Clinical Trial - NCT03055013

Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy

Recruiting

Sponsor: National Cancer Institute (NCI)

Collaborators: Canadian Cancer Trials Group

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03055013

Protocol Info

Short Description: NIVOLUMAB VS OBSERVATION IN RENAL CELL CARCINOMA
Long Description: ECOG-ACRIN EA8143, A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)
MGH Status: Open
Sponsor: Coop/ECOG
Disease Program: GU

Next Steps


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Purpose

This phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney) with or without nivolumab in treating patients with kidney cancer that is limited to a certain part of the body (localized). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab before nephrectomy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed, and after nephrectomy to increase survival. It is not yet known whether nivolumab and nephrectomy is more effective than nephrectomy alone in treating patients with kidney cancer.
Condition Title Intervention Phase
Metastatic Malignant Neoplasm in Lymph Node Metastatic Malignant Neoplasm in the Adrenal Gland Metastatic Malignant Neoplasm in the Lung Metastatic Malignant Neoplasm in the Pancreas Metastatic Malignant Neoplasm in the Skin Metastatic Malignant Neoplasm in the Soft Tissues Metastatic Renal Cell Carcinoma Oligometastasis Sarcomatoid Renal Cell Carcinoma Stage II Renal Cell Cancer AJCC v7 Stage III Renal Cell Cancer AJCC v7 Unclassified Renal Cell Carcinoma Conventional Surgery Nivolumab Patient Observation Quality-of-Life Assessment Questionnaire Administration Phase 3
Study Type Interventional
Official Title A Phase 3 Randomized Study Comparing Perioperative Nivolumab vs. Observation in Patients With Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

Primary Outcome Measures

Recurrence-free survival (RFS) [Time Frame: Time from randomization to disease recurrence or death from any cause, assessed up to 10 years] [Designated as safety issue: ]


Secondary Outcome Measures

Overall survival [Time Frame: Time from randomization to death from any cause, assessed up to 10 years] [Designated as safety issue: ]

RFS among patients with clear cell cancer [Time Frame: Up to 10 years] [Designated as safety issue: ]

Incidence of toxicity [Time Frame: Up to 10 years] [Designated as safety issue: ]

Estimated Enrollment: 805
Study Start Date: February 2017
Estimated Study Completion Date: November 2023
Estimated Primary Completion Date: November 2023
Arms Assigned Interventions

Experimental:Arm I (nivolumab, nephrectomy)

Patients receive nivolumab IV over 30-60 minutes on day 1. Treatment repeats every 14 days for 2 cycles. Patients then undergo partial or radical nephrectomy 7-28 days later. Patient then receive nivolumab over 30-60 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 30-60 minutes on day 1. Patients then undergo partial or radical nephrectomy 7-28 days later. Patient then receive nivolumab IV over 30-60 minutes on day 1. Treatment repeats every 4 weeks for 9 cycles in the absence of disease progression or unacceptable toxicity.
Other:Questionnaire Administration
Ancillary studies

Active Comparator:Arm II (nephrectomy)

ARM II: Patients undergo partial or radical nephrectomy within 8 weeks after registration followed by observation.
Other:Patient Observation
Undergo observation

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria:

