Bristol-Myers Squibb CA209-374

A phase 3b/4 trial of nivolumab (BMS-936558) in subjects with advanced or metastatic renal cell carcinoma (Checkmate 374: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluate 374)

NCT02596035

Kidney Cancer, Renal Cell Carcinoma, Clear Cell Carcinoma; Non-clear cell carcinoma

Stage 4

Metastatic/Palliative

2nd or 3rd line (after at least 1 VEGF inhibitor)

Nivolumab

PD-1 inhibitor

Brad Somer, MD

Bristol-Myers Squibb

Phase 4

Closed to Accrual

NCT02596035

• Advanced or metastatic RCC
• For Clear cell histology:
  • At least 1 but no more than 2 prior systemic anti-VEGF treatments
  • No more than 3 total prior systemic treatment regimens in the advanced/metastatic setting
  • No prior treatment with an mTOR inhibitor
• For Non-Clear Cell Histology
  • 0-2 prior therapies (1st line-3rd line)
  • Prior mTOR inhibitor is allowed
• CNS Disease is allowed if asymptomatic, no edema, and not on steroids
• KPS >70%
• No history of autoimmune disease
• No prior malignancy within 3 years except for curable cancers that are apparently cured
• No known HIV, HBV, or HCV

Primary- Rate of immune mediated adverse events. Secondary- Time to onset of imAE, time to resolution of imAE, rate of medication for imAE

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Clear cell or non-clear cell

No