Kidney Cancer

EA8143 / PROSPER RCC



Nivolumab in Treating Patients with Localized Kidney Cancer Undergoing Nephrectomy

STATUS: Closed to Accrual


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 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)

Canada
Alberta
Calgary
Tom Baker Cancer Centre
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Edmonton
Cross Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Manitoba
Winnipeg
CancerCare Manitoba
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ctu_web@cancercare.mb.ca

New Brunswick
Moncton
The Moncton Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Nova Scotia
Halifax
QEII Health Sciences Centre / Nova Scotia Health Authority
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Ontario
Hamilton
Juravinski Cancer Centre at Hamilton Health Sciences
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Saint Joseph's Healthcare Charlton Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@stjoes.ca

Kingston
Kingston Health Sciences Centre
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cc-clinicaltrials@kgh.kari.net

London
London Regional Cancer Program
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Saint Catharines
Niagara Health System-Saint Catharines General
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Toronto
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

University Health Network-Princess Margaret Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@uhn.on.ca

Windsor
Windsor Regional Cancer Centre
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Quebec
Montreal
CHUM - Centre Hospitalier de l'Universite de Montreal
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: info.cr.chum@ssss.gouv.qc.ca

Sherbrooke
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: crcinformation.chus@ssss.gouv.qc.ca

Israel
Haifa
Rambam Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: y_rozen@rambam.health.gov.il

Jerusalem
Shaare Zedek Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

United States
AL
Birmingham
University of Alabama at Birmingham Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: tmyrick@uab.edu

Veterans Administration Medical Center - Birmingham
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

AZ
Gilbert
Banner MD Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Phoenix
Cancer Center at Saint Joseph's
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Tucson
Banner University Medical Center - Tucson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: aselegue@email.arizona.edu

University of Arizona Cancer Center-North Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

CA
Anaheim
Kaiser Permanente-Anaheim
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@kp.org

Auburn
Sutter Auburn Faith Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: bernicl@sutterhealth.org

Bakersfield
AIS Cancer Center at San Joaquin Community Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Baldwin Park
Kaiser Permanente-Baldwin Park
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@kp.org

Bellflower
Kaiser Permanente-Bellflower
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@kp.org

Berkeley
Alta Bates Summit Medical Center-Herrick Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: bernicl@sutterhealth.org

Burlingame
Mills-Peninsula Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: bernicl@sutterhealth.org

Clovis
Community Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Duarte
City of Hope Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: becomingapatient@coh.org

Fontana
Kaiser Permanente-Fontana
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@kp.org

Harbor City
Kaiser Permanente - Harbor City
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@kp.org

Irvine
Kaiser Permanente-Irvine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@kp.org

La Jolla
UC San Diego Moores Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancercto@ucsd.edu

Los Angeles
Cedars Sinai Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Kaiser Permanente Los Angeles Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@kp.org

Kaiser Permanente West Los Angeles
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@kp.org

UCLA / Jonsson Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

USC / Norris Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Marysville
Fremont - Rideout Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Mountain View
Palo Alto Medical Foundation-Camino Division
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: bernicl@sutterhealth.org

Newport Beach
USC Norris Oncology / Hematology-Newport Beach
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Oakland
Kaiser Permanente-Oakland
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Kpoct@kp.org

Ontario
Kaiser Permanente-Ontario
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@kp.org

Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ucstudy@uci.edu

Palo Alto
Palo Alto Medical Foundation Health Care
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: bernicl@sutterhealth.org

Stanford Cancer Institute Palo Alto
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ccto-office@stanford.edu

VA Palo Alto Health Care System
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Panorama City
Kaiser Permanente - Panorama City
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@kp.org

Rancho Mirage
Eisenhower Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Riverside
Kaiser Permanente-Riverside
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@kp.org

Roseville
Kaiser Permanente-Roseville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Kpoct@kp.org

Sutter Roseville Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: bernicl@sutterhealth.org

Sacramento
Kaiser Permanente - Sacramento
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Kpoct@kp.org

Kaiser Permanente Downtown Commons
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: kpoct@kp.org

Sutter Medical Center Sacramento
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: bernicl@sutterhealth.org

University of California Davis Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

San Diego
Kaiser Permanente-San Diego Zion
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@kp.org

San Francisco
California Pacific Medical Center-Pacific Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: bernicl@sutterhealth.org

