Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy
Metastatic Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma, Stage II Renal Cell Cancer AJCC v7
About this trial
This is an interventional treatment trial for Metastatic Renal Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- ELIGIBILITY CRITERIA FOR RANDOMIZATION:
- Patients must have a renal mass consistent with a clinical stage >= T2Nx renal cell carcinoma (RCC) or TanyN+ RCC for which radical or partial nephrectomy is planned
Patients must have no clinical or radiological evidence of distant metastases (M0) unless the presumed M1 disease is planned to be resected/definitively treated (e.g., thermal ablation, stereotactic radiation) at the same time or up to 12 weeks after the date of the initial procedure such that the patient is considered "no evidence of disease" (M1 NED)
- Liver, bone, or brain metastases are not permitted
- No more than 3 metastases are permitted, and all must be able to be removed or definitively treated within 12 weeks of the primary tumor resection
If histological confirmation of RCC has not been done within 12 months prior to randomization, patient must be willing to undergo a core biopsy for this purpose if randomized to Arm A
NOTE: This histologic confirmation can be a (1) standard of care diagnostic biopsy or (2) a research biopsy or a planned metastasectomy. Tissue must be obtained with results available prior to the neoadjuvant dose
- Patients randomized to Arm A: core tumor biopsy must have demonstrated RCC of any histology, including sarcomatoid, unclassified, or "unknown histology" (if preoperative biopsy was uninformative) with exception below for non-diagnostic biopsies
- If the biopsy performed following randomization clearly demonstrates a benign condition, oncocytoma or a different type of cancer that is not RCC, the patient is not eligible and must come off study
- A non-diagnostic biopsy is considered a good faith effort and does not need to be repeated unless deemed clinically necessary by the treating investigator
Patient must not have any prior systemic or local anti-cancer therapy for the current RCC
- Patient must not have undergone a partial nephrectomy for the current RCC
- Patient must not have had a metastasectomy for the current RCC diagnosis unless performed to render patient NED (in addition to the planned nephrectomy) within 6 months prior to the current diagnosis
- Patient must not have received current or past antineoplastic systemic therapies for RCC: i.e., chemotherapy, hormonal therapy, immunotherapy, or standard or investigational agents for treatment of RCC
- Patient must not have received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Patient must be >= 18 years of age. Because no dosing or adverse event data are currently available on the use of nivolumab therapy in patients < 18 years of age, children are excluded from this study
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patient must not have a prior history of RCC that was treated with curative intent within the past 5 years
- Patients with a prior RCC that was treated > 5 years before, are eligible if the current tumor is consistent with a new primary in the opinion of the treating investigator
Patients with bilateral synchronous RCCs are eligible if they can be resected or definitively treated at the same time or within a 12 week window from time of initial nephrectomy (partial or radical) or procedure and maintain adequate residual renal function; the patient is not eligible if both kidneys are to be completely removed and subsequent hemodialysis will be required
Permitted forms of local therapy for second tumor:
- Partial or radical nephrectomy
- If kidney tumor is =< 3 cm: thermal ablation (e.g., radiofrequency ablation, cryoablation or stereotactic radiosurgery)
Patients cannot have concurrent malignancies, with the following exceptions:
- Adequately treated basal cell or squamous cell skin cancer
In situ cervical cancer
- A history of superficial Ta urothelial cancer is permitted (as long as not currently undergoing treatment) whereas T1 or greater disease is excluded if < 3 years from diagnosis; concurrent persistent disease is not permitted
- Adequately treated stage I or II cancer from which the patient is currently in complete remission
- Any other cancer and stage from which the patient has been disease-free for at least 3 years prior to the time of randomization and as long as they are not receiving any current treatment (e.g. adjuvant or maintenance systemic or local therapy)
- Concurrent low risk prostate cancer on active surveillance
- Patient must not have active known or suspected autoimmune disease. The following autoimmune disorders are permitted: patients with vitiligo, type I diabetes mellitus, controlled/stable hypo or hyperthyroidism due to autoimmune or non-autoimmune conditions (hormone replacement is allowed), psoriasis not requiring systemic treatment, or other conditions not expected to recur
