A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Summary
This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival.
Timeline
- Start
- 2021-02-25
- Primary completion
- 2026-02-02
- Completion
- 2027-02-11
Outcome
Mixed primary results
release “The LITESPARK-011 study demonstrated a 30% reduction in the risk of disease progression or death with belzutifan plus lenvatinib compared to cabozantinib” merck.com ↗
release “WELIREG plus LENVIMA demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS)” merck.com ↗
release “A trend toward improvement in overall survival (OS), the trial’s other primary endpoint, was also observed for WELIREG plus LENVIMA” merck.com ↗
release “A trend toward improvement in overall survival (OS), the trial’s other primary endpoint, was also observed for WELIREG plus LENVIMA (HR=0.85 [95% CI, 0.68-1.05]; p=0.06075).” merck.com ↗
release “LITESPARK-011 trial. Results from a pre-specified interim analysis showed treatment with WELIREG plus LENVIMA led to a statistically significant” eisai.com ↗
release “progression-free survival (PFS), one of the dual primary endpoints” eisai.com ↗
release “At the final analysis, overall survival (OS), the study’s other primary endpoint, did not meet statistical significance” eisai.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belzutifan | Small molecule | 120 mg | Oral |
| Comparator | Cabozantinib | Small molecule | 60 mg | Oral |
| Subject | Lenvatinib | Small molecule | 20 mg | Oral |