A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients With Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

Who is this study for? Patients with localized kidney cancer undergoing nephrectomy
Status: Active, not recruiting
Location: See all (415) locations...
Intervention Type: Other, Biological, Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney) with nivolumab to the usual approach of nephrectomy followed by standard post-operative follow-up and monitoring, in treating patients with kidney cancer that is limited to a certain part of the body (localized). Nivolumab is a drug that may help stimulate the immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab to the usual surgery could prevent the cancer from returning. It is not yet known whether nivolumab and nephrectomy is more effective than nephrectomy alone in treating patients with kidney cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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)

Locations
United States
Alabama
University of Alabama at Birmingham Cancer Center
Birmingham
Veterans Administration Medical Center - Birmingham
Birmingham
Arizona
Banner MD Anderson Cancer Center
Gilbert
Cancer Center at Saint Joseph's
Phoenix
Banner University Medical Center - Tucson
Tucson
University of Arizona Cancer Center-North Campus
Tucson
California
Kaiser Permanente-Anaheim
Anaheim
Sutter Auburn Faith Hospital
Auburn
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield
Kaiser Permanente-Baldwin Park
Baldwin Park
Kaiser Permanente-Bellflower
Bellflower
Alta Bates Summit Medical Center-Herrick Campus
Berkeley
Mills-Peninsula Medical Center
Burlingame
Community Cancer Institute
Clovis
City of Hope Comprehensive Cancer Center
Duarte
Kaiser Permanente-Fontana
Fontana
Kaiser Permanente - Harbor City
Harbor City
Kaiser Permanente-Irvine
Irvine
UC San Diego Moores Cancer Center
La Jolla
Cedars Sinai Medical Center
Los Angeles
Kaiser Permanente Los Angeles Medical Center
Los Angeles
Kaiser Permanente West Los Angeles
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
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USC / Norris Comprehensive Cancer Center
Los Angeles
Fremont - Rideout Cancer Center
Marysville
Palo Alto Medical Foundation-Camino Division
Mountain View
USC Norris Oncology/Hematology-Newport Beach
Newport Beach
Kaiser Permanente-Oakland
Oakland
Kaiser Permanente-Ontario
Ontario
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange
Palo Alto Medical Foundation Health Care
Palo Alto
Stanford Cancer Institute Palo Alto
Palo Alto
VA Palo Alto Health Care System
Palo Alto
Kaiser Permanente - Panorama City
Panorama City
Eisenhower Medical Center
Rancho Mirage
Kaiser Permanente-Riverside
Riverside
Kaiser Permanente-Roseville
Roseville
Sutter Roseville Medical Center
Roseville
Kaiser Permanente - Sacramento
Sacramento
Kaiser Permanente Downtown Commons
Sacramento
Sutter Medical Center Sacramento
Sacramento
University of California Davis Comprehensive Cancer Center
Sacramento
Kaiser Permanente-San Diego Zion
San Diego
California Pacific Medical Center-Pacific Campus
San Francisco
Kaiser Permanente-San Francisco
San Francisco
Kaiser Permanente-Santa Teresa-San Jose
San Jose
Kaiser Permanente San Leandro
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Pacific Central Coast Health Center-San Luis Obispo
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San Marcos
Kaiser Permanente Medical Center - Santa Clara
Santa Clara
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz
Kaiser Permanente-South San Francisco
South San Francisco
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee
Kaiser Permanente-Vallejo
Vallejo
Sutter Solano Medical Center/Cancer Center
Vallejo
Kaiser Permanente-Walnut Creek
Walnut Creek
Presbyterian Intercommunity Hospital
Whittier
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Colorado
University of Colorado Hospital
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Memorial Hospital North
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Colorado Springs
Cancer Care and Hematology-Fort Collins
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Poudre Valley Hospital
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UCHealth Greeley Hospital
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Medical Center of the Rockies
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Connecticut
Hartford Hospital
Hartford
Midstate Medical Center
Meriden
The Hospital of Central Connecticut
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Yale University
New Haven
Eastern Connecticut Hematology and Oncology Associates
Norwich
Washington, D.c.