  • ELIGIBILITY CRITERIA FOR PREREGISTRATION (STEP 0):
  • Patients with 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 can be resected/definitively treated (e.g., thermal ablation, stereotactic radiation) at the same time or within a 12 week window from the date of the initial procedure such that the patient is considered "no evidence of disease" (M1 NED)
  • Permitted sites of oligo-metastases: lung, adrenal, nodes, pancreas, soft tissue or skin; liver or bone 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 pre-registration (Step 0), patient must be willing to undergo a core biopsy for this purpose if randomized to Arm H
  • NOTE: This can be a (1) standard of care diagnostic biopsy or (2) a research biopsy following assignment to Arm H or a planned metastasectomy before or after randomization; if the biopsy performed following pre-registration (Step 0) clearly demonstrates a benign condition, oncocytoma or a different type of cancer that is not RCC, the patient is not eligible for registration (Step 1); 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
  • NOTE: Patients randomized to Arm O (Observation) are permitted to register to Step 1 (Arm B) immediately following pre-registration assignment to Arm O, regardless of whether or not they have had a standard of care diagnostic biopsy
  • No prior systemic or local anti-cancer therapy for the current RCC is permitted
  • Partial nephrectomy for prior RCC
  • Metastasectomy for the current RCC diagnosis is not allowed unless performed to render patient NED (in addition to the planned nephrectomy) within 6 months of the current diagnosis
  • Radiation therapyto the bilateral kidney or any distant metastatic sites, is not allowed unless administered to render patient NED within 6 months of the current diagnosis
  • Current or past antineoplastic systemic therapies for RCC are not allowed: i.e., chemotherapy, hormonal therapy, immunotherapy, or standard or investigational agents for treatment of RCC
  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1
  • Patient must have no prior history of RCC that was resected 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 completely removed and subsequent hemodialysis is required
  • Permitted forms of local therapy for second tumor:
  • Partial or radical nephrectomy
  • If tumor is =< 3cm: 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 pre-registration 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
  • No active known or suspected autoimmune disease; the following autoimmune disorders are permitted: patients with vitiligo, type I diabetes mellitus, controlled/stable hypothyroidism due to autoimmune or non-autoimmune conditions (hormone replacement is allowed), psoriasis not requiring systemic treatment, or other conditions not expected to recur
  • No ongoing condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications with the exceptions outlined below; no 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
  • No uncontrolled adrenal insufficiency
  • No known chronic active liver disease or evidence of acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • No serious intercurrent illness, including ongoing or active infection requiring parenteral antibodies
  • No known evidence of human immunodeficiency virus (HIV) infection, since the effects of nivolumab on anti-retroviral therapy have not been studied
  • No 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
  • No major surgery within 28 days prior to randomization
  • No patients currently enrolled in other clinical trials testing a therapeutic intervention
  • No history of severe hypersensitivity to a monoclonal antibody
  • Ability to understand and the willingness to sign a written informed consent document
  • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1):
  • Patients must meet all Step 0 eligibility criteria at the time of their registration to Step 1
  • In patients randomized to Arm H, core tumor biopsy must demonstrate RCC of any histology, including sarcomatoid, unclassified, or "unknown histology" (if preoperative biopsy was uninformative)
  • NOTE: 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
  • Women 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 females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is 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 2) 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)
  • Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must use accepted and effective method(s) of contraception, or to abstain from sexual intercourse for the duration of their participation in the study; women of childbearing potential must use adequate methods to avoid pregnancy for 23 weeks after the last dose of nivolumab; sexually active males must use adequate methods to avoid pregnancy for 31 weeks after the last dose of nivolumab
  • White blood cells >= 2000/uL (within 8 weeks of registration)
  • Absolute neutrophil count (ANC) >= 1,500/mm^3 (within 8 weeks of registration)
  • Platelet count >= 100,000/mm^3 (within 8 weeks of registration)
  • Hemoglobin >= 9.0 g/dL (within 8 weeks of registration)
  • Serum creatinine =< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 x ULN) (within 8 weeks of registration)
  • Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 x ULN) (within 8 weeks of registration)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN (within 8 weeks of registration)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03055013

