Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial (PROBE)
Metastatic Clear Cell Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8
About this trial
This is an interventional treatment trial for Metastatic Clear Cell Renal Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- STEP 1 REGISTRATION: Participants must have a histologically proven diagnosis of clear cell or non-clear cell renal cell carcinoma. Participants with collecting duct carcinoma histology are not eligible. Participants with multifocal or bilateral tumors are eligible
- STEP 1 REGISTRATION: Participants must have primary tumor in place
STEP 1 REGISTRATION: Participants must have the following scans performed, showing clinical evidence of measurable or non-measurable metastatic disease:
- Computed tomography (CT) scan of the chest (can be performed without contrast if CT contrast cannot be given)
- CT of abdomen and pelvis with contrast OR magnetic resonance imaging (MRI) of the abdomen and pelvis with or without contrast
Scans must be performed within the following timeframes:
- Treatment naive participants must have scans documenting metastatic disease completed within 90 days prior to study registration
Previously treated participants must have scans documenting metastatic disease completed within 90 days prior to first dose of systemic treatment
- STEP 1 REGISTRATION: Participants with symptomatic metastases may have received palliative radiotherapy or receive palliative radiotherapy after registration
- STEP 1 REGISTRATION: Participants must have no clear contraindications to nephrectomy
- STEP 1 REGISTRATION: Participants must be offered the opportunity to participate in specimen bank. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
- STEP 1 REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
- STEP 1 REGISTRATION: As part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
- STEP 2 REGISTRATION: Participants must have at least one of the following scans performed 12 weeks (+/- 2 weeks) after starting pre-randomization treatment
- CT scan of the chest (can be performed without contrast if CT contrast cannot be given)
CT of abdomen and pelvis with contrast OR MRI of the abdomen and pelvis with or without contrast Scans must be performed within 28 days prior to randomization. Response should be assessed by comparing with a CT or MRI of the chest, abdomen and pelvis obtained prior to starting pre-randomization treatment. Participants with complete response in all metastatic sites are not eligible to randomize to Step 2
• STEP 2 REGISTRATION: Participants must have one of the following objective statuses after 12 weeks of pre-randomization treatment
- Stable disease
- Partial response
The treating investigator believes the patient is deriving clinical benefit from systemic therapy AND have Zubrod performance status 0-1
- STEP 2 REGISTRATION: Participants must plan to continue the immune-based therapy received during pre-randomization treatment
- STEP 2 REGISTRATION: Participants must be randomized on or between the 11th and 14th week of protocol-directed pre-randomization treatment therapy
- STEP 2 REGISTRATION: Participants must have received at least one of the minimum amounts of immunotherapy:
- 2 infusions of nivolumab + 1 infusion of ipilimumab
- 2 infusions of pembrolizumab
2 infusions of avelumab
- STEP 2 REGISTRATION: Participants must have a planned surgery date within 42 days of randomization
- STEP 2 REGISTRATION: Participants must be a surgical candidate as determined by study urologist. The urology consult should be done within 42 days prior to randomization
- STEP 2 REGISTRATION: Participants must have a complete physical examination and medical history within 28 days prior to randomization
- STEP 2 REGISTRATION: Participants must have a Zubrod performance status of 0-1 within 28 days prior to randomization
- STEP 2 REGISTRATION: Total bilirubin =< institutional upper limit of normal (ULN) (within 28 days prior to randomization)
- STEP 2 REGISTRATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional upper limit of normal (ULN) (within 28 days prior to randomization)
- STEP 2 REGISTRATION: Serum creatinine =< 1.5 x the institutional upper limit of normal (IULN) OR measured OR calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault Formula) (must have been drawn and processed within 28 days prior to randomization)
Exclusion Criteria:
- STEP 1 REGISTRATION: Participants must not have known active brain metastases. Participants with previously treated brain metastases are eligible if participant has no neurologic signs or symptoms suggestive of brain metastasis. Brain imaging studies are not required. If brain imaging studies are performed, they must be negative for disease
STEP 1 REGISTRATION: Participants must not have received the following prior treatment of metastatic renal cell carcinoma:
- Treatment naive participants must not have received any prior lines of systemic therapy for metastatic renal cell carcinoma beyond the line intended as part of protocol therapy
- Previously treated participants must not have received any systemic therapy for metastatic renal cell carcinoma beyond the one regimen received off protocol as specified in Step 1 pre-randomization treatment
STEP 1 REGISTRATION: Participants must not have received more than the following amounts protocol-directed pre-randomization treatment:
- Treatment naive participants must not have received any pre-randomization treatment.
