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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

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 4

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Nivolumab
Drug: Nivolumab

Key Eligibility Criteria

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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com