Locations

  • United States, Arizona
    • University of Arizona Cancer Center at Saint Joseph's Phoenix, Arizona, United States, 85004
    • Banner University Medical Center - Tucson Tucson, Arizona, United States, 85719
    • University of Arizona Cancer Center-North Campus Tucson, Arizona, United States, 85719
  • United States, California
    • Kaiser Permanente-Anaheim Anaheim, California, United States, 92806
    • Sutter Auburn Faith Hospital Auburn, California, United States, 95602
    • AIS Cancer Center at San Joaquin Community Hospital Bakersfield, California, United States, 93301
    • Kaiser Permanente-Baldwin Park Baldwin Park, California, United States, 91706
    • Kaiser Permanente-Bellflower Bellflower, California, United States, 90706
    • Alta Bates Summit Medical Center-Herrick Campus Berkeley, California, United States, 94704
    • Kaiser Permanente-Fontana Fontana, California, United States, 92335
    • Kaiser Permanente - Harbor City Harbor City, California, United States, 90710
    • Kaiser Permanente-Irvine Irvine, California, United States, 92618
    • UC San Diego Moores Cancer Center La Jolla, California, United States, 92093
    • Kaiser Permanente Los Angeles Medical Center Los Angeles, California, United States, 90027
    • USC / Norris Comprehensive Cancer Center Los Angeles, California, United States, 90033
    • Kaiser Permanente-Cadillac Los Angeles, California, United States, 90034
    • Cedars Sinai Medical Center Los Angeles, California, United States, 90048
    • UCLA / Jonsson Comprehensive Cancer Center Los Angeles, California, United States, 90095
    • Fremont - Rideout Cancer Center Marysville, California, United States, 95901
    • Palo Alto Medical Foundation-Camino Division Mountain View, California, United States, 94040
    • Kaiser Permanente-Oakland Oakland, California, United States, 94611
    • Kaiser Permanente-Ontario Ontario, California, United States, 91761
    • Palo Alto Medical Foundation Health Care Palo Alto, California, United States, 94301
    • Kaiser Permanente - Panorama City Panorama City, California, United States, 91402
    • Eisenhower Medical Center Rancho Mirage, California, United States, 92270
    • Kaiser Permanente-Riverside Riverside, California, United States, 92505
    • Kaiser Permanente-Roseville Roseville, California, United States, 95661
    • Sutter Roseville Medical Center Roseville, California, United States, 95661
    • Kaiser Permanente Downtown Commons Sacramento, California, United States, 95814
    • Sutter Medical Center Sacramento Sacramento, California, United States, 95816
    • University of California Davis Comprehensive Cancer Center Sacramento, California, United States, 95817
    • Kaiser Permanente - Sacramento Sacramento, California, United States, 95825
    • Kaiser Permanente-San Diego Zion San Diego, California, United States, 92120
    • California Pacific Medical Center-Pacific Campus San Francisco, California, United States, 94115
    • Kaiser Permanente-San Francisco San Francisco, California, United States, 94115
    • Kaiser Permanente-Santa Teresa-San Jose San Jose, California, United States, 95119
    • Kaiser Permanente San Leandro San Leandro, California, United States, 94577
    • Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California, United States, 93401
    • Kaiser Permanente-San Marcos San Marcos, California, United States, 92078
    • Kaiser Permanente Medical Center - Santa Clara Santa Clara, California, United States, 95051
    • Palo Alto Medical Foundation-Santa Cruz Santa Cruz, California, United States, 95065
    • Kaiser Permanente-South San Francisco South San Francisco, California, United States, 94080
    • Palo Alto Medical Foundation-Sunnyvale Sunnyvale, California, United States, 94086
    • Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee, California, United States, 96161
    • Kaiser Permanente-Vallejo Vallejo, California, United States, 94589
    • Sutter Solano Medical Center/Cancer Center Vallejo, California, United States, 94589
    • Kaiser Permanente-Walnut Creek Walnut Creek, California, United States, 94596
    • Presbyterian Intercommunity Hospital Whittier, California, United States, 90602
    • Kaiser Permanente-Woodland Hills Woodland Hills, California, United States, 91367
  • United States, Colorado
