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

Completed · Phase 1

Conditions studied: Renal Cell Carcinoma, Clear-cell Metastatic Renal Cell Carcinoma

In brief

The purpose is to determine the safety, effectiveness and best dose to use when giving Nivolumab in combination with Sunitinib, Pazopanib, or Ipilimumab for the treatment of metastatic renal cell carcinoma.

Key facts

Study ID

NCT01472081

Run by

Bristol-Myers Squibb

People needed

194

Starts

2012-02-09

Expected to finish

2021-06-03

Last updated by the study team

2021-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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
• Only prior cytokine based treatment for metastatic RCC [eg, interferon-alpha (IFN-alpha) or interleukin 2 (IL-2)] as prior therapy is allowed

You may not qualify if…

• 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

Where it is running

• City Of Hope — Duarte, California, United States
• Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Memorial Sloan Kettering Nassau — New York, New York, United States
• Blumenthal Cancer Center — Charlotte, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States
• University Of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
• Tom Baker Cancer Centre — Calgary, Alberta, Canada
• Cross Cancer Institute — Edmonton, Alberta, Canada
• BC Cancer Agency - Vancouver Centre — Vancouver, British Columbia, Canada
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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