George Washington University Medical Center
Washington
MedStar Washington Hospital Center
Washington
Sibley Memorial Hospital
Washington
Florida
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach
Holy Cross Hospital
Fort Lauderdale
University of Florida Health Science Center - Gainesville
Gainesville
Baptist MD Anderson Cancer Center
Jacksonville
Lakeland Regional Health Hollis Cancer Center
Lakeland
The Watson Clinic
Lakeland
Miami Cancer Institute
Miami
UM Sylvester Comprehensive Cancer Center at Kendall
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation
Georgia
Emory University Hospital/Winship Cancer Institute
Atlanta
Atlanta VA Medical Center
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Hawaii
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'aiea
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'aiea
Hawaii Cancer Care Inc - Waterfront Plaza
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Queen's Cancer Cenrer - POB I
Honolulu
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Honolulu
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Honolulu
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Honolulu
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Ames
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Clive
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Chicago
Carle on Vermilion
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Effingham
Elmhurst Memorial Hospital
Elmhurst
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Eureka
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Galesburg
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Kewanee
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Carle Physician Group-Mattoon/Charleston
Mattoon
Loyola University Medical Center
Maywood
Edward Hospital/Cancer Center
Naperville
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O'fallon
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Ottawa
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Peru
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Plainfield
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Fort Wayne
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Michigan City
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Richmond
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Lawrence
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Olathe
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Ascension Via Christi - Pittsburg
Pittsburg
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Salina
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Topeka
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Westwood
Kentucky
University of Kentucky/Markey Cancer Center
Lexington
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Louisiana Hematology Oncology Associates LLC
Baton Rouge
LSU Health Baton Rouge-North Clinic
Baton Rouge
Mary Bird Perkins Cancer Center
Baton Rouge
Our Lady of the Lake Physicians Group - Medical Oncology
Baton Rouge
Northshore Oncology Associates-Covington
Covington
Oncology Center of The South Incorporated
Houma
East Jefferson General Hospital
Metairie
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie
Louisiana State University Health Science Center
New Orleans
Ochsner Medical Center Jefferson
New Orleans
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New Orleans
University Medical Center New Orleans
New Orleans
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Shreveport
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Beverly
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Boston
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Boston
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Boston
