Kidney Cancer
EA8143 / PROSPER RCC
Nivolumab in Treating Patients with Localized Kidney Cancer Undergoing Nephrectomy
STATUS: Closed to Accrual and Intervention
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
Contact: Site Public Contact
Edmonton
Cross Cancer Institute
Contact: Site Public Contact
Manitoba
Winnipeg
CancerCare Manitoba
Contact: Site Public Contact
Email: ctu_web@cancercare.mb.ca
New Brunswick
Moncton
The Moncton Hospital
Contact: Site Public Contact
Nova Scotia
Halifax
QEII Health Sciences Centre/Nova Scotia Health Authority
Contact: Site Public Contact
Ontario
Hamilton
Juravinski Cancer Centre at Hamilton Health Sciences
Contact: Site Public Contact
Saint Joseph's Healthcare Charlton Campus
Contact: Site Public Contact
Email: research@stjoes.ca
Kingston
Kingston Health Sciences Centre
Contact: Site Public Contact
Email: cc-clinicaltrials@kgh.kari.net
London
London Regional Cancer Program
Contact: Site Public Contact
Saint Catharines
Niagara Health System-Saint Catharines General
Contact: Site Public Contact
Toronto
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Contact: Site Public Contact
University Health Network-Princess Margaret Hospital
Contact: Site Public Contact
Email: clinical.trials@uhn.on.ca
Windsor
Windsor Regional Cancer Centre
Contact: Site Public Contact
Quebec
Montreal
CHUM - Centre Hospitalier de l'Universite de Montreal
Contact: Site Public Contact
Email: info.cr.chum@ssss.gouv.qc.ca
Sherbrooke
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Contact: Site Public Contact
Email: crcinformation.chus@ssss.gouv.qc.ca
Israel
Haifa
Rambam Medical Center
Contact: Site Public Contact
Email: y_rozen@rambam.health.gov.il
Jerusalem
Shaare Zedek Medical Center
Contact: Site Public Contact
United States
AL
Birmingham
University of Alabama at Birmingham Cancer Center
Contact: Site Public Contact
Email: tmyrick@uab.edu
Veterans Administration Medical Center - Birmingham
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
AZ
Gilbert
Banner MD Anderson Cancer Center
Contact: Site Public Contact
Phoenix
Cancer Center at Saint Joseph's
Contact: Site Public Contact
Tucson
Banner University Medical Center - Tucson
Contact: Site Public Contact
Email: aselegue@email.arizona.edu
University of Arizona Cancer Center-North Campus
Contact: Site Public Contact
CA
Anaheim
Kaiser Permanente-Anaheim
Contact: Site Public Contact
Email: clinical.trials@kp.org
Auburn
Sutter Auburn Faith Hospital
Contact: Site Public Contact
Email: bernicl@sutterhealth.org
Bakersfield
AIS Cancer Center at San Joaquin Community Hospital
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Baldwin Park
Kaiser Permanente-Baldwin Park
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Email: clinical.trials@kp.org
Bellflower
Kaiser Permanente-Bellflower
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Email: clinical.trials@kp.org
Berkeley
Alta Bates Summit Medical Center-Herrick Campus
Contact: Site Public Contact
Email: bernicl@sutterhealth.org
Burlingame
Mills-Peninsula Medical Center
Contact: Site Public Contact
Email: bernicl@sutterhealth.org
Clovis
Community Cancer Institute
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Duarte
City of Hope Comprehensive Cancer Center
Contact: Site Public Contact
Email: becomingapatient@coh.org
Fontana
Kaiser Permanente-Fontana
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Email: clinical.trials@kp.org
Harbor City
Kaiser Permanente - Harbor City
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Email: clinical.trials@kp.org
Irvine
Kaiser Permanente-Irvine
Contact: Site Public Contact
Email: clinical.trials@kp.org
La Jolla
UC San Diego Moores Cancer Center
Contact: Site Public Contact
Email: cancercto@ucsd.edu
Los Angeles
Cedars Sinai Medical Center
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Kaiser Permanente Los Angeles Medical Center
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Email: clinical.trials@kp.org
Kaiser Permanente West Los Angeles
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Email: clinical.trials@kp.org
UCLA / Jonsson Comprehensive Cancer Center
Contact: Site Public Contact
USC / Norris Comprehensive Cancer Center
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Marysville
Fremont - Rideout Cancer Center
Contact: Site Public Contact
Mountain View
Palo Alto Medical Foundation-Camino Division
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Email: bernicl@sutterhealth.org
Newport Beach
USC Norris Oncology/Hematology-Newport Beach
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Oakland
Kaiser Permanente-Oakland
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Email: Kpoct@kp.org
Ontario
Kaiser Permanente-Ontario
Contact: Site Public Contact
Email: clinical.trials@kp.org
Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
