CLEAR — Lenvatinib Plus Everolimus or Lenvatinib Plus Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma

Phase 3 · 2021 · Renal Cell Carcinoma

Design

Three-arm randomized trial: lenvatinib plus pembrolizumab vs. lenvatinib plus everolimus vs. sunitinib.

Population

Previously untreated advanced clear-cell RCC across all IMDC risk groups.

Primary Endpoint

progression-free survival (PFS)

Key Result

Final analysis: lenvatinib+pembrolizumab median PFS 23.9 vs 9.2 mo (HR 0.39); ORR 71.3% vs 36.1%; median OS 53.7 vs 54.3 mo (HR 0.79, 95% CI 0.63–0.99) — near-identical OS medians reflect extensive control-arm crossover to subsequent therapy.

Guideline Impact

NCCN preferred first-line for advanced clear-cell RCC