Nivolumab in Treating Patients with Localized Kidney Cancer Undergoing Nephrectomy

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Status: Active

Description

This phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney) with or without nivolumab in treating patients with kidney cancer that is limited to a certain part of the body (localized). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab before nephrectomy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed, and after nephrectomy to increase survival. It is not yet known whether nivolumab and nephrectomy is more effective than nephrectomy alone in treating patients with kidney cancer.

Eligibility Criteria

Inclusion Criteria

  • ELIGIBILITY CRITERIA FOR PREREGISTRATION (STEP 0):
  • Patients with a renal mass consistent with a clinical stage >= T2Nx renal cell carcinoma (RCC) or TanyN+ RCC for which radical or partial nephrectomy is planned
  • Patients must have no clinical or radiological evidence of distant metastases (M0) unless the presumed M1 disease can be resected/definitively treated (e.g., thermal ablation, stereotactic radiation) at the same time or within a 12 week window from the date of the initial procedure such that the patient is considered “no evidence of disease” (M1 NED) * Permitted sites of oligo-metastases: lung, adrenal, nodes, pancreas, soft tissue or skin; liver or bone metastases are not permitted * No more than 3 metastases are permitted and all must be able to be removed or definitively treated within 12 weeks of the primary tumor resection
  • If histological confirmation of RCC has not been done within 12 months prior to pre-registration (Step 0), patient must be willing to undergo a core biopsy for this purpose if randomized to Arm H * NOTE: This can be a (1) standard of care diagnostic biopsy or (2) a research biopsy following assignment to Arm H or a planned metastasectomy before or after randomization; if the biopsy performed following pre-registration (Step 0) clearly demonstrates a benign condition, oncocytoma or a different type of cancer that is not RCC, the patient is not eligible for registration (Step 1); a non-diagnostic biopsy is considered a good faith effort and does not need to be repeated unless deemed clinically necessary by the treating investigator * NOTE: Patients randomized to Arm O (Observation) are permitted to register to Step 1 (Arm B) immediately following pre-registration assignment to Arm O, regardless of whether or not they have had a standard of care diagnostic biopsy
  • No prior systemic or local anti-cancer therapy for the current RCC is permitted * Partial nephrectomy for prior RCC * Metastasectomy for the current RCC diagnosis is not allowed unless performed to render patient NED (in addition to the planned nephrectomy) within 6 months of the current diagnosis * Radiation therapyto the bilateral kidney or any distant metastatic sites, is not allowed unless administered to render patient NED within 6 months of the current diagnosis * Current or past antineoplastic systemic therapies for RCC are not allowed: i.e., chemotherapy, hormonal therapy, immunotherapy, or standard or investigational agents for treatment of RCC * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1
  • Patient must have no prior history of RCC that was resected with curative intent within the past 5 years * Patients with a prior RCC that was treated > 5 years before, are eligible if the current tumor is consistent with a new primary in the opinion of the treating investigator * Patients with bilateral synchronous RCCs are eligible if they can be resected or definitively treated at the same time or within a 12 week window from time of initial nephrectomy (partial or radical) or procedure and maintain adequate residual renal function; the patient is not eligible if both kidneys are completely removed and subsequent hemodialysis is required ** Permitted forms of local therapy for second tumor: *** Partial or radical nephrectomy *** If tumor is =< 3cm: thermal ablation (e.g., radiofrequency ablation, cryoablation or stereotactic radiosurgery)