Contact: Site Public Contact
Email: ucstudy@uci.edu
Palo Alto
Palo Alto Medical Foundation Health Care
Contact: Site Public Contact
Email: bernicl@sutterhealth.org
Stanford Cancer Institute Palo Alto
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Email: ccto-office@stanford.edu
VA Palo Alto Health Care System
Contact: Site Public Contact
Panorama City
Kaiser Permanente - Panorama City
Contact: Site Public Contact
Email: clinical.trials@kp.org
Rancho Mirage
Eisenhower Medical Center
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Riverside
Kaiser Permanente-Riverside
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Email: clinical.trials@kp.org
Roseville
Kaiser Permanente-Roseville
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Email: Kpoct@kp.org
Sutter Roseville Medical Center
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Email: bernicl@sutterhealth.org
Sacramento
Kaiser Permanente - Sacramento
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Email: Kpoct@kp.org
Kaiser Permanente Downtown Commons
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Email: kpoct@kp.org
Sutter Medical Center Sacramento
Contact: Site Public Contact
Email: bernicl@sutterhealth.org
University of California Davis Comprehensive Cancer Center
Contact: Site Public Contact
San Diego
Kaiser Permanente-San Diego Zion
Contact: Site Public Contact
Email: clinical.trials@kp.org
San Francisco
California Pacific Medical Center-Pacific Campus
Contact: Site Public Contact
Email: bernicl@sutterhealth.org
Kaiser Permanente-San Francisco
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Email: Kpoct@kp.org
San Jose
Kaiser Permanente-Santa Teresa-San Jose
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Email: Kpoct@kp.org
San Leandro
Kaiser Permanente San Leandro
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Email: Kpoct@kp.org
San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
Contact: Site Public Contact
Email: Diane.DeVos-Schmidt@DignityHealth.org
San Marcos
Kaiser Permanente-San Marcos
Contact: Site Public Contact
Email: clinical.trials@kp.org
Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Contact: Site Public Contact
Email: Kpoct@kp.org
Santa Cruz
Palo Alto Medical Foundation-Santa Cruz
Contact: Site Public Contact
Email: bernicl@sutterhealth.org
South San Francisco
Kaiser Permanente-South San Francisco
Contact: Site Public Contact
Email: Kpoct@kp.org
Sunnyvale
Palo Alto Medical Foundation-Sunnyvale
Contact: Site Public Contact
Email: bernicl@sutterhealth.org
Truckee
Gene Upshaw Memorial Tahoe Forest Cancer Center
Contact: Site Public Contact
Vallejo
Kaiser Permanente-Vallejo
Contact: Site Public Contact
Email: Kpoct@kp.org
Sutter Solano Medical Center/Cancer Center
Contact: Site Public Contact
Email: bernicl@sutterhealth.org
Walnut Creek
Kaiser Permanente-Walnut Creek
Contact: Site Public Contact
Email: Kpoct@kp.org
Whittier
Presbyterian Intercommunity Hospital
Contact: Site Public Contact
Woodland Hills
Kaiser Permanente-Woodland Hills
Contact: Site Public Contact
Email: clinical.trials@kp.org
CO
Aurora
UCHealth University of Colorado Hospital
Contact: Site Public Contact
Colorado Springs
Memorial Hospital North
Contact: Site Public Contact
UCHealth Memorial Hospital Central
Contact: Site Public Contact
Fort Collins
Cancer Care and Hematology-Fort Collins
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Poudre Valley Hospital
Contact: Site Public Contact
Greeley
UCHealth Greeley Hospital
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Loveland
Medical Center of the Rockies
Contact: Site Public Contact
CT
Hartford
Hartford Hospital
Contact: Site Public Contact
Meriden
Midstate Medical Center
Contact: Site Public Contact
New Britain
The Hospital of Central Connecticut
Contact: Site Public Contact
New Haven
Yale University
Contact: Site Public Contact
Email: canceranswers@yale.edu
Norwich
Eastern Connecticut Hematology and Oncology Associates
Contact: Site Public Contact
DC
Washington
George Washington University Medical Center
Contact: Site Public Contact
MedStar Washington Hospital Center
Contact: Site Public Contact
Sibley Memorial Hospital
Contact: Site Public Contact
Email: jquiver1@jhmi.edu
FL
Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Contact: Site Public Contact
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Contact: Site Public Contact
Fort Lauderdale
Holy Cross Hospital
Contact: Site Public Contact
Gainesville
University of Florida Health Science Center - Gainesville
Contact: Site Public Contact
Email: cancer-center@ufl.edu
Jacksonville
Baptist MD Anderson Cancer Center
Contact: Site Public Contact
Lakeland
Lakeland Regional Health Hollis Cancer Center
Contact: Site Public Contact
The Watson Clinic
Contact: Site Public Contact