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Boston
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Boston
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Burlington
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Fitchburg
Winchester Hospital
Winchester
UMass Memorial Medical Center - University Campus
Worcester
Maryland
Greater Baltimore Medical Center
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore
Maine
Harold Alfond Center for Cancer Care
Augusta
Eastern Maine Medical Center
Bangor
Waldo County General Hospital
Belfast
MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
Biddeford
Lafayette Family Cancer Center-EMMC
Brewer
Penobscot Bay Medical Center
Rockport
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Sanford
Maine Medical Partners - South Portland
South Portland
Michigan
Saint Joseph Mercy Hospital
Ann Arbor
University of Michigan Comprehensive Cancer Center
Ann Arbor
Saint Joseph Mercy Brighton
Brighton
Saint Joseph Mercy Canton
Canton
Saint Joseph Mercy Chelsea
Chelsea
Henry Ford Hospital
Detroit
Wayne State University/Karmanos Cancer Institute
Detroit
Weisberg Cancer Treatment Center
Farmington Hills
Spectrum Health at Butterworth Campus
Grand Rapids
Sparrow Hospital
Lansing
Ascension Providence Hospitals - Novi
Novi
William Beaumont Hospital-Royal Oak
Royal Oak
Ascension Providence Hospitals - Southfield
Southfield
William Beaumont Hospital - Troy
Troy
Minnesota
Abbott-Northwestern Hospital
Minneapolis
Minneapolis VA Medical Center
Minneapolis
Mayo Clinic in Rochester
Rochester
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud
Missouri
Saint Francis Medical Center
Cape Girardeau
Saint Luke's Hospital
Chesterfield
University of Missouri - Ellis Fischel
Columbia
Siteman Cancer Center at West County Hospital
Creve Coeur
Truman Medical Centers
Kansas City
University of Kansas Cancer Center - North
Kansas City
University of Kansas Cancer Center - Lee's Summit
Lee's Summit
Mercy Hospital Saint Louis
Saint Louis
Missouri Baptist Medical Center
Saint Louis
Washington University School of Medicine
Saint Louis
Siteman Cancer Center at Saint Peters Hospital
Saint Peters
Mississippi
Gulfport Memorial Hospital
Gulfport
University of Mississippi Medical Center
Jackson
Montana
Bozeman Deaconess Hospital
Bozeman
Benefis Healthcare- Sletten Cancer Institute
Great Falls
North Carolina
Rex Hematology Oncology Associates-Cary
Cary
UNC Lineberger Comprehensive Cancer Center
Chapel Hill
Southeastern Medical Oncology Center-Clinton
Clinton
Duke University Medical Center
Durham
Southeastern Medical Oncology Center-Goldsboro
Goldsboro
Wayne Memorial Hospital
Goldsboro
Onslow Memorial Hospital
Jacksonville
Southeastern Medical Oncology Center-Jacksonville
Jacksonville
Vidant Oncology-Kenansville
Kenansville
Vidant Oncology-Kinston
Kinston
Rex Hematology Oncology Associates-Blue Ridge
Raleigh
UNC Rex Cancer Center of Wakefield
Raleigh
UNC Rex Healthcare
Raleigh
Vidant Oncology-Richlands
Richlands
Novant Health Forsyth Medical Center
Winston-salem
Wake Forest University Health Sciences
Winston-salem
North Dakota
Sanford Bismarck Medical Center
Bismarck
Sanford Broadway Medical Center
Fargo
Sanford Roger Maris Cancer Center
Fargo
Nebraska
CHI Health Saint Francis
Grand Island
Nebraska Methodist Hospital
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon
New Jersey
Englewood Hospital and Medical Center
Englewood
Hackensack University Medical Center
Hackensack
Rutgers Cancer Institute of New Jersey
New Brunswick
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick
Robert Wood Johnson University Hospital Somerset
Somerville
Nevada
OptumCare Cancer Care at Seven Hills
Henderson
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas
OptumCare Cancer Care at Charleston