  • Patients cannot have concurrent malignancies, with the following exceptions: * Adequately treated basal cell or squamous cell skin cancer * In situ cervical cancer ** A history of superficial Ta urothelial cancer is permitted (as long as not currently undergoing treatment) whereas T1 or greater disease is excluded if < 3 years from diagnosis; concurrent persistent disease is not permitted ** Adequately treated stage I or II cancer from which the patient is currently in complete remission ** Any other cancer and stage from which the patient has been disease-free for at least 3 years prior to the time of pre-registration and as long as they are not receiving any current treatment (e.g. adjuvant or maintenance systemic or local therapy) ** Concurrent low risk prostate cancer on active surveillance
  • No active known or suspected autoimmune disease; the following autoimmune disorders are permitted: patients with vitiligo, type I diabetes mellitus, controlled/stable hypothyroidism due to autoimmune or non-autoimmune conditions (hormone replacement is allowed), psoriasis not requiring systemic treatment, or other conditions not expected to recur
  • No ongoing condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications with the exceptions outlined below; no treatment with other immunosuppressive agents within 14 days prior to the first dose of study drug with the following exceptions: * Topical, ocular, intra-articular, intranasal, inhaled steroids and adrenal replacement steroid doses > 10 mg daily prednisone or the equivalent are permitted in the absence of active autoimmune disease * A brief (less than 3 weeks) course of corticosteroids (any amount) for prophylaxis (for example: contrast dye allergy) or for treatment of non-autoimmune conditions (for example: nausea, delayed-type hypersensitivity reaction caused by a contact allergen) is permitted
  • No uncontrolled adrenal insufficiency
  • No known chronic active liver disease or evidence of acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • No serious intercurrent illness, including ongoing or active infection requiring parenteral antibodies
  • No known evidence of human immunodeficiency virus (HIV) infection, since the effects of nivolumab on anti-retroviral therapy have not been studied
  • No known medical condition (e.g. a condition associated with uncontrolled diarrhea such as ulcerative colitis or acute diverticulitis) that, in the investigator’s opinion, would increase the risk associated with study participation or interfere with the interpretation of safety results
  • No major surgery within 28 days prior to randomization
  • No patients currently enrolled in other clinical trials testing a therapeutic intervention
  • No history of severe hypersensitivity to a monoclonal antibody
  • Ability to understand and the willingness to sign a written informed consent document
  • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1):
  • Patients must meet all Step 0 eligibility criteria at the time of their registration to Step 1
  • In patients randomized to Arm H, core tumor biopsy must demonstrate RCC of any histology, including sarcomatoid, unclassified, or “unknown histology” (if preoperative biopsy was uninformative) * NOTE: A non-diagnostic biopsy is considered a good faith effort and does not need to be repeated unless deemed clinically necessary by the treating investigator
  • Women must not be pregnant or breast-feeding, as the effects of nivolumab on the developing human fetus or in the nursing infant are unknown; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point 2) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must use accepted and effective method(s) of contraception, or to abstain from sexual intercourse for the duration of their participation in the study; women of childbearing potential must use adequate methods to avoid pregnancy for 23 weeks after the last dose of nivolumab; sexually active males must use adequate methods to avoid pregnancy for 31 weeks after the last dose of nivolumab
  • White blood cells >= 2000/uL (within 8 weeks of registration)
  • Absolute neutrophil count (ANC) >= 1,500/mm^3 (within 8 weeks of registration)
  • Platelet count >= 100,000/mm^3 (within 8 weeks of registration)
  • Hemoglobin >= 9.0 g/dL (within 8 weeks of registration)
  • Serum creatinine =< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 x ULN) (within 8 weeks of registration)
  • Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 x ULN) (within 8 weeks of registration)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN (within 8 weeks of registration)