Miami
Miami Cancer Institute
Contact: Site Public Contact
UM Sylvester Comprehensive Cancer Center at Kendall
Contact: Site Public Contact
University of Miami Miller School of Medicine-Sylvester Cancer Center
Contact: Site Public Contact
Plantation
UM Sylvester Comprehensive Cancer Center at Plantation
Contact: Site Public Contact
GA
Atlanta
Emory University Hospital/Winship Cancer Institute
Contact: Site Public Contact
Decatur
Atlanta VA Medical Center
Contact: Site Public Contact
HI
Aiea
Hawaii Cancer Care - Westridge
Contact: Site Public Contact
Pali Momi Medical Center
Contact: Site Public Contact
Honolulu
Hawaii Cancer Care Inc - Waterfront Plaza
Contact: Site Public Contact
Email: i.webster@hawaiicancercare.com
Queen's Cancer Cenrer - POB I
Contact: Site Public Contact
Queen's Cancer Center - Kuakini
Contact: Site Public Contact
Queen's Medical Center
Contact: Site Public Contact
Straub Clinic and Hospital
Contact: Site Public Contact
IA
Ames
Mary Greeley Medical Center
Contact: Site Public Contact
McFarland Clinic - Ames
Contact: Site Public Contact
Email: ksoder@mcfarlandclinic.com
Boone
McFarland Clinic - Boone
Contact: Site Public Contact
Clive
Mercy Cancer Center-West Lakes
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org
Mission Cancer and Blood - West Des Moines
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org
Des Moines
Mercy Medical Center - Des Moines
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org
Mission Cancer and Blood - Laurel
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org
Fort Dodge
McFarland Clinic - Trinity Cancer Center
Contact: Site Public Contact
Jefferson
McFarland Clinic - Jefferson
Contact: Site Public Contact
Marshalltown
McFarland Clinic - Marshalltown
Contact: Site Public Contact
West Des Moines
Mercy Medical Center-West Lakes
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org
ID
Boise
Saint Luke's Cancer Institute - Boise
Contact: Site Public Contact
Email: eslinget@slhs.org
Coeur D'Alene
Kootenai Health - Coeur d'Alene
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Fruitland
Saint Luke's Cancer Institute - Fruitland
Contact: Site Public Contact
Email: eslinget@slhs.org
Meridian
Saint Luke's Cancer Institute - Meridian
Contact: Site Public Contact
Email: eslinget@slhs.org
Nampa
Saint Luke's Cancer Institute - Nampa
Contact: Site Public Contact
Email: eslinget@slhs.org
Post Falls
Kootenai Clinic Cancer Services - Post Falls
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Sandpoint
Kootenai Clinic Cancer Services - Sandpoint
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Contact: Site Public Contact
Email: eslinget@slhs.org
IL
Bloomington
Illinois CancerCare-Bloomington
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Canton
Illinois CancerCare-Canton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Carthage
Illinois CancerCare-Carthage
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Chicago
Northwestern University
Contact: Site Public Contact
Email: cancer@northwestern.edu
Rush University Medical Center
Contact: Site Public Contact
Email: clinical_trials@rush.edu
University of Chicago Comprehensive Cancer Center
Contact: Site Public Contact
Email: cancerclinicaltrials@bsd.uchicago.edu
University of Illinois
Contact: Site Public Contact
Danville
Carle at The Riverfront
Contact: Site Public Contact
Email: Research@carle.com
Decatur
Cancer Care Specialists of Illinois - Decatur
Contact: Site Public Contact
Email: rhamrick@dmhhs.org
Effingham
Carle Physician Group-Effingham
Contact: Site Public Contact
Email: Research@carle.com
Crossroads Cancer Center
Contact: Site Public Contact
Email: rhamrick@dmhhs.org
Elmhurst
Elmhurst Memorial Hospital
Contact: Site Public Contact
Email: Jrohde@emhc.org
Eureka
Illinois CancerCare-Eureka
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Galesburg
Illinois CancerCare-Galesburg
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Geneva
Northwestern Medicine Cancer Center Delnor
Contact: Site Public Contact
Email: Donald.Smith3@nm.org
Hines
Edward Hines Jr VA Hospital
Contact: Site Public Contact
Kewanee
Illinois CancerCare-Kewanee Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Macomb
Illinois CancerCare-Macomb
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Mattoon
Carle Physician Group-Mattoon/Charleston
Contact: Site Public Contact
Email: Research@carle.com
Maywood
Loyola University Medical Center
Contact: Site Public Contact
Naperville
Edward Hospital/Cancer Center
Contact: Site Public Contact
O'Fallon
Cancer Care Center of O'Fallon
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Ottawa
Illinois CancerCare-Ottawa Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Pekin
Illinois CancerCare-Pekin
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Peoria