Previously treated participants must not be planning to receive any additional treatment prior to Step 2 randomization, and must not have received more than the following amounts of pre-randomization treatment:
- 4 infusions of nivolumab
- 4 infusions of ipilimumab
- 4 infusions of pembrolizumab
- 7 infusions of avelumab
STEP 1 REGISTRATION: Participants must not have received immunotherapy for any cancer within the following timeframes:
- Treatment naive participants must not have received any immunotherapy within a year of registration
- Previously treated participants must not have received any other immunotherapy within a year of the start of off protocol specified pre-randomization treatment
- STEP 1 REGISTRATION: Participants must not have a solitary kidney and not have a transplanted kidney
- STEP 1 REGISTRATION: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, any in situ or T1 cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for at least two years
- STEP 1 REGISTRATION: Participants must not have been previously diagnosed with a medical condition that makes them ineligible for immune based combination therapy or nephrectomy
- STEP 2 REGISTRATION: Participants must not show progression in the primary tumor. Participants who are considered to have pseudo progression are allowed
- STEP 2 REGISTRATION: Participants must not have known active brain metastases. Participants with previously treated brain metastases are eligible if participant has no neurologic signs or symptoms suggestive of brain metastasis. Brain imaging studies are not required. If brain imaging studies are performed, they must be negative for disease
- STEP 2 REGISTRATION: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years
Sites / Locations
- University of Alabama at Birmingham Cancer CenterRecruiting
- Banner MD Anderson Cancer CenterRecruiting
- Kingman Regional Medical CenterRecruiting
- Banner University Medical Center - TucsonRecruiting
- University of Arizona Cancer Center-North CampusRecruiting
- Mercy Hospital Fort SmithRecruiting
- PCR OncologyRecruiting
- Sutter Auburn Faith HospitalRecruiting
- Sutter Cancer Centers Radiation Oncology Services-AuburnRecruiting
- Alta Bates Summit Medical Center-Herrick CampusRecruiting
- Keck Medicine of USC Buena ParkRecruiting
- Sutter Cancer Centers Radiation Oncology Services-Cameron ParkRecruiting
- Eden Hospital Medical CenterRecruiting
- Sutter Davis HospitalRecruiting
- City of Hope Comprehensive Cancer CenterRecruiting
- Palo Alto Medical Foundation-FremontRecruiting
- Keck Medicine of USC Huntington BeachRecruiting
- Keck Medicine of USC KoreatownRecruiting
- Los Angeles County-USC Medical CenterRecruiting
- USC / Norris Comprehensive Cancer CenterRecruiting
- Cedars Sinai Medical CenterRecruiting
- UCLA / Jonsson Comprehensive Cancer CenterRecruiting
- Memorial Medical CenterRecruiting
- Palo Alto Medical Foundation-Camino DivisionRecruiting
- Palo Alto Medical Foundation-Gynecologic OncologyRecruiting
- USC Norris Oncology/Hematology-Newport BeachRecruiting
- Sutter Cancer Research ConsortiumRecruiting
- Palo Alto Medical Foundation Health CareRecruiting
- Keck Medical Center of USC PasadenaRecruiting
- Sutter Cancer Centers Radiation Oncology Services-RosevilleRecruiting
- Sutter Roseville Medical CenterRecruiting
- Sutter Medical Center SacramentoRecruiting
- University of California Davis Comprehensive Cancer CenterRecruiting
- California Pacific Medical Center-Pacific CampusRecruiting
- Mills Health CenterRecruiting
- Palo Alto Medical Foundation-Santa CruzRecruiting
- Sutter Pacific Medical FoundationRecruiting
- City of Hope South PasadenaRecruiting
- Palo Alto Medical Foundation-SunnyvaleRecruiting
- Cedars-Sinai Cancer - TarzanaRecruiting
- City of Hope UplandRecruiting
- Sutter Cancer Centers Radiation Oncology Services-VacavilleRecruiting
