NCT05030506

A Study of Belzutifan (MK-6482) as Monotherapy and in Combination With Lenvatinib (E7080/MK-7902) With or Without Pembrolizumab (MK-3475) in China Participants With Advanced Renal Cell Carcinoma (MK-6482-010)

An Open-Label, Phase 1 Study of MK-6482 as Monotherapy and in Combination With Lenvatinib (MK-7902) With or Without Pembrolizumab (MK-3475) in China Participants With Advanced Renal Cell Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles, and preliminary efficacy of belzutifan as monotherapy followed by belzutifan+lenvatinib combination therapy, as well as belzutifan combined with lenvatinib and pembrolizumab in China participants with advanced renal cell carcinoma.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Belzutifan	40 mg tablet administered orally at a dose of 120 mg
BIOLOGICAL	Pembrolizumab	25 mg/mL solution for Infusion in a single-dose vial administered intravenously at a dose of 400 mg
DRUG	Lenvatinib	10 mg capsule administered orally at a dose of 20 mg

Timeline

• Start date: 2021-10-13
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2021-09-01
• Last updated: 2025-12-18

Locations

5 sites across 1 country: China

Regulatory

• FDA-regulated drug study