Locations & Contacts

Arizona

Phoenix
University of Arizona Cancer Center at Saint Joseph's
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Tucson
Banner University Medical Center - Tucson
Status: Active
Contact: Site Public Contact
Email: aselegue@email.arizona.edu
University of Arizona Cancer Center-North Campus
Status: Active
Contact: Site Public Contact
Phone: 800-327-2873

California

Anaheim
Kaiser Permanente-Anaheim
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Auburn
Sutter Auburn Faith Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Bakersfield
AIS Cancer Center at San Joaquin Community Hospital
Status: Active
Contact: Site Public Contact
Phone: 661-323-4673
Baldwin Park
Kaiser Permanente-Baldwin Park
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Bellflower
Kaiser Permanente-Bellflower
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Berkeley
Alta Bates Summit Medical Center-Herrick Campus
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Fontana
Kaiser Permanente-Fontana
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Harbor City
Kaiser Permanente - Harbor City
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Irvine
Kaiser Permanente-Irvine
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 858-822-5354
Email: cancercto@ucsd.edu
Los Angeles
Cedars Sinai Medical Center
Status: Active
Contact: Site Public Contact
Phone: 310-423-8965
Kaiser Permanente Los Angeles Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Kaiser Permanente-Cadillac
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 888-798-0719
USC / Norris Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 323-865-0451
Marysville
Fremont - Rideout Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 530-749-4400
Mountain View
Palo Alto Medical Foundation-Camino Division
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Oakland
Kaiser Permanente-Oakland
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Ontario
Kaiser Permanente-Ontario
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Palo Alto
Palo Alto Medical Foundation Health Care
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Panorama City
Kaiser Permanente - Panorama City
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Riverside
Kaiser Permanente-Riverside
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Roseville
Kaiser Permanente-Roseville
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sutter Roseville Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Sacramento
Kaiser Permanente - Sacramento
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Kaiser Permanente Downtown Commons
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: kpoct@kp.org
Sutter Medical Center Sacramento
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 916-454-6500
Email: cancerinfo@sutterhealth.org
University of California Davis Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 916-734-3089
San Diego
Kaiser Permanente-San Diego Zion
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
San Francisco
California Pacific Medical Center-Pacific Campus
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Kaiser Permanente-San Francisco
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Jose
Kaiser Permanente-Santa Teresa-San Jose
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Leandro
Kaiser Permanente San Leandro
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Marcos
Kaiser Permanente-San Marcos
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Santa Cruz
Palo Alto Medical Foundation-Santa Cruz
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
South San Francisco
Kaiser Permanente-South San Francisco
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sunnyvale
Palo Alto Medical Foundation-Sunnyvale
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Truckee
Gene Upshaw Memorial Tahoe Forest Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 530-582-6450
Vallejo
Kaiser Permanente-Vallejo
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sutter Solano Medical Center / Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Walnut Creek
Kaiser Permanente-Walnut Creek
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Whittier
Presbyterian Intercommunity Hospital
Status: Active
Contact: Site Public Contact
Phone: 562-698-0811
Woodland Hills
Kaiser Permanente-Woodland Hills
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org

Colorado

Colorado Springs
UCHealth Memorial Hospital Central
Status: Active
Contact: Site Public Contact
Phone: 719-365-2406
Fort Collins
Poudre Valley Hospital
Status: Active
Contact: Site Public Contact
Phone: 970-297-6150

Connecticut

Hartford
Hartford Hospital
Status: Active
Contact: Site Public Contact
Phone: 860-545-5363
Meriden
Midstate Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 866-662-5678
New Britain
The Hospital of Central Connecticut
Status: Active
Contact: Site Public Contact
Phone: 860-224-5660
New Haven
Yale University
Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu
Norwich
Eastern Connecticut Hematology and Oncology Associates
Status: Active
Contact: Site Public Contact
Phone: 860-886-8362

District of Columbia

Washington
George Washington University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 202-741-2981

Florida

Fort Lauderdale
Holy Cross Hospital
Status: Active
Contact: Site Public Contact
Phone: 954-267-7750
Lakeland
The Watson Clinic
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 863-680-7780

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 404-778-1868
Decatur
Atlanta VA Medical Center
Status: Active
Contact: Site Public Contact
Phone: 404-321-6111ext7632

Hawaii

Aiea
Pali Momi Medical Center
Status: Active
Contact: Site Public Contact
Phone: 808-486-6000
Honolulu
Hawaii Cancer Care Inc-POB II
Status: Active
Contact: Site Public Contact
Phone: 808-524-6115
Hawaii Oncology Inc-Kuakini
Status: Active
Contact: Site Public Contact
Phone: 808-531-8521
Queen's Medical Center
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Straub Clinic and Hospital
Status: Active
Contact: Site Public Contact
Phone: 808-522-4333

Idaho

Boise
Saint Luke's Mountain States Tumor Institute
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Fruitland
Saint Luke's Mountain States Tumor Institute - Fruitland
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Meridian
Saint Luke's Mountain States Tumor Institute - Meridian
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Nampa
Saint Luke's Mountain States Tumor Institute - Nampa
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Twin Falls
Saint Luke's Mountain States Tumor Institute-Twin Falls
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Illinois