Kaiser Permanente-San Francisco
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Kpoct@kp.org

San Jose
Kaiser Permanente-Santa Teresa-San Jose
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Kpoct@kp.org

San Leandro
Kaiser Permanente San Leandro
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Kpoct@kp.org

San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Diane.DeVos-Schmidt@DignityHealth.org

San Marcos
Kaiser Permanente-San Marcos
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@kp.org

Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Kpoct@kp.org

Santa Cruz
Palo Alto Medical Foundation-Santa Cruz
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: bernicl@sutterhealth.org

South San Francisco
Kaiser Permanente-South San Francisco
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Kpoct@kp.org

Sunnyvale
Palo Alto Medical Foundation-Sunnyvale
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: bernicl@sutterhealth.org

Truckee
Gene Upshaw Memorial Tahoe Forest Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Vallejo
Kaiser Permanente-Vallejo
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Kpoct@kp.org

Sutter Solano Medical Center / Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: bernicl@sutterhealth.org

Walnut Creek
Kaiser Permanente-Walnut Creek
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Kpoct@kp.org

Whittier
Presbyterian Intercommunity Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Woodland Hills
Kaiser Permanente-Woodland Hills
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@kp.org

CO
Aurora
University of Colorado Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Colorado Springs
Memorial Hospital North
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

UCHealth Memorial Hospital Central
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Fort Collins
Cancer Care and Hematology-Fort Collins
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Poudre Valley Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Greeley
UCHealth Greeley Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Loveland
Medical Center of the Rockies
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

CT
Hartford
Hartford Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Meriden
Midstate Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

New Britain
The Hospital of Central Connecticut
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

New Haven
Yale University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: canceranswers@yale.edu

Norwich
Eastern Connecticut Hematology and Oncology Associates
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

DC
Washington
George Washington University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

MedStar Washington Hospital Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Sibley Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: jquiver1@jhmi.edu

FL
Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Fort Lauderdale
Holy Cross Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Gainesville
University of Florida Health Science Center - Gainesville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancer-center@ufl.edu

Jacksonville
Baptist MD Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Lakeland
Lakeland Regional Health Hollis Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

The Watson Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Miami
Miami Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

UM Sylvester Comprehensive Cancer Center at Kendall
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Plantation
UM Sylvester Comprehensive Cancer Center at Plantation
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

GA
Atlanta
Emory University Hospital / Winship Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Decatur
Atlanta VA Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

HI
Aiea
Hawaii Cancer Care - Savio
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Pali Momi Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Honolulu
Hawaii Cancer Care Inc - Waterfront Plaza
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: i.webster@hawaiicancercare.com

Queen's Cancer Cenrer - POB I
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Queen's Cancer Center - Kuakini
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Queen's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Straub Clinic and Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

IA
Ames
Mary Greeley Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

McFarland Clinic PC - Ames
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ksoder@mcfarlandclinic.com

Boone
McFarland Clinic PC-Boone
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

Mercy Cancer Center-West Lakes
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

Des Moines
Medical Oncology and Hematology Associates-Laurel
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

Mercy Medical Center - Des Moines
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Jefferson
McFarland Clinic PC-Jefferson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Marshalltown
McFarland Clinic PC-Marshalltown
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

West Des Moines
Mercy Medical Center-West Lakes
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

ID
Boise
Saint Luke's Cancer Institute - Boise
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: eslinget@slhs.org

Coeur D'Alene
Kootenai Health - Coeur d'Alene
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Fruitland
Saint Luke's Cancer Institute - Fruitland
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: eslinget@slhs.org

Meridian
Saint Luke's Cancer Institute - Meridian
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: eslinget@slhs.org

Nampa
Saint Luke's Cancer Institute - Nampa
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: eslinget@slhs.org

Post Falls
Kootenai Clinic Cancer Services - Post Falls
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Sandpoint
Kootenai Cancer Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: eslinget@slhs.org

IL
Bloomington
Illinois CancerCare-Bloomington
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Canton
Illinois CancerCare-Canton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Carthage
Illinois CancerCare-Carthage
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Chicago
Northwestern University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancer@northwestern.edu

Rush University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical_trials@rush.edu

University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerclinicaltrials@bsd.uchicago.edu

University of Illinois
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Danville
Carle on Vermilion
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Research@carle.com