Las Vegas
OptumCare Cancer Care at Fort Apache
Las Vegas
University Cancer Center
Las Vegas
Renown Regional Medical Center
Reno
New York
Albany Medical Center
Albany
James J Peters VA Medical Center
Bronx
Montefiore Medical Center - Moses Campus
Bronx
Montefiore Medical Center-Einstein Campus
Bronx
Montefiore Medical Center-Weiler Hospital
Bronx
Glens Falls Hospital
Glens Falls
Northwell Health/Center for Advanced Medicine
Lake Success
Long Island Jewish Medical Center
New Hyde Park
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York
NYP/Weill Cornell Medical Center
New York
University of Rochester
Rochester
State University of New York Upstate Medical University
Syracuse
Dickstein Cancer Treatment Center
White Plains
Ohio
Summa Health System - Akron Campus
Akron
UHHS-Chagrin Highlands Medical Center
Beachwood
Dayton Physicians LLC-Miami Valley South
Centerville
Bethesda North Hospital
Cincinnati
Good Samaritan Hospital - Cincinnati
Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati
Case Western Reserve University
Cleveland
MetroHealth Medical Center
Cleveland
Dayton Physicians LLC-Atrium
Franklin
Kettering Medical Center
Kettering
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights
Toledo Clinic Cancer Centers-Toledo
Toledo
University of Cincinnati Cancer Center-West Chester
West Chester
UH Seidman Cancer Center at Saint John Medical Center
Westlake
Oklahoma
Mercy Hospital Oklahoma City
Oklahoma City
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
Providence Cancer Institute Clackamas Clinic
Clackamas
Rogue Valley Medical Center
Medford
Providence Newberg Medical Center
Newberg
Providence Willamette Falls Medical Center
Oregon City
Kaiser Permanente Northwest
Portland
Oregon Health and Science University
Portland
Providence Portland Medical Center
Portland
Providence Saint Vincent Medical Center
Portland
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Allentown
Lehigh Valley Hospital - Muhlenberg
Bethlehem
Geisinger Medical Center
Danville
Penn State Milton S Hershey Medical Center
Hershey
Fox Chase Cancer Center
Philadelphia
Temple University Hospital
Philadelphia
University of Pennsylvania/Abramson Cancer Center
Philadelphia
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh
Reading Hospital
West Reading
UPMC Susquehanna
Williamsport
Rhode Island
Miriam Hospital
Providence
Rhode Island Hospital
Providence
South Carolina
Prisma Health Cancer Institute - Spartanburg
Boiling Springs
Medical University of South Carolina
Charleston
Ralph H Johnson VA Medical Center
Charleston
Prisma Health Cancer Institute - Laurens
Clinton
Prisma Health Cancer Institute - Easley
Easley
Gibbs Cancer Center-Gaffney
Gaffney
Prisma Health Cancer Institute - Butternut
Greenville
Prisma Health Cancer Institute - Eastside
Greenville
Prisma Health Cancer Institute - Faris
Greenville
Saint Francis Cancer Center
Greenville
Saint Francis Hospital
Greenville
Gibbs Cancer Center-Pelham
Greer
Prisma Health Cancer Institute - Greer
Greer
Prisma Health Cancer Institute - Seneca
Seneca
Spartanburg Medical Center
Spartanburg
Lexington Medical Center
West Columbia
Tennessee
Meharry Medical College
Nashville
Vanderbilt University/Ingram Cancer Center
Nashville
Texas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth
University of Texas Medical Branch
Galveston
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston
Ben Taub General Hospital
Houston
UTMB Cancer Center at Victory Lakes
League City
UT Southwestern Clinical Center at Richardson/Plano
Richardson
Audie L Murphy VA Hospital
San Antonio
University of Texas Health Science Center at San Antonio
San Antonio
Utah
Farmington Health Center
Farmington
Huntsman Cancer Institute/University of Utah
Salt Lake City