Bloomington
Illinois CancerCare-Bloomington
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Canton
Illinois CancerCare-Canton
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Carthage
Illinois CancerCare-Carthage
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Chicago
Northwestern University
Status: Active
Contact: Site Public Contact
Phone: 312-695-1301
Email: cancer@northwestern.edu
Rush University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 312-942-5498
Email: clinical_trials@rush.edu
University of Chicago Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 773-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Effingham
Crossroads Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Elmhurst
Elmhurst Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 630-758-5460
Email: Jrohde@emhc.org
Eureka
Illinois CancerCare-Eureka
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Galesburg
Illinois CancerCare-Galesburg
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Geneva
Northwestern Medicine Cancer Center Delnor
Status: Active
Contact: Site Public Contact
Phone: 630-315-1918
Email: Claudine.Gamster@CadenceHealth.org
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Macomb
Illinois CancerCare-Macomb
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Maywood
Loyola University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 708-226-4357
Naperville
Edward Hospital / Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 630-646-6075
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Pekin
Illinois CancerCare-Pekin
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peoria
Illinois CancerCare-Peoria
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peru
Illinois CancerCare-Peru
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Plainfield
Edward Hospital / Cancer Center?Plainfield
Status: Active
Contact: Site Public Contact
Phone: 630-646-6075
Email: Cancerresearch@edward.org
Princeton
Illinois CancerCare-Princeton
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Springfield
Springfield Clinic
Status: Active
Contact: Site Public Contact
Phone: 800-444-7541
Swansea
Cancer Care Specialists of Illinois-Swansea
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: Active
Contact: Site Public Contact
Phone: 630-315-1918
Email: Claudine.Gamster@CadenceHealth.org

Indiana

Fort Wayne
Parkview Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 877-784-4673
Indianapolis
Franciscan Health Indianapolis
Status: Active
Contact: Site Public Contact
Phone: 317-528-7060
Indiana University / Melvin and Bren Simon Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 317-278-5632
Email: iutrials@iu.edu
Sidney and Lois Eskenazi Hospital
Status: Active
Contact: Site Public Contact
Phone: 317-278-5632
Email: iutrials@iu.edu
Mooresville
Franciscan Health Mooresville
Status: Active
Contact: Site Public Contact
Phone: 317-834-3603
Richmond
Reid Health
Status: Active
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu

Iowa

Ames
Mary Greeley Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
McFarland Clinic PC - Ames
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
Boone
McFarland Clinic PC-Boone
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Mercy Cancer Center-West Lakes
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Des Moines
Medical Oncology and Hematology Associates-Laurel
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Mercy Medical Center - Des Moines
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
Jefferson
McFarland Clinic PC-Jefferson
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
Marshalltown
McFarland Clinic PC-Marshalltown
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
West Des Moines
Mercy Medical Center-West Lakes
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org

Kansas

Hays
Hays Medical Center
Status: Active
Contact: Site Public Contact
Phone: 785-623-5774
Kansas City
University of Kansas Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Olathe
Olathe Medical Center
Status: Active
Contact: Site Public Contact
Phone: 913-791-3500
Email: Jeni.wakefield@olathehealth.org
Overland Park
University of Kansas Cancer Center-Overland Park
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Pittsburg
Via Christi Hospital-Pittsburg
Status: Active
Contact: Site Public Contact
Phone: 620-235-7900
Salina
Salina Regional Health Center
Status: Active
Contact: Site Public Contact
Phone: 785-452-7038
Email: kkavoura@srhc.com
Topeka
Saint Francis Hospital and Medical Center - Topeka
Status: Active
Contact: Site Public Contact
Phone: 785-295-8000
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 859-257-3379

Louisiana

Baton Rouge
Louisiana Hematology Oncology Associates LLC
Status: Active
Contact: Site Public Contact
Phone: 225-215-1353
Email: clinicalresearch@marybird.com
LSU Health Baton Rouge-North Clinic
Status: Active
Contact: Site Public Contact
Phone: 225-215-1353
Email: clinicalresearch@marybird.com
Mary Bird Perkins Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 225-215-1353
Email: clinicalresearch@marybird.com
Our Lady of the Lake Physicians Group - Medical Oncology
Status: Active
Contact: Site Public Contact
Phone: 225-757-0343
Email: clinicalresearch@marybird.com
Covington
Northshore Oncology Associates-Covington
Status: Active
Contact: Site Public Contact
Phone: 225-215-1353
Email: clinicalresearch@marybird.com
Houma
Oncology Center of The South Incorporated
Status: Active
Contact: Site Public Contact
Phone: 225-215-1353
Email: clinicalresearch@marybird.com
Metairie
East Jefferson General Hospital
Status: Active
Contact: Site Public Contact
Phone: 504-210-3539
Email: emede1@lsuhsc.edu
New Orleans
Louisiana State University Health Science Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 504-210-3539
Email: emede1@lsuhsc.edu
Ochsner Medical Center Jefferson
Status: Active
Contact: Site Public Contact
Phone: 504-703-8712
Email: Gregory.Johnstone@ochsner.org

