Clinical Trial: NCT04586231
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Merck Sharp & Dohme LLC |
| Information Provided By: | Merck Sharp & Dohme LLC |
| Last Update Posted: | 2026-05-05 |
Study Overview
Brief 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.
Official Title
An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination With Lenvatinib (MK-7902) vs Cabozantinib in Participants With Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti-PD-1/L1 Therapy
Conditions
Carcinoma, Renal Cell
Intervention / Treatment
- Drug: Belzutifan
- Drug: Lenvatinib
- Drug: Cabozantinib
Other Study ID Numbers
- 6482-011
- MK-6482-011
- jRCT2031210311
- 2024-510620-39-00
- U1111-1302-2815
- 2020-002075-35
Start Date (Actual)
2021-02-25
Primary Completion Date (Actual)
2026-02-02
Study Completion Date (Estimated)
2027-02-11
Enrollment (Actual)
747
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Merck Sharp & Dohme LLC |
| Information Provided By: | Merck Sharp & Dohme LLC |
| Last Update Posted: | 2026-05-05 |
Study Overview
Brief 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.
Official Title
An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination With Lenvatinib (MK-7902) vs Cabozantinib in Participants With Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti-PD-1/L1 Therapy
Conditions
Carcinoma, Renal Cell
Intervention / Treatment
- Drug: Belzutifan
- Drug: Lenvatinib
- Drug: Cabozantinib
Other Study ID Numbers
- 6482-011
- MK-6482-011
- jRCT2031210311
- 2024-510620-39-00
- U1111-1302-2815
- 2020-002075-35
Start Date (Actual)
2021-02-25
Primary Completion Date (Actual)
2026-02-02
Study Completion Date (Estimated)
2027-02-11
Enrollment (Actual)
747
Study Type
Interventional
Phase
Phase 3