daily. Inhaled steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
* History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies
* Active tuberculosis (purified protein derivative \[PPD\] response without active tuberculosis \[TB\] is allowed)
* Uncontrolled hypertension (systolic blood pressure \[BP\] \>= 190 mmHg or diastolic BP \> 110 mmHg)
* Major surgery requiring hospital admission =\< 28 days prior to registration
* Any serious (requiring hospital stay or long term rehab) non-healing wound, ulcer, or bone fracture within 45 days prior to registration
* Any arterial thrombotic (ST elevation myocardial infarction \[STEMI\], non-ST elevation myocardial infarction \[NSTEMI\], cerebrovascular accident \[CVA\], etc) events within 180 days prior to registration
* Active New York (NY) Heart Association class 3-4 heart failure symptoms
* Moderate or severe hepatic impairment (Child-Pugh B or C)
* Any history of untreated pulmonary embolism or deep venous thrombosis (DVT) within 180 days prior to registration. (Any asymptomatic or treated pulmonary embolism or asymptomatic treated deep venous thrombosis \> 30 days prior to registration is allowed)
* Unstable cardiac arrhythmia within 180 days prior to registration
* History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, bowel obstruction, or gastric outlet obstruction within 180 days prior to registration
* History of or active inflammatory bowel disease
* Malabsorption syndrome within 45 days prior to registration
* Pregnancy and individuals unwilling to discontinue nursing. For women of child bearing potential must have a negative pregnancy test =\< 45 days prior to registration