South Jordan Health Center
South Jordan
Virginia
University of Virginia Cancer Center
Charlottesville
Sovah Health Martinsville
Martinsville
Bon Secours Memorial Regional Medical Center
Mechanicsville
Bon Secours Saint Francis Medical Center
Midlothian
Bon Secours Saint Mary's Hospital
Richmond
Virginia Commonwealth University/Massey Cancer Center
Richmond
Vermont
Central Vermont Medical Center/National Life Cancer Treatment
Berlin
University of Vermont and State Agricultural College
Burlington
University of Vermont Medical Center
Burlington
Washington
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton
Kadlec Clinic Hematology and Oncology
Kennewick
FHCC South Lake Union
Seattle
Fred Hutchinson Cancer Research Center
Seattle
University of Washington Medical Center - Montlake
Seattle
Wisconsin
Langlade Hospital and Cancer Center
Antigo
ThedaCare Regional Cancer Center
Appleton
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield
Aurora Cancer Care-Southern Lakes VLCC
Burlington
Marshfield Medical Center-EC Cancer Center
Eau Claire
Aurora Health Center-Fond du Lac
Fond Du Lac
Ascension Saint Francis - Reiman Cancer Center
Franklin
Aurora Health Care Germantown Health Center
Germantown
Aurora Cancer Care-Grafton
Grafton
Aurora BayCare Medical Center
Green Bay
UW Cancer Center Johnson Creek
Johnson Creek
Aurora Cancer Care-Kenosha South
Kenosha
University of Wisconsin Carbone Cancer Center
Madison
William S Middleton VA Medical Center
Madison
Aurora Bay Area Medical Group-Marinette
Marinette
Marshfield Medical Center-Marshfield
Marshfield
Aspirus Medford Hospital
Medford
Aurora Cancer Care-Milwaukee
Milwaukee
Aurora Saint Luke's Medical Center
Milwaukee
Aurora Sinai Medical Center
Milwaukee
Medical College of Wisconsin
Milwaukee
Marshfield Clinic-Minocqua Center
Minocqua
ProHealth D N Greenwald Center
Mukwonago
ProHealth Oconomowoc Memorial Hospital
Oconomowoc
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh
Aurora Cancer Care-Racine
Racine
Marshfield Medical Center-Rice Lake
Rice Lake
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan
Marshfield Medical Center-River Region at Stevens Point
Stevens Point
Aurora Medical Center in Summit
Summit
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers
ProHealth Waukesha Memorial Hospital
Waukesha
UW Cancer Center at ProHealth Care
Waukesha
Aspirus Regional Cancer Center
Wausau
Marshfield Clinic-Wausau Center
Wausau
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa
Aurora Cancer Care-Milwaukee West
Wauwatosa
Aurora West Allis Medical Center
West Allis
Marshfield Medical Center - Weston
Weston
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids
Other Locations
Canada
Tom Baker Cancer Centre
Calgary
Cross Cancer Institute
Edmonton
QEII Health Sciences Centre/Nova Scotia Health Authority
Halifax
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton
Saint Joseph's Healthcare Charlton Campus
Hamilton
Kingston Health Sciences Centre
Kingston
London Regional Cancer Program
London
The Moncton Hospital
Moncton
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal
Niagara Health System-Saint Catharines General
Saint Catharines
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto
University Health Network-Princess Margaret Hospital
Toronto
Windsor Regional Cancer Centre
Windsor
CancerCare Manitoba
Winnipeg
Israel
Rambam Medical Center
Haifa
Shaare Zedek Medical Center
Jerusalem
Time Frame
Start Date: February 2, 2017
Estimated Completion Date: November 30, 2023
Participants
Target number of participants: 766
Treatments
Experimental: Arm I (nivolumab, 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.
Active Comparator: Arm II (nephrectomy)
Patients undergo partial or radical nephrectomy within 8 weeks after registration followed by observation.
