Kidney Cancer Clinical Trial

A Study to Evaluate the Safety of Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Cancer

Summary

To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with previously untreated advanced or metastatic Renal Cell Cancer.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

1. Type of Participant and Target Disease Characteristics

Advanced or metastatic RCC
Histologically confirmed, previously untreated (treatment-naive) RCC
No prior systemic therapy for RCC except for one prior adjuvant or neoadjuvant therapy for completely resectable RCC
Measurable disease as per RECIST 1.1. Subject must have extracranial metastasis as measurable disease
Karnofsky Performance Status (KPS) of at least 70% for Cohort 1, 2, and 3; KPS of 50-60% for Cohort 4
Tumor tissue need be received by the central vendor (block or unstained slides). Note: Fine Needle Aspiration (FNA)and bone metastases samples are not acceptable for submission.

Exclusion Criteria:

Medical Conditions

Subjects with any active autoimmune disease or a history of known autoimmune disease
Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
Known HIV or AIDS-related illness
Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.

Prior/Concomitant Therapy

Prior systemic treatment in the metastatic setting with Vascular epithelial growth factor(VEGF) or VEGF receptor targeted therapy
Prior treatment with an anti-Programmed Death (PD) -1, anti-PD-L1, anti-PD-L2, anti-cluster of differentiation 137 (CD137), or anti-cytotoxic T-lymphocyte-associated antigen 4(CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. This includes the utilization of these agents in the neo-adjuvant or adjuvant setting.
Anti-cancer therapy less than 28 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug.

Other protocol defined inclusion/exclusion criteria apply

Study is for people with:

Kidney Cancer

Phase:

Phase 4

Estimated Enrollment:

211

Study ID:

NCT02982954

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 61 Locations for this study

See Locations Near You

Northwest Alabama Cancer Center, Pc
Muscle Shoals Alabama, 35661, United States
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage Alaska, 99503, United States
Ironwood Cancer And Research Centers, Pc
Chandler Arizona, 85224, United States
Local Institution - 0028
Fayetteville Arkansas, 72703, United States
eCare
Encinitas California, 92024, United States
Pacific Shores Medical Group
Long Beach California, 90813, United States
Los Angeles Cancer Network
Los Angeles California, 90017, United States
UCLA Hematology Oncology
Los Angeles California, 90095, United States
Torrance Health Association
Redondo Beach California, 90277, United States
Kaiser Permanente Medical Group - Southern California
Riverside California, 92505, United States
Sharp Memorial Hospital
San Diego California, 92123, United States
Coastal Integrative Cancer Care
San Luis Obispo California, 93401, United States
Central Coast Med Oncology
Santa Maria California, 93454, United States
Florida Cancer Specialists S.
Fort Myers Florida, 33901, United States
University Of Miami/Sylvester Cancer Center
Miami Florida, 33136, United States
UF Health Cancer Center at Orlando Health
Orlando Florida, 32806, United States
Florida Cancer Specialists
Saint Petersburg Florida, 33705, United States
Emory University - Winship Cancer Institute
Atlanta Georgia, 30322, United States
Illinois Cancer Specialists
Niles Illinois, 60714, United States
Local Institution - 0012
Fort Wayne Indiana, 46845, United States
Cancer Center Of Kansas
Wichita Kansas, 67214, United States
Norton Cancer Institute
Louisville Kentucky, 40202, United States
Southdale Cancer Clinic
Burnsville Minnesota, 55337, United States
Local Institution - 0009
Coon Rapids Minnesota, 55433, United States
Park Nicollet Clinic Cancer Center
Minneapolis Minnesota, 55416, United States
Hattiesburg Clinic
Hattiesburg Mississippi, 39401, United States
Jackson Oncology Associates, Pllc
Jackson Mississippi, 39202, United States
HCA Midwest Division
Kansas City Missouri, 64132, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89148, United States
Local Institution - 0023
Hackensack New Jersey, 07601, United States
University Of New Mexico
Albuquerque New Mexico, 87106, United States
Montefiore Medical Center
Bronx New York, 10461, United States
Maimonides Medical Center
Brooklyn New York, 11220, United States
St. Francis Cancer Treatment Center
Grand Island New York, 68803, United States
Broome Oncology
Johnson City New York, 13790, United States
Local Institution - 0052
New York New York, 10016, United States
Weill Cornell Medical College
New York New York, 10021, United States
SUNY Upstate Medical University
Syracuse New York, 13210, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Southeastern Medical Oncology Center
Goldsboro North Carolina, 27534, United States
Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research
Tulsa Oklahoma, 74146, United States
Local Institution - 0071
Pittsburgh Pennsylvania, 15240, United States
Charleston Hematology Oncology Associates, Pa
Charleston South Carolina, 29414, United States
Hollings Cancer Center
Charleston South Carolina, 29425, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Tennessee Oncology, PLLC - SCRI - PPDS
Chattanooga Tennessee, 37404, United States
Local Institution - 0002
Nashville Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Texas Oncology
Austin Texas, 78731, United States
Texas Oncology
Dallas Texas, 75246, United States
Texas Oncology-Fort Worth 12th Ave
Fort Worth Texas, 76104, United States
Texas Oncology-Midland Allison Cancer Center
Midland Texas, 79701, United States
Texas Oncology
San Antonio Texas, 78217, United States
University of Virginia Health System
Charlottesville Virginia, 22936, United States
Local Institution - 0042
Fairfax Virginia, 22031, United States
Bon Secours St Francis Hospital
Midlothian Virginia, 23114, United States
Virginia Cancer Institute
Richmond Virginia, 23226, United States
University of Washington - Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Medical Oncology Associates
Spokane Washington, 99208, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima Washington, 98902, United States
University of Wisconsin Clinical Science Center
Madison Wisconsin, 53705, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 4

Estimated Enrollment:

211

Study ID:

NCT02982954

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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