Status:
COMPLETED
Nivolumab (BMS-936558; MDX-1106) in Combination With Sunitinib, Pazopanib, or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma (RCC) (CheckMate 016)
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Ono Pharmaceutical Co. Ltd
Conditions:
Renal Cell Carcinoma
Clear-cell Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 carc...
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 9 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2021
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT01472081
Start Date
February 9 2012
End Date
June 3 2021
Last Update
December 2 2021
Active Locations (14)
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1
City Of Hope
Duarte, California, United States, 91010-3000
2
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States, 21287
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
4
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756