Decatur
Cancer Care Specialists of Illinois - Decatur
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: rhamrick@dmhhs.org

Effingham
Carle Physician Group-Effingham
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Research@carle.com

Crossroads Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: rhamrick@dmhhs.org

Elmhurst
Elmhurst Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Jrohde@emhc.org

Eureka
Illinois CancerCare-Eureka
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Galesburg
Illinois CancerCare-Galesburg
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Geneva
Northwestern Medicine Cancer Center Delnor
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

Hines
Edward Hines Jr VA Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Kewanee
Illinois CancerCare-Kewanee Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Macomb
Illinois CancerCare-Macomb
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Mattoon
Carle Physician Group-Mattoon / Charleston
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Research@carle.com

Maywood
Loyola University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Naperville
Edward Hospital / Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

O'Fallon
Cancer Care Center of O'Fallon
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Ottawa
Illinois CancerCare-Ottawa Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Pekin
Illinois CancerCare-Pekin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peoria
Illinois CancerCare-Peoria
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peru
Illinois CancerCare-Peru
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Plainfield
Edward Hospital / Cancer Center?Plainfield
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Cancerresearch@edward.org

Princeton
Illinois CancerCare-Princeton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Springfield
Southern Illinois University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Springfield Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Urbana
Carle Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Research@carle.com

The Carle Foundation Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Research@carle.com

Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

IN
Fort Wayne
Parkview Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Indianapolis
Franciscan Health Indianapolis
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Indiana University / Melvin and Bren Simon Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: iutrials@iu.edu

Sidney and Lois Eskenazi Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: iutrials@iu.edu

Michigan City
Woodland Cancer Care Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: sally.arnett@franciscanalliance.org

Mooresville
Franciscan Health Mooresville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Richmond
Reid Health
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

South Bend
Memorial Hospital of South Bend
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

KS
Hays
HaysMed University of Kansas Health System
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Kansas City
University of Kansas Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Lawrence
Lawrence Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Stephanie.Norris@LMH.ORG

Olathe
Olathe Health Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Jeni.wakefield@olathehealth.org

Overland Park
University of Kansas Cancer Center-Overland Park
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Pittsburg
Ascension Via Christi - Pittsburg
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: jennifer.jameson@ascension.org

Salina
Salina Regional Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mleepers@srhc.com

Topeka
Cotton O'Neil Cancer Center / Stormont Vail Health
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

University of Kansas Health System Saint Francis Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

KY
Lexington
University of Kentucky / Markey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

LA
Baton Rouge
LSU Health Baton Rouge-North Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicalresearch@marybird.com

Louisiana Hematology Oncology Associates LLC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicalresearch@marybird.com

Mary Bird Perkins Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicalresearch@marybird.com

Our Lady of the Lake Physicians Group - Medical Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicalresearch@marybird.com

Covington
Northshore Oncology Associates-Covington
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicalresearch@marybird.com

Houma
Oncology Center of The South Incorporated
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicalresearch@marybird.com

Metairie
East Jefferson General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: emede1@lsuhsc.edu

LSU Healthcare Network / Metairie Multi-Specialty Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: emede1@lsuhsc.edu

New Orleans
Louisiana State University Health Science Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: emede1@lsuhsc.edu

Ochsner Medical Center Jefferson
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Gregory.Johnstone@ochsner.org

Tulane University Health Sciences Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

University Medical Center New Orleans
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: emede1@lsuhsc.edu

Shreveport
LSU Health Sciences Center at Shreveport
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: LPost@lsuhsc.edu

MA
Beverly
Beverly Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Boston
Beth Israel Deaconess Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Boston Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Brigham and Women's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Massachusetts General Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Burlington
Lahey Hospital and Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerclinicaltrials@lahey.org

Fitchburg
Simonds-Sinon Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Winchester
Winchester Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ctsucontact@westat.com

Worcester
UMass Memorial Medical Center - University Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancer.research@umassmed.edu

MD
Baltimore
Greater Baltimore Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Johns Hopkins University / Sidney Kimmel Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: jhcccro@jhmi.edu

ME
Augusta
Harold Alfond Center for Cancer Care
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Bangor
Eastern Maine Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Belfast
Waldo County General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Biddeford
MaineHealth / SMHC Cancer Care and Blood Disorders-Biddeford
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: LLemire@mmc.org

