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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)
Sponsor: Merck Sharp & Dohme LLC
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2021-10-13
Completion Date
2027-06-30
Last Updated
2025-12-18
Healthy Volunteers
No
Conditions
Interventions
Belzutifan
40 mg tablet administered orally at a dose of 120 mg
Pembrolizumab
25 mg/mL solution for Infusion in a single-dose vial administered intravenously at a dose of 400 mg
Lenvatinib
10 mg capsule administered orally at a dose of 20 mg
Locations (5)
Beijing Cancer hospital-Digestive Oncology ( Site 0001)
Beijing, Beijing Municipality, China
SUN YAT-SEN UNIVERSITY CANCER CENTRE-Urology Surgery Department ( Site 0005)
Guangzhou, Guangdong, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
Nanjing, Jiangsu, China
Tianjin Medical University Cancer Institute and Hospital ( Site 0003)
Tianjin, Tianjin Municipality, China
The Second Affiliated hospital of Zhejiang University school of medicine-Urology ( Site 0007)
Hangzhou, Zhejiang, China