    • UCHealth Memorial Hospital Central Colorado Springs, Colorado, United States, 80909
    • Poudre Valley Hospital Fort Collins, Colorado, United States, 80524
  • United States, Connecticut
    • Hartford Hospital Hartford, Connecticut, United States, 06102
    • Midstate Medical Center Meriden, Connecticut, United States, 06451
    • The Hospital of Central Connecticut New Britain, Connecticut, United States, 06050
    • Yale University New Haven, Connecticut, United States, 06520
    • Eastern Connecticut Hematology and Oncology Associates Norwich, Connecticut, United States, 06360
  • United States, District of Columbia
    • George Washington University Medical Center Washington, District of Columbia, United States, 20037
  • United States, Florida
    • Holy Cross Hospital Fort Lauderdale, Florida, United States, 33308
    • Baptist MD Anderson Cancer Center Jacksonville, Florida, United States, 32207
    • The Watson Clinic Lakeland, Florida, United States, 33805
  • United States, Georgia
    • Emory University Hospital/Winship Cancer Institute Atlanta, Georgia, United States, 30322
    • Atlanta VA Medical Center Decatur, Georgia, United States, 30033
  • United States, Hawaii
    • Pali Momi Medical Center 'Aiea, Hawaii, United States, 96701
    • Hawaii Cancer Care Inc-POB II Honolulu, Hawaii, United States, 96813
    • Queen's Medical Center Honolulu, Hawaii, United States, 96813
    • Straub Clinic and Hospital Honolulu, Hawaii, United States, 96813
    • Hawaii Oncology Inc-Kuakini Honolulu, Hawaii, United States, 96817
  • United States, Idaho
    • Saint Luke's Mountain States Tumor Institute Boise, Idaho, United States, 83712
    • Saint Luke's Mountain States Tumor Institute - Fruitland Fruitland, Idaho, United States, 83619
    • Saint Luke's Mountain States Tumor Institute - Meridian Meridian, Idaho, United States, 83642
    • Saint Luke's Mountain States Tumor Institute - Nampa Nampa, Idaho, United States, 83686
    • Saint Luke's Mountain States Tumor Institute-Twin Falls Twin Falls, Idaho, United States, 83301
  • United States, Illinois
    • Illinois CancerCare-Bloomington Bloomington, Illinois, United States, 61704
    • Illinois CancerCare-Canton Canton, Illinois, United States, 61520
    • Illinois CancerCare-Carthage Carthage, Illinois, United States, 62321
    • Northwestern University Chicago, Illinois, United States, 60611
    • Rush University Medical Center Chicago, Illinois, United States, 60612
    • University of Chicago Comprehensive Cancer Center Chicago, Illinois, United States, 60637
    • Cancer Care Specialists of Illinois - Decatur Decatur, Illinois, United States, 62526
    • Crossroads Cancer Center Effingham, Illinois, United States, 62401
    • Elmhurst Memorial Hospital Elmhurst, Illinois, United States, 60126
    • Illinois CancerCare-Eureka Eureka, Illinois, United States, 61530
    • Illinois CancerCare-Galesburg Galesburg, Illinois, United States, 61401
    • Northwestern Medicine Cancer Center Delnor Geneva, Illinois, United States, 60134
    • Illinois CancerCare-Kewanee Clinic Kewanee, Illinois, United States, 61443
    • Illinois CancerCare-Macomb Macomb, Illinois, United States, 61455
    • Loyola University Medical Center Maywood, Illinois, United States, 60153
    • Edward Hospital/Cancer Center Naperville, Illinois, United States, 60540
    • Illinois CancerCare-Ottawa Clinic Ottawa, Illinois, United States, 61350
    • Illinois CancerCare-Pekin Pekin, Illinois, United States, 61554
    • Illinois CancerCare-Peoria Peoria, Illinois, United States, 61615
    • Illinois CancerCare-Peru Peru, Illinois, United States, 61354
    • Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois, United States, 60585
    • Illinois CancerCare-Princeton Princeton, Illinois, United States, 61356
    • Springfield Clinic Springfield, Illinois, United States, 62702
    • Cancer Care Specialists of Illinois-Swansea Swansea, Illinois, United States, 62226
    • Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois, United States, 60555
  • United States, Indiana
    • Parkview Regional Medical Center Fort Wayne, Indiana, United States, 46845
    • Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana, United States, 46202
    • Sidney and Lois Eskenazi Hospital Indianapolis, Indiana, United States, 46202
    • Franciscan Health Indianapolis Indianapolis, Indiana, United States, 46237