Patient must not have any ongoing condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications with the exceptions outlined below; patient must not have received any treatment with other immunosuppressive agents within 14 days prior to the first dose of study drug with the following exceptions:
- Topical, ocular, intra-articular, intranasal, inhaled steroids and adrenal replacement steroid doses > 10 mg daily prednisone or the equivalent are permitted in the absence of active autoimmune disease
- A brief (less than 3 weeks) course of corticosteroids (any amount) for prophylaxis (for example: contrast dye allergy) or for treatment of non-autoimmune conditions (for example: nausea, delayed-type hypersensitivity reaction caused by a contact allergen) is permitted
- Patient must not have uncontrolled adrenal insufficiency
Patient must not have known evidence of chronic active liver disease or evidence of acute or chronic hepatitis B Virus (HBV) or hepatitis C (HCV); HBV and HCV testing must be completed within 8 weeks prior to randomization
- NOTE: If the patient has been treated and cured, and the HCV ribonucleic acid (RNA) is undetectable, the patient is eligible for this study
- Patient must not have any serious intercurrent illness, including ongoing or active infection requiring parenteral antibiotics
- Patient must not have known evidence of human immunodeficiency virus (HIV) infection, since the effects of nivolumab on anti-retroviral therapy have not been studied; HIV testing is only required if past or current history is suspected
- Patient must not have any known medical condition (e.g. a condition associated with uncontrolled diarrhea such as ulcerative colitis or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or interfere with the interpretation of safety results
- Patient must not have had any major surgery within 28 days prior to randomization
- Patient must not be currently enrolled in other clinical trials testing a therapeutic intervention
- Patient must not have any history of severe hypersensitivity to a monoclonal antibody
- Patient must have the ability to understand and the willingness to sign a written informed consent document
- Patients must not be pregnant or breast-feeding, as the effects of nivolumab on the developing human fetus or in the nursing infant are unknown; all patients of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy; a patient of childbearing potential is defined as any woman, 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 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, as described in the informed consent form (ICF), or by abstaining from sexual intercourse for the duration of their participation in the study; patients of childbearing potential must use adequate methods to avoid pregnancy for 5 months after the last dose of nivolumab
- White blood cells >= 2000/uL (within 8 weeks prior to randomization)
- Absolute neutrophil count (ANC) >= 1,500/mm^3 (within 8 weeks prior to randomization)
- Platelet count >= 100,000/mm^3 (within 8 weeks prior to randomization)
- Hemoglobin >= 9.0 g/dL (within 8 weeks prior to randomization)
- Serum creatinine =< 1.5 x upper limit of normal (ULN) or calculated creatinine clearance (CrCl) >= 40mL/min (within 8 weeks prior to randomization)
- Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 x ULN) (within 8 weeks prior to randomization)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN (within 8 weeks prior to randomization)
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Veterans Administration Medical Center - Birmingham
- Banner MD Anderson Cancer Center
- Cancer Center at Saint Joseph's
- Banner University Medical Center - Tucson
- University of Arizona Cancer Center-North Campus
- Kaiser Permanente-Anaheim
- Sutter Auburn Faith Hospital
- AIS Cancer Center at San Joaquin Community Hospital
- Kaiser Permanente-Baldwin Park
- Kaiser Permanente-Bellflower
- Alta Bates Summit Medical Center-Herrick Campus
- Mills-Peninsula Medical Center
- Community Cancer Institute
- City of Hope Comprehensive Cancer Center
- Kaiser Permanente-Fontana
- Kaiser Permanente - Harbor City
- Kaiser Permanente-Irvine
- UC San Diego Moores Cancer Center
- Kaiser Permanente Los Angeles Medical Center
- USC / Norris Comprehensive Cancer Center
- Kaiser Permanente West Los Angeles
- Cedars Sinai Medical Center
- UCLA / Jonsson Comprehensive Cancer Center
- Fremont - Rideout Cancer Center
- Palo Alto Medical Foundation-Camino Division
- USC Norris Oncology/Hematology-Newport Beach
- Kaiser Permanente-Oakland
- Kaiser Permanente-Ontario
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Palo Alto Medical Foundation Health Care