Contacts and Locations

Principal Investigator

William A Hall

PRINCIPAL_INVESTIGATOR

NRG Oncology

Study Locations (Sites)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

United States

PCR Oncology

Arroyo Grande, California, 93420

United States

Mills-Peninsula Medical Center

Burlingame, California, 94010

United States

City of Hope Comprehensive Cancer Center

Duarte, California, 91010

United States

UC San Diego Health System - Encinitas

Encinitas, California, 92024

United States

UC San Diego Moores Cancer Center

La Jolla, California, 92093

United States

Memorial Medical Center

Modesto, California, 95355

United States

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, 95661

United States

Sutter Roseville Medical Center

Roseville, California, 95661

United States

Sutter Medical Center Sacramento

Sacramento, California, 95816

United States

UC San Diego Medical Center - Hillcrest

San Diego, California, 92103

United States

UCSF Medical Center-Mission Bay

San Francisco, California, 94158

United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, 93401

United States

Mills Health Center

San Mateo, California, 94401

United States

Ridley-Tree Cancer Center

Santa Barbara, California, 93105

United States

Sutter Pacific Medical Foundation

Santa Rosa, California, 95403

United States

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045

United States

UCHealth - Cherry Creek

Denver, Colorado, 80206

United States

Poudre Valley Hospital

Fort Collins, Colorado, 80524

United States

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, 80528

United States

UCHealth Greeley Hospital

Greeley, Colorado, 80631

United States

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, 80129

United States

UCHealth Lone Tree Health Center

Lone Tree, Colorado, 80124

United States

Medical Center of the Rockies

Loveland, Colorado, 80538

United States

Mount Sinai Comprehensive Cancer Center at Aventura

Aventura, Florida, 33180

United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021

United States

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980

United States

Mount Sinai Medical Center

Miami Beach, Florida, 33140

United States

Miami Cancer Institute

Miami, Florida, 33176

United States

Memorial Hospital West

Pembroke Pines, Florida, 33028

United States

Alton Memorial Hospital

Alton, Illinois, 62002

United States

Centralia Oncology Clinic

Centralia, Illinois, 62801

United States

Northwestern University

Chicago, Illinois, 60611

United States

Carle at The Riverfront

Danville, Illinois, 61832

United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526

United States

Decatur Memorial Hospital

Decatur, Illinois, 62526

United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115

United States

Carle Physician Group-Effingham

Effingham, Illinois, 62401

United States

Crossroads Cancer Center

Effingham, Illinois, 62401

United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134

United States

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, 60026

United States

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, 60030

United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938

United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269

United States

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, 62269

United States

UW Health Carbone Cancer Center Rockford

Rockford, Illinois, 61114

United States

Memorial Hospital East

Shiloh, Illinois, 62269

United States

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

United States

Springfield Clinic

Springfield, Illinois, 62702

United States

Springfield Memorial Hospital

Springfield, Illinois, 62781

United States

Carle Cancer Center

Urbana, Illinois, 61801

United States

The Carle Foundation Hospital

Urbana, Illinois, 61801

United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555

United States

Mary Greeley Medical Center

Ames, Iowa, 50010

United States

McFarland Clinic - Ames

Ames, Iowa, 50010

United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023

United States

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, 50325

United States

Iowa Methodist Medical Center

Des Moines, Iowa, 50309

United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309

United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, 50314

United States

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, 50263

United States

Louisiana Hematology Oncology Associates LLC

Baton Rouge, Louisiana, 70809

United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809

United States

Mary Bird Perkins Cancer Center - Metairie

Metairie, Louisiana, 70002

United States

East Jefferson General Hospital

Metairie, Louisiana, 70006

United States

LSU Healthcare Network / Metairie Multi-Specialty Clinic

Metairie, Louisiana, 70006

United States

Louisiana State University Health Science Center

New Orleans, Louisiana, 70112

United States

University Medical Center New Orleans

New Orleans, Louisiana, 70112

United States

Touro Infirmary

New Orleans, Louisiana, 70115

United States

MaineHealth Coastal Cancer Treatment Center

Bath, Maine, 04530

United States

MaineHealth Maine Medical Center - Biddeford

Biddeford, Maine, 04005

United States

MaineHealth Maine Medical Center - Portland

Portland, Maine, 04102

United States

MaineHealth Cancer Care and IV Therapy - Sanford

Sanford, Maine, 04073

United States

MaineHealth Cancer Care Center of York County

Sanford, Maine, 04073

United States

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, 04074

United States

MaineHealth Cancer Care and IV Therapy - South Portland

South Portland, Maine, 04106

United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201

United States

Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, 21044

United States

UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, 21061

United States

Beverly Hospital

Beverly, Massachusetts, 01915

United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805

United States

Addison Gilbert Hospital

Gloucester, Massachusetts, 01930

United States

Lahey Medical Center-Peabody

Peabody, Massachusetts, 01960

United States

Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care

Winchester, Massachusetts, 01890

United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106

United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109

United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114

United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114

United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188

United States

Trinity Health Medical Center - Canton

Canton, Michigan, 48188

United States

Chelsea Hospital

Chelsea, Michigan, 48118

United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118

United States

Corewell Health Dearborn Hospital

Dearborn, Michigan, 48124

United States

Corewell Health Farmington Hills Hospital

Farmington Hills, Michigan, 48336

United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912

United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154

United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073

United States

Corewell Health Beaumont Troy Hospital

Troy, Michigan, 48085

United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197

United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601

United States

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, 56401

United States

Essentia Health - Deer River Clinic

Deer River, Minnesota, 56636

United States

Essentia Health Cancer Center

Duluth, Minnesota, 55805

United States

Essentia Health Saint Mary's Medical Center

Duluth, Minnesota, 55805

United States

Miller-Dwan Hospital

Duluth, Minnesota, 55805

United States

Fairview Southdale Hospital

Edina, Minnesota, 55435

United States

Essentia Health Hibbing Clinic

Hibbing, Minnesota, 55746

United States

Hennepin County Medical Center

Minneapolis, Minnesota, 55415

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Regions Hospital

Saint Paul, Minnesota, 55101

United States

Essentia Health Sandstone

Sandstone, Minnesota, 55072

United States

Lakeview Hospital

Stillwater, Minnesota, 55082

United States

Essentia Health Virginia Clinic

Virginia, Minnesota, 55792

United States

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

United States

MU Health - University Hospital/Ellis Fischel Cancer Center

Columbia, Missouri, 65212

United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Mercy Hospital South

Saint Louis, Missouri, 63128

United States

Siteman Cancer Center-South County

Saint Louis, Missouri, 63129

United States

Siteman Cancer Center at Christian Hospital

Saint Louis, Missouri, 63136

United States

Mercy Hospital Saint Louis

Saint Louis, Missouri, 63141

United States

Siteman Cancer Center at Saint Peters Hospital

Saint Peters, Missouri, 63376

United States

Mercy Hospital Springfield

Springfield, Missouri, 65804

United States

Nebraska Medicine-Bellevue

Bellevue, Nebraska, 68123

United States

Nebraska Medicine-Village Pointe

Omaha, Nebraska, 68118

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920

United States

Cooper Hospital University Medical Center

Camden, New Jersey, 08103

United States

Monmouth Medical Center Southern Campus

Lakewood, New Jersey, 08701

United States

Monmouth Medical Center

Long Branch, New Jersey, 07740

United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645

United States

Cooper CyberKnife Center

Mount Laurel, New Jersey, 08054

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

United States

Rutgers New Jersey Medical School

Newark, New Jersey, 07101

United States

Community Medical Center

Toms River, New Jersey, 08755

United States

Lovelace Medical Center-Saint Joseph Square

Albuquerque, New Mexico, 87102

United States

Lovelace Radiation Oncology

Albuquerque, New Mexico, 87109

United States

Memorial Sloan Kettering Commack

Commack, New York, 11725

United States

Glens Falls Hospital

Glens Falls, New York, 12801

United States

Memorial Sloan Kettering Westchester

Harrison, New York, 10604

United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Stony Brook University Medical Center

