NCT04976634

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

An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Multiple Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 730 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Effective as of Amendment 3 (26 Mar 2025), enrollment of participants with ESCC will be closed.

Conditions

• Neoplasm Malignant

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab 400 mg administered Q6W via IV infusion
DRUG	Belzutifan	Belzutifan 120 mg administered QD via oral tablet
DRUG	Lenvatinib	Lenvantinib dose for HCC is 8 mg QD for body weight \<60 kg and 12 mg QD for body weight ≥ 60 kg administered via oral capsule. For all other tumors, the lenvatinib dose is 20 mg QD administered via oral capsule

Timeline

• Start date: 2021-08-18
• Primary completion: 2027-03-22
• Completion: 2027-03-22
• First posted: 2021-07-26
• Last updated: 2025-04-06

Locations

57 sites across 10 countries: United States, Australia, Belgium, Chile, France, Israel, Netherlands, New Zealand, South Korea, Spain

Regulatory

• FDA-regulated drug study