- Stanford Cancer Institute Palo Alto
- VA Palo Alto Health Care System
- Kaiser Permanente - Panorama City
- Eisenhower Medical Center
- Kaiser Permanente-Riverside
- Kaiser Permanente-Roseville
- Sutter Roseville Medical Center
- Kaiser Permanente Downtown Commons
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- Kaiser Permanente - Sacramento
- Kaiser Permanente-San Diego Zion
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Pacific Central Coast Health Center-San Luis Obispo
- Kaiser Permanente-San Marcos
- Kaiser Permanente Medical Center - Santa Clara
- Palo Alto Medical Foundation-Santa Cruz
- Kaiser Permanente-South San Francisco
- Palo Alto Medical Foundation-Sunnyvale
- Gene Upshaw Memorial Tahoe Forest Cancer Center
- Kaiser Permanente-Vallejo
- Sutter Solano Medical Center/Cancer Center
- Kaiser Permanente-Walnut Creek
- Presbyterian Intercommunity Hospital
- Kaiser Permanente-Woodland Hills
- UCHealth University of Colorado Hospital
- UCHealth Memorial Hospital Central
- Memorial Hospital North
- Poudre Valley Hospital
- Cancer Care and Hematology-Fort Collins
- UCHealth Greeley Hospital
- Medical Center of the Rockies
- Hartford Hospital
- Midstate Medical Center
- The Hospital of Central Connecticut
- Yale University
- Eastern Connecticut Hematology and Oncology Associates
- MedStar Washington Hospital Center
- Sibley Memorial Hospital
- George Washington University Medical Center
- UM Sylvester Comprehensive Cancer Center at Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
- Holy Cross Hospital
- University of Florida Health Science Center - Gainesville
- Baptist MD Anderson Cancer Center
- Lakeland Regional Health Hollis Cancer Center
- The Watson Clinic
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Miami Cancer Institute
- UM Sylvester Comprehensive Cancer Center at Kendall
- UM Sylvester Comprehensive Cancer Center at Plantation
- Emory University Hospital/Winship Cancer Institute
- Atlanta VA Medical Center
- 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
- Queen's Cancer Center - Kuakini
- Saint Luke's Cancer Institute - Boise
- Kootenai Health - Coeur d'Alene
- Saint Luke's Cancer Institute - Fruitland
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Kootenai Clinic Cancer Services - Post Falls
- Kootenai Cancer Clinic
- Saint Luke's Cancer Institute - Twin Falls
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Illinois CancerCare-Carthage
- Northwestern University
- Rush University Medical Center
- University of Illinois
- University of Chicago Comprehensive Cancer Center
- Carle at The Riverfront
- Cancer Care Specialists of Illinois - Decatur
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Elmhurst Memorial Hospital
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Northwestern Medicine Cancer Center Delnor
- Edward Hines Jr VA Hospital
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Loyola University Medical Center
- Edward Hospital/Cancer Center
- Cancer Care Center of O'Fallon
- Illinois CancerCare-Ottawa Clinic
- Illinois CancerCare-Pekin
- Illinois CancerCare-Peoria
- Illinois CancerCare-Peru
- Edward Hospital/Cancer Center?Plainfield
- Illinois CancerCare-Princeton
- Southern Illinois University School of Medicine
- Springfield Clinic
- Carle Cancer Center
- The Carle Foundation Hospital
- Northwestern Medicine Cancer Center Warrenville
- Parkview Regional Medical Center
- Indiana University/Melvin and Bren Simon Cancer Center
- Sidney and Lois Eskenazi Hospital
- Franciscan Health Indianapolis
- Woodland Cancer Care Center
- Franciscan Health Mooresville
- Reid Health
- Memorial Hospital of South Bend
- Mary Greeley Medical Center
- McFarland Clinic - Ames
- McFarland Clinic - Boone
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- McFarland Clinic - Trinity Cancer Center
- McFarland Clinic - Jefferson
- McFarland Clinic - Marshalltown
- Mercy Medical Center-West Lakes
- HaysMed University of Kansas Health System
- University of Kansas Cancer Center
- Lawrence Memorial Hospital
- Olathe Health Cancer Center
- University of Kansas Cancer Center-Overland Park
- Ascension Via Christi - Pittsburg
- Salina Regional Health Center
- Cotton O'Neil Cancer Center / Stormont Vail Health
- University of Kansas Health System Saint Francis Campus
- University of Kansas Hospital-Westwood Cancer Center
- University of Kentucky/Markey Cancer Center
- LSU Health Baton Rouge-North Clinic
- Louisiana Hematology Oncology Associates LLC
- Mary Bird Perkins Cancer Center
- Our Lady of the Lake Physicians Group - Medical Oncology
- Northshore Oncology Associates-Covington
- Oncology Center of The South Incorporated
- East Jefferson General Hospital
- LSU Healthcare Network / Metairie Multi-Specialty Clinic
- Louisiana State University Health Science Center
- Tulane University Health Sciences Center
- University Medical Center New Orleans