Illinois CancerCare-Peoria
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Peru
Illinois CancerCare-Peru
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Plainfield
Edward Hospital/Cancer Center?Plainfield
Contact: Site Public Contact
Email: Cancerresearch@edward.org
Princeton
Illinois CancerCare-Princeton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Springfield
Southern Illinois University School of Medicine
Contact: Site Public Contact
Springfield Clinic
Contact: Site Public Contact
Urbana
Carle Cancer Center
Contact: Site Public Contact
Email: Research@carle.com
The Carle Foundation Hospital
Contact: Site Public Contact
Email: Research@carle.com
Warrenville
Northwestern Medicine Cancer Center Warrenville
Contact: Site Public Contact
Email: Donald.Smith3@nm.org
IN
Fort Wayne
Parkview Regional Medical Center
Contact: Site Public Contact
Indianapolis
Franciscan Health Indianapolis
Contact: Site Public Contact
Indiana University/Melvin and Bren Simon Cancer Center
Contact: Site Public Contact
Email: iutrials@iu.edu
Sidney and Lois Eskenazi Hospital
Contact: Site Public Contact
Email: iutrials@iu.edu
Michigan City
Woodland Cancer Care Center
Contact: Site Public Contact
Email: sally.arnett@franciscanalliance.org
Mooresville
Franciscan Health Mooresville
Contact: Site Public Contact
Richmond
Reid Health
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
South Bend
Memorial Hospital of South Bend
Contact: Site Public Contact
KS
Hays
HaysMed
Contact: Site Public Contact
Kansas City
University of Kansas Cancer Center
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu
Lawrence
Lawrence Memorial Hospital
Contact: Site Public Contact
Email: Stephanie.Norris@LMH.ORG
Olathe
Olathe Health Cancer Center
Contact: Site Public Contact
Email: Jeni.wakefield@olathehealth.org
Overland Park
University of Kansas Cancer Center-Overland Park
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu
Pittsburg
Ascension Via Christi - Pittsburg
Contact: Site Public Contact
Email: jennifer.jameson@ascension.org
Salina
Salina Regional Health Center
Contact: Site Public Contact
Email: mleepers@srhc.com
Topeka
Cotton O'Neil Cancer Center / Stormont Vail Health
Contact: Site Public Contact
University of Kansas Health System Saint Francis Campus
Contact: Site Public Contact
Westwood
University of Kansas Hospital-Westwood Cancer Center
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu
KY
Lexington
University of Kentucky/Markey Cancer Center
Contact: Site Public Contact
LA
Baton Rouge
LSU Health Baton Rouge-North Clinic
Contact: Site Public Contact
Email: clinicalresearch@marybird.com
Louisiana Hematology Oncology Associates LLC
Contact: Site Public Contact
Email: clinicalresearch@marybird.com
Mary Bird Perkins Cancer Center
Contact: Site Public Contact
Email: clinicalresearch@marybird.com
Our Lady of the Lake Physician Group
Contact: Site Public Contact
Email: clinicalresearch@marybird.com
Covington
Northshore Oncology Associates-Covington
Contact: Site Public Contact
Email: clinicalresearch@marybird.com
Houma
Oncology Center of The South Incorporated
Contact: Site Public Contact
Email: clinicalresearch@marybird.com
Metairie
East Jefferson General Hospital
Contact: Site Public Contact
Email: emede1@lsuhsc.edu
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Contact: Site Public Contact
Email: emede1@lsuhsc.edu
New Orleans
Louisiana State University Health Science Center
Contact: Site Public Contact
Email: emede1@lsuhsc.edu
Ochsner Medical Center Jefferson
Contact: Site Public Contact
Email: Gregory.Johnstone@ochsner.org
Tulane University School of Medicine
Contact: Site Public Contact
University Medical Center New Orleans
Contact: Site Public Contact
Email: emede1@lsuhsc.edu
Shreveport
LSU Health Sciences Center at Shreveport
Contact: Site Public Contact
Email: LPost@lsuhsc.edu
MA
Beverly
Beverly Hospital
Contact: Site Public Contact
Boston
Beth Israel Deaconess Medical Center
Contact: Site Public Contact
Boston Medical Center
Contact: Site Public Contact
Brigham and Women's Hospital
Contact: Site Public Contact
Dana-Farber Cancer Institute
Contact: Site Public Contact
Massachusetts General Hospital Cancer Center
Contact: Site Public Contact
Burlington
Lahey Hospital and Medical Center
Contact: Site Public Contact
Email: cancerclinicaltrials@lahey.org
Fitchburg
Simonds-Sinon Regional Cancer Center
Contact: Site Public Contact
Winchester
Winchester Hospital
Contact: Site Public Contact
Email: ctsucontact@westat.com
Worcester
UMass Memorial Medical Center - University Campus
Contact: Site Public Contact
Email: cancer.research@umassmed.edu
MD
Baltimore
Greater Baltimore Medical Center
Contact: Site Public Contact
Johns Hopkins University/Sidney Kimmel Cancer Center
Contact: Site Public Contact
