Active, Not Recruiting
An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma - CA209-374
Updated: 9 September, 2020 | ClinicalTrials.gov
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Trial Details
Phase
Gender(s)
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Active, Not Recruiting
Treatment Options
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Advanced or Metastatic renal cell carcinoma (RCC) - Predominant clear cell histology: 1. At least 1 but no more than 2 prior systemic anti vascular endothelial growth factor (anti-VEGF) treatments 2. No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting 3. Subjects with prior treatment with a mechanistic target of rapamycin (mTOR) are eligible - Non-clear cell histology: 0-3 prior systemic therapies and may include mTOR inhibitor - Brain metastases allowed if asymptomatic, without edema, and not receiving corticosteroids or radiation - Performance Status (PS): ≥ 70% Karnofsky Performance Scale (KPS) - All Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic scores allowed Exclusion Criteria: - Subjects with any active autoimmune disease or a history of known autoimmune disease - History of severe hypersensitivity reaction to other monoclonal antibodies - Prior malignancy, active within the last 3 years, except for locally curable cancers which have been apparently cured - Known HIV or AIDS-related illness - Any positive tests for Hepatitis B or Hepatitis C virus indicating acute or chronic infection
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