Stony Brook, New York, 11794

United States

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553

United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203

United States

Atrium Health Pineville/LCI-Pineville

Charlotte, North Carolina, 28210

United States

Atrium Health University City/LCI-University

Charlotte, North Carolina, 28262

United States

Levine Cancer Institute-Ballantyne

Charlotte, North Carolina, 28277

United States

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, 28025

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

Levine Cancer Institute-Gaston

Gastonia, North Carolina, 28054

United States

Atrium Health Union/LCI-Union

Monroe, North Carolina, 28112

United States

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501

United States

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122

United States

UH Seidman Cancer Center at UH Avon Health Center

Avon, Ohio, 44011

United States

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, 44122

United States

Dayton Physicians LLC-Miami Valley South

Centerville, Ohio, 45459

United States

Miami Valley Hospital South

Centerville, Ohio, 45459

United States

Case Western Reserve University

Cleveland, Ohio, 44106

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

Miami Valley Hospital

Dayton, Ohio, 45409

United States

Premier Blood and Cancer Center

Dayton, Ohio, 45409

United States

Dayton Physician LLC - Englewood

Dayton, Ohio, 45415

United States

Miami Valley Hospital North

Dayton, Ohio, 45415

United States

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066

United States

Dayton Physicians LLC-Atrium

Franklin, Ohio, 45005

United States

Miami Valley Cancer Care and Infusion

Greenville, Ohio, 45331

United States

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, 44060

United States

University Hospitals Parma Medical Center

Parma, Ohio, 44129

United States

University Hospitals Portage Medical Center

Ravenna, Ohio, 44266

United States

Upper Valley Medical Center

Troy, Ohio, 45373

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Oklahoma Cancer Specialists and Research Institute-Tulsa

Tulsa, Oklahoma, 74146

United States

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103

United States

UPMC-Heritage Valley Health System Beaver

Beaver, Pennsylvania, 15009

United States

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017

United States

Carlisle Regional Cancer Center

Carlisle, Pennsylvania, 17015

United States

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505

United States

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, 15601

United States

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, 17109

United States

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, 17050

United States

UPMC Hillman Cancer Center - New Castle

New Castle, Pennsylvania, 16105

United States

UPMC-Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213

United States

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, 15215

United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232

United States

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, 15232

United States

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, 15237

United States

UPMC-Saint Clair Hospital Cancer Center

Pittsburgh, Pennsylvania, 15243

United States

Reading Hospital

West Reading, Pennsylvania, 19611

United States

Divine Providence Hospital

Williamsport, Pennsylvania, 17754

United States

UPMC Memorial

York, Pennsylvania, 17408

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104

United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

United States

Parkland Memorial Hospital

Dallas, Texas, 75235

United States

UT Southwestern Simmons Cancer Center - RedBird

Dallas, Texas, 75237

United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390

United States

UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas, 76104

United States

UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, 75080

United States

Central Vermont Medical Center/National Life Cancer Treatment

Berlin, Vermont, 05602

United States

University of Vermont Medical Center

Burlington, Vermont, 05401

United States

University of Vermont and State Agricultural College

Burlington, Vermont, 05405

United States

Bon Secours Saint Francis Medical Center

Midlothian, Virginia, 23114

United States

Bon Secours Cancer Institute at Reynolds Crossing

Richmond, Virginia, 23230

United States

Virginia Mason Medical Center

Seattle, Washington, 98101

United States

West Virginia University Charleston Division

Charleston, West Virginia, 25304

United States

Edwards Comprehensive Cancer Center

Huntington, West Virginia, 25701

United States

Langlade Hospital and Cancer Center

Antigo, Wisconsin, 54409

United States

Duluth Clinic Ashland

Ashland, Wisconsin, 54806

United States

Northwest Wisconsin Cancer Center

Ashland, Wisconsin, 54806

United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701

United States

Essentia Health-Hayward Clinic

Hayward, Wisconsin, 54843

United States

Marshfield Medical Center - Ladysmith

Ladysmith, Wisconsin, 54848

United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, 53718

United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

United States

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548

United States

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, 53149

United States

Marshfield Medical Center - Neillsville

Neillsville, Wisconsin, 54456

United States

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, 54017

United States

Drexel Town Square Health Center

Oak Creek, Wisconsin, 53154

United States

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066

United States

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, 54501

United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868

United States

Essentia Health-Spooner Clinic

Spooner, Wisconsin, 54801

United States

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, 54481

United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482

United States

Essentia Health Saint Mary's Hospital - Superior

Superior, Wisconsin, 54880

United States

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188

United States

Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401

United States

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, 53095

United States

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476

United States

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, 54494

United States

Marshfield Clinic - Wisconsin Rapids Center

Wisconsin Rapids, Wisconsin, 54494

United States

Collaborators and Investigators

Sponsor: NRG Oncology

William A Hall, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-01

Study Completion Date2028-06-15

Study Record Updates

Study Start Date2023-02-01

Study Completion Date2028-06-15

Terms related to this study

Additional Relevant MeSH Terms

Metastatic Renal Cell Carcinoma
Stage III Renal Cell Cancer AJCC v8
Stage IV Renal Cell Cancer AJCC v8
Unresectable Renal Cell Carcinoma