Maine

Augusta
Harold Alfond Center for Cancer Care
Status: Active
Contact: Site Public Contact
Phone: 207-626-4855
Bangor
Eastern Maine Medical Center
Status: Active
Contact: Site Public Contact
Phone: 207-973-4274
Belfast
Waldo County General Hospital
Status: Active
Contact: Site Public Contact
Phone: 207-338-2500
Biddeford
MaineHealth / SMHC Cancer Care and Blood Disorders-Biddeford
Status: Active
Contact: Site Public Contact
Email: LLemire@mmc.org
Brewer
Lafayette Family Cancer Center-EMMC
Status: Active
Contact: Site Public Contact
Phone: 800-987-3005
Rockport
Penobscot Bay Medical Center
Status: Active
Contact: Site Public Contact
Phone: 207-396-8670
Email: ClinicalResearch@mmc.org
Sanford
MaineHealth / SMHC Cancer Care and Blood Disorders-Sanford
Status: Active
Contact: Site Public Contact
Email: LLemire@mmc.org
South Portland
Maine Medical Partners - South Portland
Status: Active
Contact: Site Public Contact
Phone: 207-396-8670
Email: ClinicalResearch@mmc.org

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 410-955-8804
Email: jhcccro@jhmi.edu

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Active
Contact: Site Public Contact
Phone: 617-667-9925
Boston Medical Center
Status: Active
Contact: Site Public Contact
Phone: 617-638-8265
Brigham and Women's Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Dana-Farber Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 877-442-3324
Massachusetts General Hospital Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-726-5130
Burlington
Lahey Hospital and Medical Center
Status: Active
Contact: Site Public Contact
Phone: 781-744-8027
Winchester
Winchester Hospital
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Worcester
University of Massachusetts Medical School
Status: Active
Contact: Site Public Contact
Phone: 508-856-3216
Email: cancer.research@umassmed.edu

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
University of Michigan Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-865-1125
Brighton
Saint Joseph Mercy Brighton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Canton
Saint Joseph Mercy Canton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Chelsea
Saint Joseph Mercy Chelsea
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Detroit
Wayne State University / Karmanos Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Farmington Hills
Weisberg Cancer Treatment Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Lansing
Sparrow Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Royal Oak
William Beaumont Hospital-Royal Oak
Status: Active
Contact: Site Public Contact
Phone: 248-551-7695
Troy
William Beaumont Hospital - Troy
Status: Active
Contact: Site Public Contact
Phone: 248-551-7695

Minnesota

Rochester
Mayo Clinic
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015

Mississippi

Jackson
University of Mississippi Medical Center
Status: Active
Contact: Site Public Contact
Phone: 601-815-6700

Missouri

Cape Girardeau
Saint Francis Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Columbia
University of Missouri - Ellis Fischel
Status: Active
Contact: Site Public Contact
Phone: 573-882-7440
Kansas City
Truman Medical Center
Status: Active
Contact: Site Public Contact
Phone: 816-404-4375
Lee's Summit
The University of Kansas Cancer Center-Lee's Summit
Status: Active
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Montana

Bozeman
Bozeman Deaconess Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Nebraska

Grand Island
CHI Health Saint Francis
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Omaha
Nebraska Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 402-354-5144

Nevada

Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
OptumCare Cancer Care at Fort Apache
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
University Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Reno
Renown Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org

New Jersey

Hackensack
Hackensack University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 201-996-2879
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Contact: Site Public Contact
Phone: 732-235-8675
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 732-235-8675

New York

Bronx
James J Peters VA Medical Center
Status: Active
Contact: Site Public Contact
Phone: 718-584-9000
Email: kl2965@cumc.columbia.edu
Montefiore Medical Center - Moses Campus
Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Montefiore Medical Center-Einstein Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Montefiore Medical Center-Weiler Hospital
Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Glens Falls
Glens Falls Hospital
Status: Active
Contact: Site Public Contact
Phone: 518-926-6700
Lake Success
Northwell Health / Center for Advanced Medicine
Status: Active
Contact: Site Public Contact
Phone: 516-734-8896
New Hyde Park
Long Island Jewish Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 516-734-8896
New York
NYP / Weill Cornell Medical Center
Status: Active
Contact: Site Public Contact
Phone: 212-746-1848
White Plains
Dickstein Cancer Treatment Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 914-849-7582
Email: mcortese@wphospital.org