- Ochsner Medical Center Jefferson
- LSU Health Sciences Center at Shreveport
- Harold Alfond Center for Cancer Care
- Eastern Maine Medical Center
- Waldo County General Hospital
- MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
- Lafayette Family Cancer Center-EMMC
- Penobscot Bay Medical Center
- MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
- Maine Medical Partners - South Portland
- Greater Baltimore Medical Center
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Beverly Hospital
- Massachusetts General Hospital Cancer Center
- Brigham and Women's Hospital
- Boston Medical Center
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
- Lahey Hospital and Medical Center
- Simonds-Sinon Regional Cancer Center
- Winchester Hospital
- UMass Memorial Medical Center - University Campus
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Saint Joseph Mercy Brighton
- Saint Joseph Mercy Canton
- Saint Joseph Mercy Chelsea
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Weisberg Cancer Treatment Center
- Spectrum Health at Butterworth Campus
- Sparrow Hospital
- Ascension Providence Hospitals - Novi
- William Beaumont Hospital-Royal Oak
- Ascension Providence Hospitals - Southfield
- William Beaumont Hospital - Troy
- Abbott-Northwestern Hospital
- Minneapolis VA Medical Center
- Mayo Clinic in Rochester
- Coborn Cancer Center at Saint Cloud Hospital
- Gulfport Memorial Hospital
- University of Mississippi Medical Center
- Saint Francis Medical Center
- Saint Luke's Hospital
- MU Health - University Hospital/Ellis Fischel Cancer Center
- Siteman Cancer Center at West County Hospital
- Truman Medical Centers
- University of Kansas Cancer Center - North
- University of Kansas Cancer Center - Lee's Summit
- Washington University School of Medicine
- Missouri Baptist Medical Center
- Mercy Hospital Saint Louis
- Siteman Cancer Center at Saint Peters Hospital
- Bozeman Deaconess Hospital
- Benefis Healthcare- Sletten Cancer Institute
- CHI Health Saint Francis
- Nebraska Methodist Hospital
- OptumCare Cancer Care at Seven Hills
- OptumCare Cancer Care at Charleston
- Comprehensive Cancer Centers of Nevada - Town Center
- OptumCare Cancer Care at Fort Apache
- Comprehensive Cancer Centers of Nevada - Central Valley
- University Cancer Center
- Renown Regional Medical Center
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- Englewood Hospital and Medical Center
- Hackensack University Medical Center
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
- Rutgers Cancer Institute of New Jersey
- Robert Wood Johnson University Hospital Somerset
- Albany Medical Center
- Montefiore Medical Center-Einstein Campus
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center - Moses Campus
- James J Peters VA Medical Center
- Glens Falls Hospital
- Northwell Health/Center for Advanced Medicine
- Long Island Jewish Medical Center
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- NYP/Weill Cornell Medical Center
- University of Rochester
- State University of New York Upstate Medical University
- Dickstein Cancer Treatment Center
- Rex Hematology Oncology Associates-Cary
- UNC Lineberger Comprehensive Cancer Center
- Southeastern Medical Oncology Center-Clinton
- Duke University Medical Center
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Onslow Memorial Hospital
- Southeastern Medical Oncology Center-Jacksonville
- Vidant Oncology-Kenansville
- Vidant Oncology-Kinston
- Rex Hematology Oncology Associates-Blue Ridge
- UNC Rex Healthcare
- UNC Rex Cancer Center of Wakefield
- Vidant Oncology-Richlands
- Novant Health Forsyth Medical Center
- Wake Forest University Health Sciences
- Sanford Bismarck Medical Center
- Sanford Broadway Medical Center
- Sanford Roger Maris Cancer Center
- Summa Health System - Akron Campus
- UHHS-Chagrin Highlands Medical Center
- Dayton Physicians LLC-Miami Valley South
- University of Cincinnati Cancer Center-UC Medical Center
- Good Samaritan Hospital - Cincinnati
- Bethesda North Hospital
- Case Western Reserve University
- MetroHealth Medical Center
- Dayton Physicians LLC-Atrium
- Kettering Medical Center
- UH Seidman Cancer Center at Southwest General Hospital
- Toledo Clinic Cancer Centers-Toledo
- University of Cincinnati Cancer Center-West Chester
- UH Seidman Cancer Center at Saint John Medical Center
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma City
- Providence Cancer Institute Clackamas Clinic
- Rogue Valley Medical Center
- Providence Newberg Medical Center
- Providence Willamette Falls Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Kaiser Permanente Northwest
- Oregon Health and Science University
- Lehigh Valley Hospital-Cedar Crest
- Lehigh Valley Hospital - Muhlenberg
- Geisinger Medical Center
- Penn State Milton S Hershey Medical Center
- University of Pennsylvania/Abramson Cancer Center