Brewer
Lafayette Family Cancer Center-EMMC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Rockport
Penobscot Bay Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ClinicalResearch@mmc.org

Sanford
MaineHealth / SMHC Cancer Care and Blood Disorders-Sanford
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: LLemire@mmc.org

South Portland
Maine Medical Partners - South Portland
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ClinicalResearch@mmc.org

MI
Ann Arbor
Saint Joseph Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

University of Michigan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Brighton
Saint Joseph Mercy Brighton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Canton
Saint Joseph Mercy Canton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Chelsea
Saint Joseph Mercy Chelsea
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Detroit
Henry Ford Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CTOResearch@hfhs.org

Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Farmington Hills
Weisberg Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Grand Rapids
Spectrum Health at Butterworth Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Lansing
Sparrow Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Novi
Ascension Providence Hospitals - Novi
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: karen.fife@ascension.org

Royal Oak
William Beaumont Hospital-Royal Oak
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Southfield
Ascension Providence Hospitals - Southfield
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: karen.fife@ascension.org

Troy
William Beaumont Hospital - Troy
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

MN
Minneapolis
Abbott-Northwestern Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minneapolis VA Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Rochester
Mayo Clinic in Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Saint Cloud
Coborn Cancer Center at Saint Cloud Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: coborncancercenter@centracare.com

MO
Cape Girardeau
Saint Francis Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: sfmc@sfmc.net

Chesterfield
Saint Luke's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Columbia
University of Missouri - Ellis Fischel
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Creve Coeur
Siteman Cancer Center at West County Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Kansas City
Truman Medical Centers
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

University of Kansas Cancer Center - North
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Lee's Summit
University of Kansas Cancer Center - Lee's Summit
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Saint Louis
Mercy Hospital Saint Louis
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Missouri Baptist Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Washington University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: info@siteman.wustl.edu

MS
Gulfport
Gulfport Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: emede1@lsuhsc.edu

Jackson
University of Mississippi Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

MT
Bozeman
Bozeman Deaconess Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

NC
Cary
Rex Hematology Oncology Associates-Cary
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerclinicaltrials@med.unc.edu

Clinton
Southeastern Medical Oncology Center-Clinton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: jfields@cancersmoc.com

Durham
Duke University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: jfields@cancersmoc.com

Wayne Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ecooke@cancersmoc.com

Jacksonville
Onslow Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ecooke@cancersmoc.com

Southeastern Medical Oncology Center-Jacksonville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: jfields@cancersmoc.com

Kenansville
Vidant Oncology-Kenansville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Carla.Zimmerman@vidanthealth.com

Kinston
Vidant Oncology-Kinston
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Carla.Zimmerman@vidanthealth.com

Raleigh
Rex Cancer Center of Wakefield
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Rex Hematology Oncology Associates-Blue Ridge
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

UNC Rex Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Richlands
Vidant Oncology-Richlands
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Carla.Zimmerman@vidanthealth.com

Winston-Salem
Novant Health Forsyth Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: asmarrs@novanthealth.org

Wake Forest University Health Sciences
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

ND
Bismarck
Sanford Bismarck Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Fargo
Sanford Broadway Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Roger Maris Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

NE
Grand Island
CHI Health Saint Francis
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

Omaha
Nebraska Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

NH
Lebanon
Dartmouth Hitchcock Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancer.research.nurse@dartmouth.edu

NJ
Englewood
Englewood Hospital and Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Hackensack
Hackensack University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Somerville
Robert Wood Johnson University Hospital Somerset
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Siby.Varughese@rwjbh.org

NV
Henderson
OptumCare Cancer Care at Seven Hills
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Town Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Charleston
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Fort Apache
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

University Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

Reno
Renown Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

NY
Albany
Albany Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Bronx
James J Peters VA Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: kl2965@cumc.columbia.edu

Montefiore Medical Center - Moses Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: eskwak@montefiore.org

Montefiore Medical Center-Einstein Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: eskwak@montefiore.org

Montefiore Medical Center-Weiler Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: eskwak@montefiore.org

Glens Falls
Glens Falls Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Lake Success
Northwell Health / Center for Advanced Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

New Hyde Park
Long Island Jewish Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CancerTrials@nyulangone.org

NYP / Weill Cornell Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Rochester
University of Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Syracuse
State University of New York Upstate Medical University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

White Plains
Dickstein Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mcortese@wphospital.org