- Sutter Solano Medical Center/Cancer CenterRecruiting
- MedStar Washington Hospital CenterRecruiting
- AdventHealth AltamonteRecruiting
- AdventHealth CelebrationRecruiting
- AdventHealth KissimmeeRecruiting
- AdventHealth Medical Group Urology at OrlandoRecruiting
- AdventHealth OrlandoRecruiting
- Orlando Health Cancer InstituteRecruiting
- AdventHealth East OrlandoRecruiting
- AdventHealth Winter ParkRecruiting
- Saint Anthony's HealthRecruiting
- Rush - Copley Medical CenterRecruiting
- Advocate Good Shepherd HospitalRecruiting
- Illinois CancerCare-BloomingtonRecruiting
- Loyola Center for Health at Burr RidgeRecruiting
- Illinois CancerCare-CantonRecruiting
- Memorial Hospital of CarbondaleRecruiting
- SIH Cancer InstituteRecruiting
- Illinois CancerCare-CarthageRecruiting
- Centralia Oncology ClinicRecruiting
- Saint Mary's HospitalRecruiting
- Northwestern UniversityRecruiting
- Rush University Medical CenterRecruiting
- University of IllinoisRecruiting
- University of Chicago Comprehensive Cancer Center
- Advocate Illinois Masonic Medical CenterRecruiting
- AMG Crystal Lake - OncologyRecruiting
- Carle at The RiverfrontRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Northwestern Medicine Cancer Center KishwaukeeRecruiting
- Illinois CancerCare-DixonRecruiting
- Advocate Good Samaritan HospitalRecruiting
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- Advocate Sherman HospitalRecruiting
- Elmhurst Memorial HospitalRecruiting
- Illinois CancerCare-EurekaRecruiting
- Illinois CancerCare-GalesburgRecruiting
- Western Illinois Cancer Treatment CenterRecruiting
- Northwestern Medicine Cancer Center DelnorRecruiting
- Advocate South Suburban HospitalRecruiting
- Loyola Medicine Homer GlenRecruiting
- Illinois CancerCare-Kewanee ClinicRecruiting
- Northwestern Medicine Lake Forest HospitalRecruiting
- AMG Libertyville - OncologyRecruiting
- Condell Memorial HospitalRecruiting
- Illinois CancerCare-MacombRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Loyola University Medical CenterRecruiting
- Marjorie Weinberg Cancer Center at Loyola-GottliebRecruiting
- Good Samaritan Regional Health CenterRecruiting
- Edward Hospital/Cancer CenterRecruiting
- UC Comprehensive Cancer Center at Silver Cross
- Cancer Care Center of O'FallonRecruiting
- Advocate Christ Medical CenterRecruiting
- University of Chicago Medicine-Orland Park
- Illinois CancerCare-Ottawa ClinicRecruiting
- Advocate Lutheran General HospitalRecruiting
- Illinois CancerCare-PekinRecruiting
- Illinois CancerCare-PeoriaRecruiting
- Methodist Medical Center of IllinoisRecruiting
- Illinois CancerCare-PeruRecruiting
- Valley Radiation OncologyRecruiting
- Edward Hospital/Cancer Center?PlainfieldRecruiting
- Illinois CancerCare-PrincetonRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Carle Cancer CenterRecruiting
- The Carle Foundation HospitalRecruiting
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- Illinois CancerCare - WashingtonRecruiting
- Rush-Copley Healthcare CenterRecruiting
- Reid HealthRecruiting
- Mary Greeley Medical CenterRecruiting
- McFarland Clinic - AmesRecruiting
- McFarland Clinic - BooneRecruiting
- Saint Anthony Regional Hospital
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Broadlawns Medical Center
- Iowa Lutheran Hospital
- McFarland Clinic - Trinity Cancer CenterRecruiting
- Trinity Regional Medical Center
- McFarland Clinic - JeffersonRecruiting
- McFarland Clinic - MarshalltownRecruiting
- Methodist West Hospital
- Central Care Cancer Center - Garden CityRecruiting
- Central Care Cancer Center - Great BendRecruiting
- University of Kentucky/Markey Cancer CenterRecruiting
- Hematology/Oncology Clinic PLLC
- East Jefferson General HospitalRecruiting
- LSU Healthcare Network / Metairie Multi-Specialty ClinicRecruiting
- Louisiana State University Health Science CenterRecruiting