- Fox Chase Cancer Center
- Temple University Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- Reading Hospital
- UPMC Susquehanna
- Rhode Island Hospital
- Miriam Hospital
- Prisma Health Cancer Institute - Spartanburg
- Ralph H Johnson VA Medical Center
- Medical University of South Carolina
- Prisma Health Cancer Institute - Laurens
- Prisma Health Cancer Institute - Easley
- Gibbs Cancer Center-Gaffney
- Saint Francis Hospital
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Saint Francis Cancer Center
- Prisma Health Cancer Institute - Eastside
- Prisma Health Cancer Institute - Greer
- Gibbs Cancer Center-Pelham
- Prisma Health Cancer Institute - Seneca
- Spartanburg Medical Center
- Lexington Medical Center
- Meharry Medical College
- Vanderbilt University/Ingram Cancer Center
- UT Southwestern/Simmons Cancer Center-Dallas
- UT Southwestern/Simmons Cancer Center-Fort Worth
- University of Texas Medical Branch
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- Ben Taub General Hospital
- UTMB Cancer Center at Victory Lakes
- UT Southwestern Clinical Center at Richardson/Plano
- Audie L Murphy VA Hospital
- University of Texas Health Science Center at San Antonio
- Farmington Health Center
- Huntsman Cancer Institute/University of Utah
- South Jordan Health Center
- Central Vermont Medical Center/National Life Cancer Treatment
- University of Vermont Medical Center
- University of Vermont and State Agricultural College
- University of Virginia Cancer Center
- Sovah Health Martinsville
- Bon Secours Memorial Regional Medical Center
- Bon Secours Saint Francis Medical Center
- Bon Secours Saint Mary's Hospital
- Virginia Commonwealth University/Massey Cancer Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Kadlec Clinic Hematology and Oncology
- FHCC South Lake Union
- Fred Hutchinson Cancer Research Center
- University of Washington Medical Center - Montlake
- Langlade Hospital and Cancer Center
- ThedaCare Regional Cancer Center
- Ascension Southeast Wisconsin Hospital - Elmbrook Campus
- Aurora Cancer Care-Southern Lakes VLCC
- Marshfield Medical Center-EC Cancer Center
- Aurora Health Center-Fond du Lac
- Ascension Saint Francis - Reiman Cancer Center
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Grafton
- Aurora BayCare Medical Center
- UW Cancer Center Johnson Creek
- Aurora Cancer Care-Kenosha South
- William S Middleton VA Medical Center
- University of Wisconsin Carbone Cancer Center
- Aurora Bay Area Medical Group-Marinette
- Marshfield Medical Center-Marshfield
- Aspirus Medford Hospital
- Aurora Cancer Care-Milwaukee
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Aurora Sinai Medical Center
- Marshfield Clinic-Minocqua Center
- ProHealth D N Greenwald Center
- ProHealth Oconomowoc Memorial Hospital
- Vince Lombardi Cancer Clinic - Oshkosh
- Aurora Cancer Care-Racine
- Marshfield Medical Center-Rice Lake
- Vince Lombardi Cancer Clinic-Sheboygan
- Marshfield Medical Center-River Region at Stevens Point
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- ProHealth Waukesha Memorial Hospital
- UW Cancer Center at ProHealth Care
- Aspirus Regional Cancer Center
- Marshfield Clinic-Wausau Center
- Ascension Medical Group Southeast Wisconsin - Mayfair Road
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Marshfield Medical Center - Weston
- Aspirus Cancer Care - Wisconsin Rapids
- Tom Baker Cancer Centre
- Cross Cancer Institute
- CancerCare Manitoba
- The Moncton Hospital
- QEII Health Sciences Centre/Nova Scotia Health Authority
- Saint Joseph's Healthcare Charlton Campus
- Juravinski Cancer Centre at Hamilton Health Sciences
- Kingston Health Sciences Centre
- London Regional Cancer Program
- Niagara Health System-Saint Catharines General
- Odette Cancer Centre- Sunnybrook Health Sciences Centre
- University Health Network-Princess Margaret Hospital
- Windsor Regional Cancer Centre
- CHUM - Centre Hospitalier de l'Universite de Montreal
- Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
- Rambam Medical Center
- Shaare Zedek Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I (nivolumab, nephrectomy)
Arm II (nephrectomy)
Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 2 cycles. Patients then undergo partial or radical nephrectomy 7-28 days later. Patients then receive nivolumab over 30 IV on day 1. Treatment repeats every 14 days for 6 cycles, and then every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients enrolled after Amendment 4 receive nivolumab IV over 30 minutes on day 1. Patients then undergo partial or radical nephrectomy 7-28 days later. Patient then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 9 cycles in the absence of disease progression or unacceptable toxicity.
Patients undergo partial or radical nephrectomy within 8 weeks after registration followed by observation.