drugset / Trial / NCT04976634

Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016)

NCT04976634

Phase 2 Active not recruiting 730 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the safety and efficacy of belzutifan in combination with pembrolizumab and lenvatinib in multiple solid tumors including hepatocellular carcinoma (HCC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer (BTC), endometrial cancer (EC),and esophageal squamous cell carcinoma (ESCC). There is no formal hypothesis testing in this study.

Timeline

Start
2021-08-18
Primary completion
2027-03-22
Completion
2027-03-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Belzutifan Small molecule 120 mg Oral
Subject Lenvatinib Small molecule 8 mg Oral
Subject Lenvatinib Small molecule 12 mg Oral
Subject Lenvatinib Small molecule 20 mg Oral
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous

Indications