CheckMate 9ER — Nivolumab Plus Cabozantinib Versus Sunitinib in Previously Untreated Advanced Renal Cell Carcinoma (CheckMate 9ER)

Phase 3 · 2021 · Renal Cell Carcinoma

Design

Randomized open-label trial of nivolumab plus cabozantinib versus sunitinib.

Population

Previously untreated advanced or metastatic clear-cell renal cell carcinoma across IMDC risk groups.

Primary Endpoint

progression-free survival (PFS)

Key Result

Final analysis (median 5.6 yr): OS 46.5 vs 35.5 mo (HR 0.79); PFS 16.4 vs 8.3 mo (HR 0.58); ORR 55.7% vs 27.4%.

Guideline Impact

NCCN category 1 nivolumab plus cabozantinib for first-line advanced clear-cell RCC