    • Franciscan Health Mooresville Mooresville, Indiana, United States, 46158
    • Reid Health Richmond, Indiana, United States, 47374
  • United States, Iowa
    • Mary Greeley Medical Center Ames, Iowa, United States, 50010
    • McFarland Clinic PC - Ames Ames, Iowa, United States, 50010
    • McFarland Clinic PC-Boone Boone, Iowa, United States, 50036
    • Medical Oncology and Hematology Associates-West Des Moines Clive, Iowa, United States, 50325
    • Mercy Cancer Center-West Lakes Clive, Iowa, United States, 50325
    • Medical Oncology and Hematology Associates-Laurel Des Moines, Iowa, United States, 50314
    • Mercy Medical Center - Des Moines Des Moines, Iowa, United States, 50314
    • McFarland Clinic PC-Trinity Cancer Center Fort Dodge, Iowa, United States, 50501
    • McFarland Clinic PC-Jefferson Jefferson, Iowa, United States, 50129
    • McFarland Clinic PC-Marshalltown Marshalltown, Iowa, United States, 50158
    • Mercy Medical Center-West Lakes West Des Moines, Iowa, United States, 50266
  • United States, Kansas
    • Hays Medical Center Hays, Kansas, United States, 67601
    • University of Kansas Cancer Center Kansas City, Kansas, United States, 66160
    • Olathe Medical Center Olathe, Kansas, United States, 66061
    • University of Kansas Cancer Center-Overland Park Overland Park, Kansas, United States, 66210
    • Via Christi Hospital-Pittsburg Pittsburg, Kansas, United States, 66762
    • Salina Regional Health Center Salina, Kansas, United States, 67401
    • Saint Francis Hospital and Medical Center - Topeka Topeka, Kansas, United States, 66606
    • University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas, United States, 66205
  • United States, Kentucky
    • University of Kentucky/Markey Cancer Center Lexington, Kentucky, United States, 40536
  • United States, Louisiana
    • LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana, United States, 70805
    • Louisiana Hematology Oncology Associates LLC Baton Rouge, Louisiana, United States, 70809
    • Mary Bird Perkins Cancer Center Baton Rouge, Louisiana, United States, 70809
    • Our Lady of the Lake Physicians Group - Medical Oncology Baton Rouge, Louisiana, United States, 70809
    • Northshore Oncology Associates-Covington Covington, Louisiana, United States, 70433
    • Oncology Center of The South Incorporated Houma, Louisiana, United States, 70360
    • East Jefferson General Hospital Metairie, Louisiana, United States, 70006
    • Louisiana State University Health Science Center New Orleans, Louisiana, United States, 70112
    • Ochsner Medical Center Jefferson New Orleans, Louisiana, United States, 70121
    • Louisiana State University Health Sciences Center Shreveport Shreveport, Louisiana, United States, 71103
  • United States, Maine
    • Harold Alfond Center for Cancer Care Augusta, Maine, United States, 04330
    • Eastern Maine Medical Center Bangor, Maine, United States, 04401
    • Waldo County General Hospital Belfast, Maine, United States, 04915
    • MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford, Maine, United States, 04005
    • Lafayette Family Cancer Center-EMMC Brewer, Maine, United States, 04412
    • Penobscot Bay Medical Center Rockport, Maine, United States, 04856
    • MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford, Maine, United States, 04073
    • Maine Medical Partners - South Portland South Portland, Maine, United States, 04106
  • United States, Maryland
    • Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland, United States, 21287
  • United States, Massachusetts
    • Massachusetts General Hospital Cancer Center Boston, Massachusetts, United States, 02114
    • Brigham and Women's Hospital Boston, Massachusetts, United States, 02115
    • Boston Medical Center Boston, Massachusetts, United States, 02118
    • Beth Israel Deaconess Medical Center Boston, Massachusetts, United States, 02215
    • Dana-Farber Cancer Institute Boston, Massachusetts, United States, 02215
    • Lahey Hospital and Medical Center Burlington, Massachusetts, United States, 01805
    • Simonds-Sinon Regional Cancer Center Fitchburg, Massachusetts, United States, 01420
    • Winchester Hospital Winchester, Massachusetts, United States, 01890
    • University of Massachusetts Medical School Worcester, Massachusetts, United States, 01655