Email: jhcccro@jhmi.edu
ME
Augusta
Harold Alfond Center for Cancer Care
Contact: Site Public Contact
Bangor
Eastern Maine Medical Center
Contact: Site Public Contact
Belfast
Waldo County General Hospital
Contact: Site Public Contact
Biddeford
MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
Contact: Site Public Contact
Email: LLemire@mmc.org
Brewer
Lafayette Family Cancer Center-EMMC
Contact: Site Public Contact
Rockport
Penobscot Bay Medical Center
Contact: Site Public Contact
Email: ClinicalResearch@mmc.org
Sanford
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Contact: Site Public Contact
Email: LLemire@mmc.org
South Portland
Maine Medical Partners - South Portland
Contact: Site Public Contact
Email: ClinicalResearch@mmc.org
MI
Ann Arbor
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org
University of Michigan Comprehensive Cancer Center
Contact: Site Public Contact
Brighton
Trinity Health Medical Center - Brighton
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org
Canton
Trinity Health Medical Center - Canton
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org
Chelsea
Chelsea Hospital
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org
Detroit
Henry Ford Hospital
Contact: Site Public Contact
Email: CTOResearch@hfhs.org
Wayne State University/Karmanos Cancer Institute
Contact: Site Public Contact
Email: ctoadmin@karmanos.org
Farmington Hills
Weisberg Cancer Treatment Center
Contact: Site Public Contact
Email: ctoadmin@karmanos.org
Grand Rapids
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org
Lansing
University of Michigan Health - Sparrow Lansing
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org
Novi
Henry Ford Health Providence Novi Hospital
Contact: Site Public Contact
Email: karen.fife@ascension.org
Royal Oak
Corewell Health William Beaumont University Hospital
Contact: Site Public Contact
Southfield
Henry Ford Health Providence Southfield Hospital
Contact: Site Public Contact
Email: karen.fife@ascension.org
Troy
Corewell Health Beaumont Troy Hospital
Contact: Site Public Contact
MN
Minneapolis
Abbott-Northwestern Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Minneapolis VA Medical Center
Contact: Site Public Contact
Rochester
Mayo Clinic in Rochester
Contact: Site Public Contact
Saint Cloud
Coborn Cancer Center at Saint Cloud Hospital
Contact: Site Public Contact
Email: coborncancercenter@centracare.com
MO
Cape Girardeau
Saint Francis Medical Center
Contact: Site Public Contact
Email: sfmc@sfmc.net
Chesterfield
Saint Luke's Hospital
Contact: Site Public Contact
Columbia
MU Health - University Hospital/Ellis Fischel Cancer Center
Contact: Site Public Contact
Creve Coeur
Siteman Cancer Center at West County Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Kansas City
University Health Truman Medical Center
Contact: Site Public Contact
University of Kansas Cancer Center - North
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu
Lee's Summit
University of Kansas Cancer Center - Lee's Summit
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu
Saint Louis
Mercy Hospital Saint Louis
Contact: Site Public Contact
Missouri Baptist Medical Center
Contact: Site Public Contact
Washington University School of Medicine
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu
MS
Gulfport
Gulfport Memorial Hospital
Contact: Site Public Contact
Email: emede1@lsuhsc.edu
Jackson
University of Mississippi Medical Center
Contact: Site Public Contact
MT
Bozeman
Bozeman Health Deaconess Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Great Falls
Benefis Sletten Cancer Institute
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
NC
Cary
Rex Hematology Oncology Associates-Cary
Contact: Site Public Contact
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Contact: Site Public Contact
Email: cancerclinicaltrials@med.unc.edu
Clinton
Southeastern Medical Oncology Center-Clinton
Contact: Site Public Contact
Email: jfields@cancersmoc.com
Durham
Duke University Medical Center
Contact: Site Public Contact
Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Contact: Site Public Contact
Email: jfields@cancersmoc.com
Wayne Memorial Hospital
Contact: Site Public Contact
Email: ecooke@cancersmoc.com
Jacksonville
Onslow Memorial Hospital
Contact: Site Public Contact
Email: ecooke@cancersmoc.com
Southeastern Medical Oncology Center-Jacksonville
Contact: Site Public Contact
Email: jfields@cancersmoc.com
Kenansville
ECU Health Oncology Kenansville
Contact: Site Public Contact
Email: Carla.Zimmerman@vidanthealth.com
Kinston
ECU Health Oncology Kinston
Contact: Site Public Contact
Email: Carla.Zimmerman@vidanthealth.com
Raleigh
Rex Hematology Oncology Associates-Blue Ridge
Contact: Site Public Contact
UNC Rex Cancer Center of Wakefield
Contact: Site Public Contact
UNC Rex Healthcare
