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A Phase 1 Study of Nivolumab (BMS-936558) Plus Sunitinib, Pazopanib or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma

Phase 1
18 Years
Open (Enrolling)
Renal Cell Carcinoma, Clear-cell Metastatic Renal Cell Carcinoma

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Trial Information

A Phase 1 Study of Nivolumab (BMS-936558) Plus Sunitinib, Pazopanib or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma

For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email Please visit for more information on clinical trial participation

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)

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
- Serum creatinine >1.5x ULN or creatinine clearance <40 mL/min (Cockroft-Gault

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of Nivolumab plus Sunitinib, Pazopanib, or Ipilimumab measured by incidence of Adverse event (AE)

Outcome Time Frame:

up to 100 days after last dose or longer

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

February 2012

Completion Date:

May 2014

Related Keywords:

  • Renal Cell Carcinoma
  • Clear-cell Metastatic Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell



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Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
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Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756
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The University of Texas MD Anderson Cancer Center Houston, Texas  77030-4009
Levine Cancer Institute Charlotte, North Carolina  28211