NCT04740307

Safety and Efficacy of Coformulated Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib (E7080/MK-7902) in Advanced Hepatocellular Carcinoma (MK-1308A-004)

A Phase 2, Multicenter, Clinical Study to Evaluate the Safety and Efficacy of MK-1308A (Coformulated MK-1308/MK-3475) in Combination With Lenvatinib (E7080/MK-7902) in First-line Therapy of Participants With Advanced Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• 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 and efficacy of fixed dose coformulated pembrolizumab/quavonlimab (MK-1308A) plus lenvatinib in a first line (1L) hepatocellular carcinoma (HCC) setting. No hypothesis testing will be performed.

Conditions

• Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab/Quavonlimab	Pembrolizumab/Quavonlimab (400 mg/25 mg) administered via IV infusion Q6W.
DRUG	Lenvatinib	Lenvatinib 12 mg (body weight \[BW\] ≥60 kg) or 8 mg (BW \<60 kg) administered orally every day (QD).
BIOLOGICAL	Pembrolizumab	Pembrolizumab (400 mg) administered via IV infusion Q6W, in the event of intolerable toxicity to pembrolizumab/quavonlimab.

Timeline

• Start date: 2021-03-16
• Primary completion: 2025-07-29
• Completion: 2025-07-29
• First posted: 2021-02-05
• Last updated: 2025-08-13

Locations

40 sites across 9 countries: United States, China, Italy, Japan, Poland, South Korea, Spain, Switzerland, Taiwan

Regulatory

• FDA-regulated drug study