Contact: Site Public Contact
Richlands
ECU Health Oncology Richlands
Contact: Site Public Contact
Email: Carla.Zimmerman@vidanthealth.com
Winston-Salem
Novant Health Forsyth Medical Center
Contact: Site Public Contact
Email: asmarrs@novanthealth.org
Wake Forest University Health Sciences
Contact: Site Public Contact
ND
Bismarck
Sanford Bismarck Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Fargo
Sanford Broadway Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Sanford Roger Maris Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
NE
Grand Island
Nebraska Cancer Specialists/Oncology Hematology West PC
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org
Omaha
Nebraska Methodist Hospital
Contact: Site Public Contact
NH
Lebanon
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Contact: Site Public Contact
Email: cancer.research.nurse@dartmouth.edu
NJ
Englewood
Englewood Hospital and Medical Center
Contact: Site Public Contact
Hackensack
Hackensack University Medical Center
Contact: Site Public Contact
New Brunswick
Rutgers Cancer Institute of New Jersey
Contact: Site Public Contact
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Contact: Site Public Contact
Somerville
Robert Wood Johnson University Hospital Somerset
Contact: Site Public Contact
Email: Siby.Varughese@rwjbh.org
NV
Henderson
OptumCare Cancer Care at Seven Hills
Contact: Site Public Contact
Email: research@sncrf.org
Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley
Contact: Site Public Contact
Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada - Town Center
Contact: Site Public Contact
Email: research@sncrf.org
OptumCare Cancer Care at Charleston
Contact: Site Public Contact
Email: research@sncrf.org
OptumCare Cancer Care at Fort Apache
Contact: Site Public Contact
Email: research@sncrf.org
University Cancer Center
Contact: Site Public Contact
Email: research@sncrf.org
Reno
Renown Regional Medical Center
Contact: Site Public Contact
Email: research@sncrf.org
NY
Albany
Albany Medical Center
Contact: Site Public Contact
Bronx
James J Peters VA Medical Center
Contact: Site Public Contact
Email: kl2965@cumc.columbia.edu
Montefiore Medical Center - Moses Campus
Contact: Site Public Contact
Email: eskwak@montefiore.org
Montefiore Medical Center-Einstein Campus
Contact: Site Public Contact
Email: eskwak@montefiore.org
Montefiore Medical Center-Weiler Hospital
Contact: Site Public Contact
Email: eskwak@montefiore.org
Glens Falls
Glens Falls Hospital
Contact: Site Public Contact
Lake Success
Northwell Health/Center for Advanced Medicine
Contact: Site Public Contact
New Hyde Park
Long Island Jewish Medical Center
Contact: Site Public Contact
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Contact: Site Public Contact
Email: CancerTrials@nyulangone.org
NYP/Weill Cornell Medical Center
Contact: Site Public Contact
Rochester
University of Rochester
Contact: Site Public Contact
Syracuse
State University of New York Upstate Medical University
Contact: Site Public Contact
White Plains
Dickstein Cancer Treatment Center
Contact: Site Public Contact
Email: mcortese@wphospital.org
OH
Akron
Summa Health System - Akron Campus
Contact: Site Public Contact
Email: cancerresearch@summahealth.org
Beachwood
UHHS-Chagrin Highlands Medical Center
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org
Centerville
Dayton Physicians LLC-Miami Valley South
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Cincinnati
Bethesda North Hospital
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org
Good Samaritan Hospital - Cincinnati
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org
University of Cincinnati Cancer Center-UC Medical Center
Contact: Site Public Contact
Email: uchealthnews@uc.edu
Cleveland
Case Western Reserve University
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org
MetroHealth Medical Center
Contact: Site Public Contact
Email: dstrater@metrohealth.org
Franklin
Dayton Physicians LLC-Atrium
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Kettering
Kettering Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Middleburg Heights
UH Seidman Cancer Center at Southwest General Hospital
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org
Toledo
Toledo Clinic Cancer Centers-Toledo
Contact: Site Public Contact
West Chester
University of Cincinnati Cancer Center-West Chester
Contact: Site Public Contact
Email: clinicaltrials@ucphysicians.com
Westlake
UH Seidman Cancer Center at Saint John Medical Center
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org
OK
Oklahoma City
Mercy Hospital Oklahoma City
Contact: Site Public Contact
University of Oklahoma Health Sciences Center
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu
OR
Clackamas
Providence Cancer Institute Clackamas Clinic