  • United States, Michigan
    • Saint Joseph Mercy Hospital Ann Arbor, Michigan, United States, 48106
    • University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan, United States, 48109
    • Saint Joseph Mercy Brighton Brighton, Michigan, United States, 48114
    • Saint Joseph Mercy Canton Canton, Michigan, United States, 48188
    • Saint Joseph Mercy Chelsea Chelsea, Michigan, United States, 48118
    • Wayne State University/Karmanos Cancer Institute Detroit, Michigan, United States, 48201
    • Weisberg Cancer Treatment Center Farmington Hills, Michigan, United States, 48334
    • Sparrow Hospital Lansing, Michigan, United States, 48912
    • William Beaumont Hospital-Royal Oak Royal Oak, Michigan, United States, 48073
    • William Beaumont Hospital - Troy Troy, Michigan, United States, 48085
  • United States, Minnesota
    • Minneapolis VA Medical Center Minneapolis, Minnesota, United States, 55417
    • Mayo Clinic Rochester, Minnesota, United States, 55905
  • United States, Mississippi
    • Gulfport Memorial Hospital Gulfport, Mississippi, United States, 39502
    • University of Mississippi Medical Center Jackson, Mississippi, United States, 39216
  • United States, Missouri
    • Saint Francis Medical Center Cape Girardeau, Missouri, United States, 63703
    • University of Missouri - Ellis Fischel Columbia, Missouri, United States, 65212
    • Siteman Cancer Center at West County Hospital Creve Coeur, Missouri, United States, 63141
    • Truman Medical Center Kansas City, Missouri, United States, 64108
    • The University of Kansas Cancer Center-Lee's Summit Lee's Summit, Missouri, United States, 64064
    • Washington University School of Medicine Saint Louis, Missouri, United States, 63110
    • Siteman Cancer Center at Saint Peters Hospital Saint Peters, Missouri, United States, 63376
  • United States, Montana
    • Bozeman Deaconess Hospital Bozeman, Montana, United States, 59715
    • Benefis Healthcare- Sletten Cancer Institute Great Falls, Montana, United States, 59405
  • United States, Nebraska
    • CHI Health Saint Francis Grand Island, Nebraska, United States, 68803
    • Nebraska Methodist Hospital Omaha, Nebraska, United States, 68114
  • United States, Nevada
    • OptumCare Cancer Care at Fort Apache Las Vegas, Nevada, United States, 89148
    • Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada, United States, 89169
    • University Cancer Center Las Vegas, Nevada, United States, 89169
    • Renown Regional Medical Center Reno, Nevada, United States, 89502
  • United States, New Jersey
    • Hackensack University Medical Center Hackensack, New Jersey, United States, 07601
    • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey, United States, 08903
    • Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey, United States, 08903
  • United States, New York
    • Montefiore Medical Center-Einstein Campus Bronx, New York, United States, 10461
    • Montefiore Medical Center-Weiler Hospital Bronx, New York, United States, 10461
    • Montefiore Medical Center - Moses Campus Bronx, New York, United States, 10467
    • James J Peters VA Medical Center Bronx, New York, United States, 10468
    • Glens Falls Hospital Glens Falls, New York, United States, 12801
    • Northwell Health/Center for Advanced Medicine Lake Success, New York, United States, 11042
    • Long Island Jewish Medical Center New Hyde Park, New York, United States, 11040
    • NYP/Weill Cornell Medical Center New York, New York, United States, 10065
    • Dickstein Cancer Treatment Center White Plains, New York, United States, 10601
  • United States, North Carolina
    • UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina, United States, 27599
    • Southeastern Medical Oncology Center-Clinton Clinton, North Carolina, United States, 28328
    • Duke University Medical Center Durham, North Carolina, United States, 27710
    • Southeastern Medical Oncology Center-Goldsboro Goldsboro, North Carolina, United States, 27534
    • Wayne Memorial Hospital Goldsboro, North Carolina, United States, 27534
    • Onslow Memorial Hospital Jacksonville, North Carolina, United States, 28546
    • Southeastern Medical Oncology Center-Jacksonville Jacksonville, North Carolina, United States, 28546
    • Vidant Oncology-Kenansville Kenansville, North Carolina, United States, 28349