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu
Clinton
Southeastern Medical Oncology Center-Clinton
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 919-587-9077
Email: ecooke@cancersmoc.com
Durham
Duke University Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-275-3853
Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 919-587-9077
Email: ecooke@cancersmoc.com
Wayne Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 919-731-6687
Email: ecooke@cancersmoc.com
Jacksonville
Onslow Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 910-353-0824
Email: ecooke@cancersmoc.com
Southeastern Medical Oncology Center-Jacksonville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 910-353-0824
Email: ecooke@cancersmoc.com
Kenansville
Vidant Oncology-Kenansville
Status: Active
Contact: Site Public Contact
Phone: 252-559-2201
Email: Carla.Zimmerman@vidanthealth.com
Kinston
Vidant Oncology-Kinston
Status: Active
Contact: Site Public Contact
Phone: 252-559-2201
Email: Carla.Zimmerman@vidanthealth.com
Richlands
Vidant Oncology-Richlands
Status: Active
Contact: Site Public Contact
Phone: 252-559-2201
Email: Carla.Zimmerman@vidanthealth.com
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Fargo
Sanford Broadway Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Sanford Roger Maris Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 701-234-6161
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Ohio

Cincinnati
Bethesda North Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Good Samaritan Hospital - Cincinnati
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
University of Cincinnati / Barrett Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 513-558-4553
Email: uchealthnews@uc.edu
Kettering
Kettering Medical Center
Status: Active
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Toledo
Toledo Clinic Cancer Centers-Toledo
Status: Active
Contact: Site Public Contact
Phone: 800-444-3561
West Chester
University Pointe
Status: Active
Contact: Site Public Contact
Email: clinicaltrials@ucphysicians.com

Oklahoma

Oklahoma City
Mercy Hospital Oklahoma City
Status: Active
Contact: Site Public Contact
Phone: 405-752-3402
University of Oklahoma Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Oregon

Clackamas
Providence Oncology and Hematology Care Southeast
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Newberg
Providence Newberg Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Oregon City
Providence Willamette Falls Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Portland
Providence Portland Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org

Pennsylvania

Allentown
Lehigh Valley Hospital-Cedar Crest
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Bethlehem
Lehigh Valley Hospital - Muhlenberg
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Danville
Geisinger Medical Center
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
Hershey
Penn State Milton S Hershey Medical Center
Status: Active
Contact: Site Public Contact
Phone: 717-531-3779
Email: CTO@hmc.psu.edu
Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-474-9892
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Contact: Site Public Contact
Phone: 412-647-8073
West Reading
Reading Hospital
Status: Active
Contact: Site Public Contact
Phone: 610-988-9323
Williamsport
UPMC Susquehanna
Status: Active
Contact: Site Public Contact
Phone: 800-598-4282

Rhode Island

Providence
Miriam Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 401-793-2224
Rhode Island Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 401-444-1488

South Carolina

Clinton
Greenville Health System Cancer Institute-Laurens
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Easley
Greenville Health System Cancer Institute-Easley
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville
Greenville Health System Cancer Institute-Butternut
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville Health System Cancer Institute-Eastside
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville Health System Cancer Institute-Faris
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Saint Francis Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 864-603-6213
Email: meissa_beckman@bshsi.org
Saint Francis Hospital
Status: Active
Contact: Site Public Contact
Phone: 864-603-6213
Email: meissa_beckman@bshsi.org
Greer
Greenville Health System Cancer Institute-Greer
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Seneca
Greenville Health System Cancer Institute-Seneca
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Spartanburg
Greenville Health System Cancer Institute-Spartanburg
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-811-8480

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Site Public Contact
Phone: 214-648-7097
Email: canceranswerline@UTSouthwestern.edu
Fort Worth
UT Southwestern / Simmons Cancer Center-Fort Worth
Status: Active
Contact: Site Public Contact
Phone: 214-648-7097
Email: canceranswerline@UTSouthwestern.edu
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 713-798-1354
Email: burton@bcm.edu
Ben Taub General Hospital
Status: Active
Contact: Site Public Contact
Phone: 713-873-2000
Richardson
UT Southwestern Clinical Center at Richardson / Plano
Status: Active
Contact: Site Public Contact
Phone: 214-648-0225
Email: hrpp@utsouthwestern.edu
San Antonio
University of Texas Health Science Center at San Antonio
Status: Active
Contact: Site Public Contact
Phone: 210-450-3800
Email: phoresearchoffice@uthscsa.edu