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org
Medford
Asante Rogue Regional Medical Center
Contact: Site Public Contact
Newberg
Providence Newberg Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org
Oregon City
Providence Willamette Falls Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org
Portland
Kaiser Permanente Northwest
Contact: Site Public Contact
Email: information@kpchr.org
Oregon Health and Science University
Contact: Site Public Contact
Email: trials@ohsu.edu
Providence Portland Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org
PA
Allentown
Lehigh Valley Hospital-Cedar Crest
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org
Bethlehem
Lehigh Valley Hospital - Muhlenberg
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org
Danville
Geisinger Medical Center
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu
Hershey
Penn State Milton S Hershey Medical Center
Contact: Site Public Contact
Email: CTO@hmc.psu.edu
Philadelphia
Fox Chase Cancer Center
Contact: Site Public Contact
Temple University Hospital
Contact: Site Public Contact
University of Pennsylvania/Abramson Cancer Center
Contact: Site Public Contact
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Contact: Site Public Contact
West Reading
Reading Hospital
Contact: Site Public Contact
Williamsport
UPMC Susquehanna
Contact: Site Public Contact
RI
Providence
Miriam Hospital
Contact: Site Public Contact
Rhode Island Hospital
Contact: Site Public Contact
SC
Boiling Springs
Prisma Health Cancer Institute - Spartanburg
Contact: Site Public Contact
Email: kim.williams3@prismahealth.org
Charleston
Medical University of South Carolina
Contact: Site Public Contact
Email: hcc-clinical-trials@musc.edu
Ralph H Johnson VA Medical Center
Contact: Site Public Contact
Email: ashley.salvo@va.gov
Clinton
Prisma Health Cancer Institute - Laurens
Contact: Site Public Contact
Email: kim.williams3@prismahealth.org
Easley
Prisma Health Cancer Institute - Easley
Contact: Site Public Contact
Email: kim.williams3@prismahealth.org
Gaffney
Gibbs Cancer Center-Gaffney
Contact: Site Public Contact
Email: kmertz-rivera@gibbscc.org
Greenville
Prisma Health Cancer Institute - Butternut
Contact: Site Public Contact
Email: kim.williams3@prismahealth.org
Prisma Health Cancer Institute - Eastside
Contact: Site Public Contact
Email: kim.williams3@prismahealth.org
Prisma Health Cancer Institute - Faris
Contact: Site Public Contact
Email: kim.williams3@prismahealth.org
Saint Francis Cancer Center
Contact: Site Public Contact
Email: melissa_beckman@bshsi.org
Saint Francis Hospital
Contact: Site Public Contact
Email: melissa_beckman@bshsi.org
Greer
Gibbs Cancer Center-Pelham
Contact: Site Public Contact
Email: kmertz-rivera@gibbscc.org
Prisma Health Cancer Institute - Greer
Contact: Site Public Contact
Email: kim.williams3@prismahealth.org
Seneca
Prisma Health Cancer Institute - Seneca
Contact: Site Public Contact
Email: kim.williams3@prismahealth.org
Spartanburg
Spartanburg Medical Center
Contact: Site Public Contact
Email: kmertz-rivera@gibbscc.org
West Columbia
Lexington Medical Center
Contact: Site Public Contact
Email: LMCIRB@lexhealth.org
TN
Nashville
Meharry Medical College
Contact: Site Public Contact
Email: Nancy.McCullough@NashvilleHA.org
Vanderbilt University/Ingram Cancer Center
Contact: Site Public Contact
TX
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu
Fort Worth
UT Southwestern/Simmons Cancer Center-Fort Worth
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu
Galveston
University of Texas Medical Branch
Contact: Site Public Contact
Email: clinical.research@utmb.edu
Houston
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Contact: Site Public Contact
Email: burton@bcm.edu
Ben Taub General Hospital
Contact: Site Public Contact
League City
UTMB Cancer Center at Victory Lakes
Contact: Site Public Contact
Richardson
UT Southwestern Clinical Center at Richardson/Plano
Contact: Site Public Contact
Email: Suzanne.cole@utsouthwestern.edu
San Antonio
Audie L Murphy VA Hospital
Contact: Site Public Contact
University of Texas Health Science Center at San Antonio
Contact: Site Public Contact
Email: phoresearchoffice@uthscsa.edu
UT
Farmington
Farmington Health Center
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu
Salt Lake City
Huntsman Cancer Institute/University of Utah
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu
South Jordan
South Jordan Health Center
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu
VA
Charlottesville
University of Virginia Cancer Center
Contact: Site Public Contact
Email: uvacancertrials@hscmail.mcc.virginia.edu
Martinsville
Sovah Health Martinsville
Contact: Site Public Contact
Email: sharon.hubbard@lpnt.net
Mechanicsville
Bon Secours Memorial Regional Medical Center
Contact: Site Public Contact