OH
Akron
Summa Health System - Akron Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerresearch@summahealth.org

Beachwood
UHHS-Chagrin Highlands Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

Centerville
Dayton Physicians LLC-Miami Valley South
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Cincinnati
Bethesda North Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

Good Samaritan Hospital - Cincinnati
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

University of Cincinnati Cancer Center-UC Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: uchealthnews@uc.edu

Cleveland
Case Western Reserve University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

MetroHealth Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: dstrater@metrohealth.org

Franklin
Dayton Physicians LLC-Atrium
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Kettering
Kettering Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Middleburg Heights
UH Seidman Cancer Center at Southwest General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

Toledo
Toledo Clinic Cancer Centers-Toledo
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

West Chester
University of Cincinnati Cancer Center-West Chester
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinicaltrials@ucphysicians.com

Westlake
UH Seidman Cancer Center at Saint John Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

OK
Oklahoma City
Mercy Hospital Oklahoma City
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

University of Oklahoma Health Sciences Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu

OR
Clackamas
Providence Cancer Institute Clackamas Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Medford
Rogue Valley Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Newberg
Providence Newberg Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Oregon City
Providence Willamette Falls Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Portland
Kaiser Permanente Northwest
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: information@kpchr.org

Oregon Health and Science University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: trials@ohsu.edu

Providence Portland Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

PA
Allentown
Lehigh Valley Hospital-Cedar Crest
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Bethlehem
Lehigh Valley Hospital - Muhlenberg
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Danville
Geisinger Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Hershey
Penn State Milton S Hershey Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CTO@hmc.psu.edu

Philadelphia
Fox Chase Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Temple University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

University of Pennsylvania / Abramson Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

West Reading
Reading Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Williamsport
UPMC Susquehanna
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

RI
Providence
Miriam Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Rhode Island Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

SC
Boiling Springs
Prisma Health Cancer Institute - Spartanburg
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: kim.williams3@prismahealth.org

Charleston
Medical University of South Carolina
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: hcc-clinical-trials@musc.edu

Ralph H Johnson VA Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ashley.salvo@va.gov

Clinton
Prisma Health Cancer Institute - Laurens
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: kim.williams3@prismahealth.org

Easley
Prisma Health Cancer Institute - Easley
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: kim.williams3@prismahealth.org

Gaffney
Gibbs Cancer Center-Gaffney
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: kmertz-rivera@gibbscc.org

Greenville
Prisma Health Cancer Institute - Butternut
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: kim.williams3@prismahealth.org

Prisma Health Cancer Institute - Eastside
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: kim.williams3@prismahealth.org

Prisma Health Cancer Institute - Faris
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: kim.williams3@prismahealth.org

Saint Francis Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: melissa_beckman@bshsi.org

Saint Francis Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: melissa_beckman@bshsi.org

Greer
Gibbs Cancer Center-Pelham
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: kmertz-rivera@gibbscc.org

Prisma Health Cancer Institute - Greer
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: kim.williams3@prismahealth.org

Seneca
Prisma Health Cancer Institute - Seneca
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: kim.williams3@prismahealth.org

Spartanburg
Spartanburg Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: kmertz-rivera@gibbscc.org

West Columbia
Lexington Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: LMCIRB@lexhealth.org

TN
Nashville
Meharry Medical College
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Nancy.McCullough@NashvilleHA.org

Vanderbilt University / Ingram Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

TX
Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

Fort Worth
UT Southwestern / Simmons Cancer Center-Fort Worth
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

Galveston
University of Texas Medical Branch
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.research@utmb.edu

Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: burton@bcm.edu

Ben Taub General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

League City
UTMB Cancer Center at Victory Lakes
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Richardson
UT Southwestern Clinical Center at Richardson / Plano
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Suzanne.cole@utsouthwestern.edu

San Antonio
Audie L Murphy VA Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

University of Texas Health Science Center at San Antonio
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: phoresearchoffice@uthscsa.edu

UT
Farmington
Farmington Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu

South Jordan
South Jordan Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu

VA
Charlottesville
University of Virginia Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: uvacancertrials@hscmail.mcc.virginia.edu

Martinsville
Sovah Health Martinsville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: sharon.hubbard@lpnt.net

Mechanicsville
Bon Secours Memorial Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Jaime_scott@bshsi.org

Midlothian
Bon Secours Saint Francis Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Jaime_scott@bshsi.org

