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Active, Not Recruiting

Nivolumab (BMS-936558; MDX-1106) in Combination With Sunitinib, Pazopanib, or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma (RCC) (CheckMate 016) - CA209-016

Updated: 20 April, 2020   |   ClinicalTrials.gov

Print Friendly Summary

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 1


  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
Experimental: Arm I-1: Nivolumab + Ipilimumab
Biological: Nivolumab Biological: Ipilimumab
Experimental: Arm I-3: Nivolumab + Ipilimumab
Biological: Ipilimumab Biological: Nivolumab
Experimental: Arm IN-3: Nivolumab+Ipilimumab
Biological: Ipilimumab Biological: Nivolumab
Experimental: Arm P: Nivolumab + Pazopanib
Biological: Pazopanib Biological: Nivolumab
Experimental: Arm S: Nivolumab + Sunitinib
Biological: Nivolumab Drug: Sunitinib

Key Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Subjects with histological confirmation of RCC - Advanced or metastatic disease - Measurable disease as defined by RECIST 1.1 criteria - Karnofsky Performance Status (KPS) ≥80% - Available tumor tissue (archival or recent acquisition) - Subjects enrolled in the I-1, I-3 expansion arms and IN-3 addition arms must not have received any prior systemic therapy for RCC with the following exceptions: 1. One prior adjuvant or neoadjuvant therapy for localized or locally advanced RCC is allowed provided recurrence occurred ≥ 6 months after the last dose of the adjuvant or neoadjuvant therapy 2. Only prior cytokine based treatment for metastatic RCC [eg, interferon-alpha (IFN-alpha) or interleukin 2 (IL-2)] as prior therapy is allowed Exclusion Criteria: - Active central nervous system (CNS) metastases - Active or history of autoimmune disease - Ongoing symptomatic cardiac dysrhythmias or uncontrolled atrial fibrillation - History of cerebrovascular accident including transient ischemic attack within the past 12 months - History of pulmonary embolism or deep vein thrombosis (DVT) within the past 6 months - Chronic systemic steroids (>10 mg/day Prednisone equivalents) or any other immunosuppressive agents - White blood cell (WBC) <2,000/mm3 - Neutrophiles <1,500/mm3 - Platelets <100,000/mm3 - Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >3x upper limit of normal (ULN) - Total Bilirubin >1.5x ULN (except subjects with Gilbert syndrome, total bilirubin <3.0 mg/dL) - Cardiac ejection fraction <LLN (lower limit of normal) - Serum creatinine >1.5x ULN or creatinine clearance <40 mL/min (Cockroft-Gault formula) Exclusion Criteria for Arm S and Arm P only: - For dose escalation cohorts - subjects who received prior Sunitinib or Pazopanib and required permanent discontinuation due to toxicity or required dose reduction or delay during the first 12 weeks of therapy due to toxicity, or received both prior Sunitinib and Pazopanib - Poorly controlled hypertension - Active bleeding or bleeding susceptibility

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Side Effects (Adverse Events) and other reportable events are defined here
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