Authors
Rana R. McKay, Joel Picus, Dennis E. Slater, Leonard J. Seigel, Katie S. Murray, Ari D. Baron, Yeun-Hee A. Park, Robert A. Zaiden, Robert Dreicer, Gretchen A. Gignac, Stephanie A. Berg, Jonathan S. Treisman, Anil Kapoor, Vivek K. Narayan, Sumanta K. Pal, Rinah I. Shopnick, Antony Ruggeri, Naveen S. Basappa, Ralph J. Hauke, Paromita Datta, Thomas H. Openshaw, Scott E. Delacroix, Gennady Bratslavsky, Krishna S. Gunturu, Michael E. Hurwitz, Arjun V. Balar, Philip J. Stella, Michael Kahn, Bryan A. Faller, Dan Costin, Michael Humeniuk, Jeffrey M. Kamradt, Preston D. Steen, Rex B. Mowat, Sreedhar Katragadda, Michael S. Steinberg, Roberto Pili, Mohamad Allaf, Jeffrey A. Sosman, Santosh Rao, Jacek Pinski, Howard M. Gross, Jay W. Carlson, Harsha V. Poola, Elaine T. Lam, Joseph Sokhn, Vamsi K. Vasireddy, Mehmet S. Copur, Joseph J. Merchant, William J. Irvin, Sugandh D. Shetty, Marc R. Matrana, Arnab Basu, Timothy R. Wassenaar, Nicholas E. Power, Naveed A. Rana, David D. Chism, Scott D. Perrapato, Ronald P. Kaufman, Hamid Emamekhoo, Donald J. Jurgens, Nataliya Mar, Sarah J. Sinclair, Jeffrey K. Giguere, Brian C. Myre, Anthony D. Elias, Anthony E. Mega, Timothy J. Daskivich, Brian A. Costello, Paul M. Barr, John M. Schallenkamp, Ding Wang, Wayne B. Harris, James N. Atkins, Geetika Srivastava, Mehmood H. Hashmi, Nibal Saad, Pooja Ghatalia, Alison D. Savage, Nagesh H. Jayaram, Helen H. Moon, John C. Henegan, Prateek Mendiratta, Hana F. Safah, Sarah P. Psutka, Michael A. Liss, Dhiren S. Dave, Abhinav Sidana, Mohammed Saad, Christopher W. Ryan, Jeffrey Crawford, Monika Joshi, Dustin E. Stevenson, Brian W. Cross, Steven A. Madden, Elizabeth Henry, Einar F. Sverrisson, Henry T. Tsai, Donald F. Busiek, Lori A. Wood, Puja Nistala, Ross E. Krasnow, Alison K. Conlin, Asit K. Paul, Robert D. Siegel, Misbah U. Qadir, Antonio F. Muina, Kriti Mittal, Harish G. Ahuja, Lisa S. Wang, Terrence P. Cescon, Debra M. Prow, Benjamin A. Gartrell, Thomas P. Bradley, Anibal Drelichman, Kara N. Babaian, Philip E. Lammers, Brian Shuch, Stephen J. Savage, Sharon D. Luikart, Nabil Adra, Deepak Kilari, Timothy M. Kuzel, Anne K. Schuckman, Viraj Master, Bradley A. McGregor, Jennifer M. Suga, Brian A. DiCarlo, David S. Hanson, John C. Morris, Timothy S. Collins, Brian Dietrich, Peng Wang, Ana M. Molina, Leonard J. Gitter, Matthew I. Milowsky, Vitaly Margulis, Liam C. Macleod, Rommel P. Lu, Ari H. Elman, Jonathan A. Chatzkel, Uzair B. Chaudhary, Jianqing Lin, Devika G. Das, James L. Wade, Michael L. Cher, Benjamin T. Marchello, Peter Rubin, Tracy L. Rose, Augusto C. Ochoa, Sandeep H. Mashru, Zhentao Zhang, Warren L. Robinson, David Kosoff, Peter Hinds, Leonard J. Appleman, Daniel Moreira, Bradley T. Clifford, Heinric Williams, Ajjai S. Alva, Ulka N. Vaishampayan, Richard L. Deming, Walter M. Stadler, Aihua E. Yen, David M. King, Michael A. Carducci, Charles O. Kim, Sarah Ali, Pedro M. Barata, Michael M. Goodman, Bagi R. Jana, Suliman Boulos, Bruno Nahar Aragao de Oliveira, Jue Wang, Gleb Kornev, Daniel Y. Heng, Mahmoud Abdelsalam, Nancy B. Davis, Benjamin R. Lee, Michel Pavic, Sandy Srinivas, Jeffrey Graham, Christopher J. Hoimes, Primo N. Lara, Michael A. Levesque, Eric A. Singer, Sebastien J. Hotte, Elizabeth M. Wulff-Burchfield, Jean-Baptiste Lattouf, Antonio Finelli, Brock O'Neil, Kathleen J. Yost, John A. Ellerton, Demet G. Yasar, Sindu M. Kanjeekal, Lauren C. Harshman, Avivit Peer, Mazyar Ghanaat, Robert S. Alter, William Tse, Martin Smoragiewicz, Francisco E. Vera Badillo, Neeharika Srivastava Makani
Sponsors
Collaborators: Canadian Cancer Trials Group
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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