Richmond
Bon Secours Saint Mary's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Jaime_scott@bshsi.org

Virginia Commonwealth University / Massey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: klcampbell@vcu.edu

VT
Berlin
Central Vermont Medical Center / National Life Cancer Treatment
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Burlington
University of Vermont Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: rpo@uvm.edu

University of Vermont and State Agricultural College
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: rpo@uvm.edu

WI
Antigo
Langlade Hospital and Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Juli.Alford@aspirus.org

Appleton
ThedaCare Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchDept@thedacare.org

Brookfield
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org

Burlington
Aurora Cancer Care-Southern Lakes VLCC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Eau Claire
Marshfield Medical Center-EC Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Fond Du Lac
Aurora Health Center-Fond du Lac
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Franklin
Ascension Saint Francis - Reiman Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org

Germantown
Aurora Health Care Germantown Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Grafton
Aurora Cancer Care-Grafton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Green Bay
Aurora BayCare Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Johnson Creek
UW Cancer Center Johnson Creek
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: lynda.persico@uwmf.wisc.edu

Kenosha
Aurora Cancer Care-Kenosha South
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Madison
University of Wisconsin Carbone Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

William S Middleton VA Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Marinette
Aurora Bay Area Medical Group-Marinette
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Marshfield
Marshfield Medical Center-Marshfield
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Medford
Aspirus Medford Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Beth.Knetter@aspirus.org

Milwaukee
Aurora Cancer Care-Milwaukee
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Aurora Saint Luke's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Aurora Sinai Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Medical College of Wisconsin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Minocqua
Marshfield Clinic-Minocqua Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Mukwonago
ProHealth D N Greenwald Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research.institute@phci.org

Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Racine
Aurora Cancer Care-Racine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Rice Lake
Marshfield Medical Center-Rice Lake
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Summit
Aurora Medical Center in Summit
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Waukesha
ProHealth Waukesha Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

UW Cancer Center at ProHealth Care
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Chanda.miller@phci.org

Wausau
Aspirus Regional Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Marshfield Clinic-Wausau Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wauwatosa
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org

Aurora Cancer Care-Milwaukee West
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

West Allis
Aurora West Allis Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ncorp@aurora.org

Weston
Marshfield Medical Center - Weston
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wisconsin Rapids
Aspirus Cancer Care - Wisconsin Rapids
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

PRIMARY OBJECTIVE:
I. To compare recurrence-free survival (RFS) between patients with renal cell carcinoma randomly assigned to perioperative nivolumab in conjunction with radical or partial nephrectomy with patients randomized to surgery alone.

SECONDARY OBJECTIVES:
I. To evaluate for differences in recurrence-free survival associated with perioperative nivolumab compared to surgery alone among the subset of patients with clear cell histology.
II. To compare the overall survival between the two arms.
III. To describe the safety and tolerability of perioperative nivolumab.

CORRELATIVE OBJECTIVES:
I. To correlate the primary tumor’s expression of PD-L1 with outcome.
II. To correlate the expression of PD-L1 on tumor tissue at nephrectomy and recurrence with outcome.
III. To archive images for potential central confirmation of recurrence and for future correlative work with American College of Radiology Imaging Network (ACRIN), including markers predicting outcome or response.
IV. To prospectively collect tumor and biologic specimens (e.g., serum, peripheral blood mononuclear cells [PBMCs]) for future correlative studies.
V. To characterize the pharmacokinetics of nivolumab and explore exposure response relationships with respect to safety and efficacy.
VI. To characterize the immunogenicity of nivolumab.

QUALITY OF LIFE OBJECTIVE:
I. To evaluate differences in change from baseline in patient-reported symptoms and toxicities among patients randomized to treatment with nivolumab compared to surgery alone.

OTHER EXPLORATORY OBJECTIVES:
I. To explore descriptively the efficacy of treatment with nivolumab in patients with non-clear cell (including unclassified) histologies.
II. To characterize the effects of nivolumab on bone metabolism and bone density.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive nivolumab intravenously (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. Patient 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. Patients 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.

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

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and every 12 months for 5 years.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed and conducted this trial with funding from the National Cancer Institute through its National Clinical Trials Network.


EA8143 / PROSPER RCC (Closed)
ECOG-ACRIN Cancer Research Group