- Tulane University Health Sciences CenterRecruiting
- University Medical Center New OrleansRecruiting
- University of Michigan Comprehensive Cancer CenterRecruiting
- Bronson Battle CreekRecruiting
- University of Michigan - Brighton Center for Specialty CareRecruiting
- Henry Ford Cancer Institute-Downriver
- Henry Ford Hematology Oncology - Hayes
- Henry Ford Macomb Hospital-Clinton Township
- Henry Ford Medical Center-Fairlane
- Henry Ford Hospital
- Helen DeVos Children's Hospital at Spectrum HealthRecruiting
- Spectrum Health at Butterworth CampusRecruiting
- Trinity Health Grand Rapids HospitalRecruiting
- Allegiance Health
- Bronson Methodist HospitalRecruiting
- West Michigan Cancer CenterRecruiting
- Ascension Borgess Cancer CenterRecruiting
- Borgess Medical CenterRecruiting
- Trinity Health Muskegon HospitalRecruiting
- Lakeland Hospital NilesRecruiting
- Cancer and Hematology Centers of Western Michigan - Norton ShoresRecruiting
- Henry Ford Medical Center-Columbus
- Spectrum Health Reed City HospitalRecruiting
- Lakeland Medical Center Saint JosephRecruiting
- Marie Yeager Cancer CenterRecruiting
- Henry Ford Macomb Health Center - Shelby Township
- Munson Medical CenterRecruiting
- Henry Ford West Bloomfield Hospital
- Henry Ford Wyandotte Hospital
- University of Michigan Health - WestRecruiting
- Fairview Ridges Hospital
- Minnesota Oncology - BurnsvilleRecruiting
- Cambridge Medical CenterRecruiting
- Mercy HospitalRecruiting
- Fairview Southdale HospitalRecruiting
- Unity HospitalRecruiting
- Fairview Clinics and Surgery Center Maple GroveRecruiting
- Minnesota Oncology Hematology PA-MaplewoodRecruiting
- Saint John's Hospital - HealtheastRecruiting
- Abbott-Northwestern HospitalRecruiting
- Hennepin County Medical CenterRecruiting
- Health Partners IncRecruiting
- Monticello Cancer CenterRecruiting
- New Ulm Medical CenterRecruiting
- Fairview Northland Medical CenterRecruiting
- North Memorial Medical Health CenterRecruiting
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- Regions HospitalRecruiting
- United HospitalRecruiting
- Saint Francis Regional Medical CenterRecruiting
- Lakeview HospitalRecruiting
- Ridgeview Medical CenterRecruiting
- Rice Memorial HospitalRecruiting
- Minnesota Oncology Hematology PA-WoodburyRecruiting
- Fairview Lakes Medical CenterRecruiting
- Gulfport Memorial HospitalRecruiting
- Saint Louis Cancer and Breast Institute-BallwinRecruiting
- Central Care Cancer Center - BolivarRecruiting
- Cox Cancer Center BransonRecruiting
- Saint Francis Medical CenterRecruiting
- Southeast Cancer CenterRecruiting
- Parkland Health Center - FarmingtonRecruiting
- Capital Region Southwest CampusRecruiting
- Freeman Health SystemRecruiting
- Mercy Hospital JoplinRecruiting
- Delbert Day Cancer Institute at PCRMCRecruiting
- Mercy Clinic-Rolla-Cancer and HematologyRecruiting
- Heartland Regional Medical CenterRecruiting
- Saint Louis Cancer and Breast Institute-South CityRecruiting
- Mercy Hospital SouthRecruiting
- Missouri Baptist Medical CenterRecruiting
- Mercy Hospital Saint LouisRecruiting
- Sainte Genevieve County Memorial HospitalRecruiting
- Mercy Hospital SpringfieldRecruiting
- CoxHealth South HospitalRecruiting
- Missouri Baptist Sullivan HospitalRecruiting
- Missouri Baptist Outpatient Center-Sunset HillsRecruiting
- Mercy Hospital WashingtonRecruiting
- Nebraska Cancer Specialists/Oncology Hematology West PC - MECCRecruiting
- Nebraska Methodist HospitalRecruiting
- Oncology Associates PCRecruiting
- Carson Tahoe Regional Medical CenterRecruiting
- Cancer and Blood Specialists-HendersonRecruiting
- Comprehensive Cancer Centers of Nevada - HendersonRecruiting
- Comprehensive Cancer Centers of Nevada-Horizon RidgeRecruiting
- Las Vegas Cancer Center-Henderson
- OptumCare Cancer Care at Seven HillsRecruiting