    • Vidant Oncology-Kinston Kinston, North Carolina, United States, 28501
    • Vidant Oncology-Richlands Richlands, North Carolina, United States, 28574
    • Wake Forest University Health Sciences Winston-Salem, North Carolina, United States, 27157
  • United States, North Dakota
    • Sanford Bismarck Medical Center Bismarck, North Dakota, United States, 58501
    • Sanford Broadway Medical Center Fargo, North Dakota, United States, 58122
    • Sanford Roger Maris Cancer Center Fargo, North Dakota, United States, 58122
  • United States, Ohio
    • University of Cincinnati/Barrett Cancer Center Cincinnati, Ohio, United States, 45219
    • Good Samaritan Hospital - Cincinnati Cincinnati, Ohio, United States, 45220
    • Bethesda North Hospital Cincinnati, Ohio, United States, 45242
    • Kettering Medical Center Kettering, Ohio, United States, 45429
    • Toledo Clinic Cancer Centers-Toledo Toledo, Ohio, United States, 43623
    • University Pointe West Chester, Ohio, United States, 45069
  • United States, Oklahoma
    • University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma, United States, 73104
    • Mercy Hospital Oklahoma City Oklahoma City, Oklahoma, United States, 73120
  • United States, Oregon
    • Providence Oncology and Hematology Care Southeast Clackamas, Oregon, United States, 97015
    • Providence Newberg Medical Center Newberg, Oregon, United States, 97132
    • Providence Willamette Falls Medical Center Oregon City, Oregon, United States, 97045
    • Providence Portland Medical Center Portland, Oregon, United States, 97213
    • Providence Saint Vincent Medical Center Portland, Oregon, United States, 97225
    • Kaiser Permanente Northwest Portland, Oregon, United States, 97227
  • United States, Pennsylvania
    • Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania, United States, 18103
    • Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania, United States, 18017
    • Geisinger Medical Center Danville, Pennsylvania, United States, 17822
    • Penn State Milton S Hershey Medical Center Hershey, Pennsylvania, United States, 17033-0850
    • University of Pennsylvania/Abramson Cancer Center Philadelphia, Pennsylvania, United States, 19104
    • University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania, United States, 15232
    • Reading Hospital West Reading, Pennsylvania, United States, 19611
    • UPMC Susquehanna Williamsport, Pennsylvania, United States, 17701
  • United States, Rhode Island
    • Rhode Island Hospital Providence, Rhode Island, United States, 02903
    • Miriam Hospital Providence, Rhode Island, United States, 02906
  • United States, South Carolina
    • Medical University of South Carolina Charleston, South Carolina, United States, 29425
    • Greenville Health System Cancer Institute-Laurens Clinton, South Carolina, United States, 29325
    • Greenville Health System Cancer Institute-Easley Easley, South Carolina, United States, 29640
    • Saint Francis Hospital Greenville, South Carolina, United States, 29601
    • Greenville Health System Cancer Institute-Butternut Greenville, South Carolina, United States, 29605
    • Greenville Health System Cancer Institute-Faris Greenville, South Carolina, United States, 29605
    • Saint Francis Cancer Center Greenville, South Carolina, United States, 29607
    • Greenville Health System Cancer Institute-Eastside Greenville, South Carolina, United States, 29615
    • Greenville Health System Cancer Institute-Greer Greer, South Carolina, United States, 29650
    • Greenville Health System Cancer Institute-Seneca Seneca, South Carolina, United States, 29672
    • Greenville Health System Cancer Institute-Spartanburg Spartanburg, South Carolina, United States, 29307
  • United States, Tennessee
    • Meharry Medical College Nashville, Tennessee, United States, 37208
    • Vanderbilt University/Ingram Cancer Center Nashville, Tennessee, United States, 37232
  • United States, Texas
    • UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas, United States, 75390
    • UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth, Texas, United States, 76104
    • University of Texas Medical Branch Galveston, Texas, United States, 77555-0565
    • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas, United States, 77030
    • Ben Taub General Hospital Houston, Texas, United States, 77030