Utah

Farmington
Farmington Health Center
Status: Active
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu
South Jordan
South Jordan Health Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu

Vermont

Berlin
Central Vermont Medical Center / National Life Cancer Treatment
Status: Active
Contact: Site Public Contact
Phone: 802-225-5400
Burlington
University of Vermont and State Agricultural College
Status: Active
Contact: Site Public Contact
Phone: 802-656-8990
Email: rpo@uvm.edu
University of Vermont Medical Center
Status: Active
Contact: Site Public Contact
Phone: 802-656-4101
Email: rpo@uvm.edu

Virginia

Martinsville
Sovah Health Martinsville
Status: Active
Contact: Site Public Contact
Phone: 276-666-7827
Email: sharon.hubbard@lpnt.net

Wisconsin

Antigo
Langlade Hospital and Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 715-623-9869
Email: Juli.Alford@aspirus.org
Burlington
Aurora Cancer Care-Southern Lakes VLCC
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Eau Claire
Marshfield Medical Center-EC Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Fond Du Lac
Aurora Health Center-Fond du Lac
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Germantown
Aurora Health Care Germantown Health Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Grafton
Aurora Cancer Care-Grafton
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Green Bay
Aurora BayCare Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Johnson Creek
UW Cancer Center Johnson Creek
Status: Active
Contact: Site Public Contact
Phone: 920-699-3500
Email: lynda.persico@uwmf.wisc.edu
Kenosha
Aurora Cancer Care-Kenosha South
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Site Public Contact
Phone: 800-622-8922
Marinette
Aurora Bay Area Medical Group-Marinette
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Marshfield
Marshfield Medical Center-Marshfield
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Milwaukee
Aurora Cancer Care-Milwaukee
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Aurora Saint Luke's Medical Center
Status: Active
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Aurora Sinai Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Froedtert and the Medical College of Wisconsin
Status: Active
Contact: Site Public Contact
Phone: 414-805-4380
Minocqua
Marshfield Clinic-Minocqua Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Mukwonago
ProHealth D N Greenwald Center
Status: Active
Contact: Site Public Contact
Email: research.institute@phci.org
Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 262-928-7878
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Racine
Aurora Cancer Care-Racine
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Rice Lake
Marshfield Medical Center-Rice Lake
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Stevens Point
Marshfield Clinic Stevens Point Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Summit
Aurora Medical Center in Summit
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Waukesha
ProHealth Waukesha Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 262-928-7632
UW Cancer Center at ProHealth Care
Status: Active
Contact: Site Public Contact
Phone: 262-928-5539
Email: Chanda.miller@phci.org
Wausau
Aspirus Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-405-6866
Marshfield Clinic-Wausau Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Wauwatosa
Aurora Cancer Care-Milwaukee West
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
West Allis
Aurora West Allis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Weston
Marshfield Clinic - Weston Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Wisconsin Rapids
Aspirus UW Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 715-422-7718

Israel

Haifa
Rambam Medical Center
Status: Active
Contact: Site Public Contact
Phone: 972-4-8541737
Email: y_rozen@rambam.health.gov.il
Jerusalem
Shaare Zedek Medical Center
Status: Active
Contact: Site Public Contact
Phone: 972-2-6666507

Trial Objectives and Outline

PRIMARY OBJECTIVES:

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 programmed cell death 1 ligand 1 (PD-L1) with outcome.

II. To correlate the expression of PD-L1 on tumor tissue at recurrence with outcome.

III. To archive images for 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 OBJECTIVES:

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 30-60 minutes on day 1. Treatment repeats every 14 days for 2 cycles. Patients then undergo partial or radical nephrectomy 7-28 days later. Patient then receive nivolumab over 30-60 IV on day 1. Treatment repeats every 14 days for 6 cycles, and then every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

Patients enrolled after Amendment 4 receive nivolumab IV over 30-60 minutes on day 1. Patients then undergo partial or radical nephrectomy 7-28 days later. Patient then receive nivolumab IV over 30-60 minutes on day 1. Treatment repeats every 4 weeks for 9 cycles in the absence of disease progression or unacceptable toxicity.

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.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
ECOG-ACRIN Cancer Research Group

Principal Investigator
Lauren Christine Harshman

Trial IDs

Primary ID EA8143
Secondary IDs NCI-2016-00326
Clinicaltrials.gov ID NCT03055013