- Comprehensive Cancer Centers of Nevada-Southeast HendersonRecruiting
- GenesisCare USA - HendersonRecruiting
- Las Vegas Urology - Green ValleyRecruiting
- Las Vegas Urology - PebbleRecruiting
- Urology Specialists of Nevada - Green ValleyRecruiting
- Las Vegas Urology - PecosRecruiting
- Desert West Surgery
- OptumCare Cancer Care at CharlestonRecruiting
- University Medical Center of Southern NevadaRecruiting
- Hope Cancer Care of NevadaRecruiting
- Radiation Oncology Centers of Nevada CentralRecruiting
- Urology Specialists of Nevada - CentralRecruiting
- GenesisCare USA - Las VegasRecruiting
- Sunrise Hospital and Medical CenterRecruiting
- Las Vegas Prostate Cancer CenterRecruiting
- Las Vegas Urology - SunsetRecruiting
- Urology Specialists of Nevada - SouthwestRecruiting
- Radiation Oncology Centers of Nevada SoutheastRecruiting
- Ann M Wierman MD LTDRecruiting
- Comprehensive Cancer Centers of Nevada - NorthwestRecruiting
- GenesisCare USA - Vegas TenayaRecruiting
- Las Vegas Urology - Cathedral RockRecruiting
- Las Vegas Urology - Smoke RanchRecruiting
- OptumCare Cancer Care at MountainViewRecruiting
- Urology Specialists of Nevada - NorthwestRecruiting
- Alliance for Childhood Diseases/Cure 4 the Kids FoundationRecruiting
- Comprehensive Cancer Centers of Nevada - Town CenterRecruiting
- Comprehensive Cancer Centers of Nevada-SummerlinRecruiting
- Summerlin Hospital Medical CenterRecruiting
- Las Vegas Cancer Center-Medical Center
- Comprehensive Cancer Centers of NevadaRecruiting
- GenesisCare USA - Fort ApacheRecruiting
- OptumCare Cancer Care at Fort ApacheRecruiting
- Comprehensive Cancer Centers of Nevada - Central ValleyRecruiting
- University Cancer CenterRecruiting
- Hope Cancer Care of Nevada-PahrumpRecruiting
- Renown Regional Medical CenterRecruiting
- Saint Mary's Regional Medical CenterRecruiting
- Radiation Oncology AssociatesRecruiting
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
- Hackensack University Medical CenterRecruiting
- University of New Mexico Cancer CenterRecruiting
- Roswell Park Cancer InstituteRecruiting
- Northwell Health/Center for Advanced MedicineRecruiting
- University of RochesterRecruiting
- Phelps Memorial Hospital CenterRecruiting
- Southeastern Medical Oncology Center-Clinton
- Southeastern Medical Oncology Center-Goldsboro
- Southeastern Medical Oncology Center-Jacksonville
- UH Seidman Cancer Center at UH Avon Health CenterRecruiting
- UHHS-Chagrin Highlands Medical CenterRecruiting
- Indu and Raj Soin Medical CenterRecruiting
- Saint Elizabeth Boardman HospitalRecruiting
- Dayton Physicians LLC-Miami Valley SouthRecruiting
- Miami Valley Hospital South
- University of Cincinnati Cancer Center-UC Medical CenterRecruiting
- Oncology Hematology Care Inc-KenwoodRecruiting
- Case Western Reserve UniversityRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital NorthRecruiting
- Miami Valley Hospital North
- Armes Family Cancer CenterRecruiting
- Blanchard Valley HospitalRecruiting
- Orion Cancer CareRecruiting
- Atrium Medical Center-Middletown Regional Hospital
- Dayton Physicians LLC-AtriumRecruiting
- Dayton Physicians LLC-WayneRecruiting
- Wayne HospitalRecruiting
- Greater Dayton Cancer CenterRecruiting
- Kettering Medical CenterRecruiting
- UH Seidman Cancer Center at Lake Health Mentor CampusRecruiting
- Springfield Regional Cancer Center
- Springfield Regional Medical Center
- University of Toledo
- Dayton Physicians LLC - TroyRecruiting
- Upper Valley Medical Center
- Saint Joseph Warren HospitalRecruiting
- University of Cincinnati Cancer Center-West ChesterRecruiting
- Saint Elizabeth Youngstown HospitalRecruiting
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma CityRecruiting
- Kaiser Sunnyside Medical CenterRecruiting
- Rogue Valley Medical Center
- Kaiser Permanente NorthwestRecruiting
- Oregon Health and Science UniversityRecruiting