    • UTMB Cancer Center at Victory Lakes League City, Texas, United States, 77573
    • UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas, United States, 75080
    • University of Texas Health Science Center at San Antonio San Antonio, Texas, United States, 78229
  • United States, Utah
    • Farmington Health Center Farmington, Utah, United States, 84025
    • Huntsman Cancer Institute/University of Utah Salt Lake City, Utah, United States, 84112
    • South Jordan Health Center South Jordan, Utah, United States, 84009
  • United States, Vermont
    • Central Vermont Medical Center/National Life Cancer Treatment Berlin, Vermont, United States, 05602
    • University of Vermont Medical Center Burlington, Vermont, United States, 05401
    • University of Vermont and State Agricultural College Burlington, Vermont, United States, 05405
  • United States, Virginia
    • Sovah Health Martinsville Martinsville, Virginia, United States, 24115
  • United States, Wisconsin
    • Langlade Hospital and Cancer Center Antigo, Wisconsin, United States, 54409
    • Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin, United States, 53105
    • Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin, United States, 54701
    • Aurora Health Center-Fond du Lac Fond Du Lac, Wisconsin, United States, 54937
    • Aurora Health Care Germantown Health Center Germantown, Wisconsin, United States, 53022
    • Aurora Cancer Care-Grafton Grafton, Wisconsin, United States, 53024
    • Aurora BayCare Medical Center Green Bay, Wisconsin, United States, 54311
    • UW Cancer Center Johnson Creek Johnson Creek, Wisconsin, United States, 53038
    • Aurora Cancer Care-Kenosha South Kenosha, Wisconsin, United States, 53142
    • University of Wisconsin Hospital and Clinics Madison, Wisconsin, United States, 53792
    • Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin, United States, 54143
    • Marshfield Medical Center-Marshfield Marshfield, Wisconsin, United States, 54449
    • Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin, United States, 53209
    • Aurora Saint Luke's Medical Center Milwaukee, Wisconsin, United States, 53215
    • Froedtert and the Medical College of Wisconsin Milwaukee, Wisconsin, United States, 53226
    • Aurora Sinai Medical Center Milwaukee, Wisconsin, United States, 53233
    • Marshfield Clinic-Minocqua Center Minocqua, Wisconsin, United States, 54548
    • ProHealth D N Greenwald Center Mukwonago, Wisconsin, United States, 53149
    • ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin, United States, 53066
    • Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin, United States, 54904
    • Aurora Cancer Care-Racine Racine, Wisconsin, United States, 53406
    • Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin, United States, 54868
    • Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin, United States, 53081
    • Marshfield Clinic Stevens Point Center Stevens Point, Wisconsin, United States, 54482
    • Aurora Medical Center in Summit Summit, Wisconsin, United States, 53066
    • Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin, United States, 54241
    • ProHealth Waukesha Memorial Hospital Waukesha, Wisconsin, United States, 53188
    • UW Cancer Center at ProHealth Care Waukesha, Wisconsin, United States, 53188
    • Aspirus Regional Cancer Center Wausau, Wisconsin, United States, 54401
    • Marshfield Clinic-Wausau Center Wausau, Wisconsin, United States, 54401
    • Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin, United States, 53226
    • Aurora West Allis Medical Center West Allis, Wisconsin, United States, 53227
    • Marshfield Clinic - Weston Center Weston, Wisconsin, United States, 54476
    • Aspirus UW Cancer Center Wisconsin Rapids, Wisconsin, United States, 54494
  • Israel,
    • Rambam Medical Center Haifa, , Israel, 31096
    • Shaare Zedek Medical Center Jerusalem, , Israel, 91031

Sponsors and Collaborators

National Cancer Institute (NCI)

Canadian Cancer Trials Group

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03055013
Other Study ID Numbers: NCI-2016-00326
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Carcinoma

Neoplasms

Carcinoma, Renal Cell

Neoplasms, Second Primary

Lung Neoplasms

Skin Neoplasms

Nivolumab

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on May 30, 2019