Email: Jaime_scott@bshsi.org
Midlothian
Bon Secours Saint Francis Medical Center
Contact: Site Public Contact
Email: Jaime_scott@bshsi.org
Richmond
Bon Secours Saint Mary's Hospital
Contact: Site Public Contact
Email: Jaime_scott@bshsi.org
Virginia Commonwealth University/Massey Cancer Center
Contact: Site Public Contact
Email: klcampbell@vcu.edu
VT
Berlin
Central Vermont Medical Center/National Life Cancer Treatment
Contact: Site Public Contact
Burlington
University of Vermont Medical Center
Contact: Site Public Contact
Email: rpo@uvm.edu
University of Vermont and State Agricultural College
Contact: Site Public Contact
Email: rpo@uvm.edu
WA
Bremerton
Harrison HealthPartners Hematology and Oncology-Bremerton
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org
Kennewick
Kadlec Clinic Hematology and Oncology
Contact: Site Public Contact
Email: research@kadlecmed.org
Seattle
FHCC South Lake Union
Contact: Site Public Contact
Fred Hutchinson Cancer Center
Contact: Site Public Contact
University of Washington Medical Center - Montlake
Contact: Site Public Contact
WI
Antigo
Langlade Hospital and Cancer Center
Contact: Site Public Contact
Email: Juli.Alford@aspirus.org
Appleton
ThedaCare Regional Cancer Center
Contact: Site Public Contact
Email: ResearchDept@thedacare.org
Brookfield
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org
Burlington
Aurora Cancer Care-Southern Lakes VLCC
Contact: Site Public Contact
Email: ncorp@aurora.org
Eau Claire
Marshfield Medical Center-EC Cancer Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Fond Du Lac
Aurora Health Center-Fond du Lac
Contact: Site Public Contact
Email: ncorp@aurora.org
Franklin
Ascension Saint Francis - Reiman Cancer Center
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org
Germantown
Aurora Health Care Germantown Health Center
Contact: Site Public Contact
Email: ncorp@aurora.org
Grafton
Aurora Cancer Care-Grafton
Contact: Site Public Contact
Email: ncorp@aurora.org
Green Bay
Aurora BayCare Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org
Johnson Creek
University of Wisconsin Carbone Cancer Center - Johnson Creek
Contact: Site Public Contact
Email: lynda.persico@uwmf.wisc.edu
Kenosha
Aurora Cancer Care-Kenosha South
Contact: Site Public Contact
Email: ncorp@aurora.org
Madison
University of Wisconsin Carbone Cancer Center - University Hospital
Contact: Site Public Contact
William S Middleton VA Medical Center
Contact: Site Public Contact
Marinette
Aurora Bay Area Medical Group-Marinette
Contact: Site Public Contact
Email: ncorp@aurora.org
Marshfield
Marshfield Medical Center-Marshfield
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Medford
Aspirus Medford Hospital
Contact: Site Public Contact
Email: Beth.Knetter@aspirus.org
Milwaukee
Aurora Cancer Care-Milwaukee
Contact: Site Public Contact
Email: ncorp@aurora.org
Aurora Saint Luke's Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org
Aurora Sinai Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org
Medical College of Wisconsin
Contact: Site Public Contact
Minocqua
Marshfield Clinic-Minocqua Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Mukwonago
ProHealth D N Greenwald Center
Contact: Site Public Contact
Email: research.institute@phci.org
Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Contact: Site Public Contact
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Contact: Site Public Contact
Email: ncorp@aurora.org
Racine
Aurora Cancer Care-Racine
Contact: Site Public Contact
Email: ncorp@aurora.org
Rice Lake
Marshfield Medical Center-Rice Lake
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Contact: Site Public Contact
Email: ncorp@aurora.org
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Summit
Aurora Medical Center in Summit
Contact: Site Public Contact
Email: ncorp@aurora.org
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Contact: Site Public Contact
Email: ncorp@aurora.org
Waukesha
ProHealth Waukesha Memorial Hospital
Contact: Site Public Contact
UW Cancer Center at ProHealth Care
Contact: Site Public Contact
Email: Chanda.miller@phci.org
Wausau
Aspirus Regional Cancer Center
Contact: Site Public Contact
Marshfield Clinic-Wausau Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Wauwatosa
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org
Aurora Cancer Care-Milwaukee West
Contact: Site Public Contact
Email: ncorp@aurora.org
West Allis
Aurora West Allis Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org
Weston
Marshfield Medical Center - Weston
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Wisconsin Rapids
Aspirus Cancer Care - Wisconsin Rapids
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 A: 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 B: 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.