- UPMC AltoonaRecruiting
- UPMC-Heritage Valley Health System BeaverRecruiting
- UPMC Hillman Cancer Center at Butler Health SystemRecruiting
- UPMC Hillman Cancer Center ErieRecruiting
- UPMC Cancer Center at UPMC HorizonRecruiting
- UPMC Cancer Centers - Arnold Palmer PavilionRecruiting
- IRMC Cancer CenterRecruiting
- UPMC-Johnstown/John P. Murtha Regional Cancer CenterRecruiting
- UPMC Cancer Center at UPMC McKeesportRecruiting
- UPMC Hillman Cancer Center - MonroevilleRecruiting
- 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
- UPMC-Saint MargaretRecruiting
- University of Pittsburgh Cancer Institute (UPCI)Recruiting
- UPMC-Shadyside HospitalRecruiting
- 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
- Prisma Health Cancer Institute - Spartanburg
- Medical University of South CarolinaRecruiting
- Prisma Health Cancer Institute - Easley
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Greenville Memorial Hospital
- Prisma Health Cancer Institute - Eastside
- Prisma Health Cancer Institute - Greer
- Prisma Health Cancer Institute - Seneca
- UT Southwestern Simmons Cancer Center - RedBirdRecruiting
- UT Southwestern/Simmons Cancer Center-DallasRecruiting
- UT Southwestern/Simmons Cancer Center-Fort WorthRecruiting
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterRecruiting
- Ben Taub General HospitalRecruiting
- UT Southwestern Clinical Center at Richardson/PlanoRecruiting
- University of Texas Health Science Center at San AntonioRecruiting
- University of Utah Sugarhouse Health CenterRecruiting
- Huntsman Cancer Institute/University of UtahRecruiting
- George E Wahlen Department of Veterans Affairs Medical CenterRecruiting
- Norris Cotton Cancer Center-NorthRecruiting
- Overlake Medical Center
- Valley Medical CenterRecruiting
- North Star Lodge Cancer Center at Yakima Valley Memorial HospitalRecruiting
- Aurora Cancer Care-Southern Lakes VLCCRecruiting
- Marshfield Clinic-Chippewa CenterRecruiting
- Marshfield Medical Center-EC Cancer CenterRecruiting
- Aurora Health Care Germantown Health CenterRecruiting
- Aurora Cancer Care-GraftonRecruiting
- Aurora BayCare Medical CenterRecruiting
- Aurora Cancer Care-Kenosha SouthRecruiting
- Marshfield Clinic - Ladysmith CenterRecruiting
- Aurora Bay Area Medical Group-MarinetteRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Froedtert Menomonee Falls HospitalRecruiting
- Aurora Cancer Care-MilwaukeeRecruiting
- Aurora Saint Luke's Medical CenterRecruiting
- Medical College of WisconsinRecruiting
- Aurora Sinai Medical CenterRecruiting
- Marshfield Clinic-Minocqua CenterRecruiting
- Cancer Center of Western WisconsinRecruiting
- Drexel Town Square Health CenterRecruiting
- Vince Lombardi Cancer Clinic - OshkoshRecruiting
- Aurora Cancer Care-RacineRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- Vince Lombardi Cancer Clinic-SheboyganRecruiting
- Marshfield Medical Center-River Region at Stevens PointRecruiting
- Aurora Medical Center in SummitRecruiting
- Vince Lombardi Cancer Clinic-Two RiversRecruiting
- Marshfield Clinic-Wausau CenterRecruiting
- Aurora Cancer Care-Milwaukee WestRecruiting
- Aurora West Allis Medical CenterRecruiting
- Froedtert West Bend Hospital/Kraemer Cancer CenterRecruiting
- Marshfield Medical Center - WestonRecruiting
- Marshfield Clinic - Wisconsin Rapids CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm 1: Continued Systemic Therapy Only
Arm 2: Nephrectomy and Continued Systemic Therapy
Nivolumab 240 mg IV 1 q 2 weeks OR Nivolumab 480 mg IV 1 q 4 weeks OR Pembrolizumab 200 mg IV 1 q 3 weeks Axitinib 5 mg oral Daily BID OR Avelumab 10 mg/kg IV 1 q 2 weeks Axitinib 5 mg oral Daily BID
Continued systemic therapy as above, plus: Radical or partial nephrectomy may be performed using laparoscopic, open, or robotic approaches. Surgery should be performed within 8 weeks of randomization.