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ACTIVE NOT RECRUITING
NCT05030506
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

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

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