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.
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
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There are 61 Locations for this study
Muscle Shoals Alabama, 35661, United States
Anchorage Alaska, 99503, United States
Chandler Arizona, 85224, United States
Fayetteville Arkansas, 72703, United States
Encinitas California, 92024, United States
Long Beach California, 90813, United States
Los Angeles California, 90017, United States
Los Angeles California, 90095, United States
Redondo Beach California, 90277, United States
Riverside California, 92505, United States
San Diego California, 92123, United States
San Luis Obispo California, 93401, United States
Santa Maria California, 93454, United States
Fort Myers Florida, 33901, United States
Miami Florida, 33136, United States
Orlando Florida, 32806, United States
Saint Petersburg Florida, 33705, United States
Atlanta Georgia, 30322, United States
Niles Illinois, 60714, United States
Fort Wayne Indiana, 46845, United States
Wichita Kansas, 67214, United States
Louisville Kentucky, 40202, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Minneapolis Minnesota, 55416, United States
Hattiesburg Mississippi, 39401, United States
Jackson Mississippi, 39202, United States
Kansas City Missouri, 64132, United States
Las Vegas Nevada, 89148, United States
Hackensack New Jersey, 07601, United States
Albuquerque New Mexico, 87106, United States
Bronx New York, 10461, United States
Brooklyn New York, 11220, United States
Grand Island New York, 68803, United States
Johnson City New York, 13790, United States
New York New York, 10016, United States
New York New York, 10021, United States
Syracuse New York, 13210, United States
Durham North Carolina, 27710, United States
Goldsboro North Carolina, 27534, United States
Tulsa Oklahoma, 74146, United States
Pittsburgh Pennsylvania, 15240, United States
Charleston South Carolina, 29414, United States
Charleston South Carolina, 29425, United States
Sioux Falls South Dakota, 57105, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Austin Texas, 78731, United States
Dallas Texas, 75246, United States
Fort Worth Texas, 76104, United States
Midland Texas, 79701, United States
San Antonio Texas, 78217, United States
Charlottesville Virginia, 22936, United States
Fairfax Virginia, 22031, United States
Midlothian Virginia, 23114, United States
Richmond Virginia, 23226, United States
Seattle Washington, 98109, United States
Spokane Washington, 99208, United States
Yakima Washington, 98902, United States
Madison Wisconsin, 53705, United States
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