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

NCT04740307 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2025-08-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2025-07-29
Completion
2025-07-29
FDA Drug
Yes

Countries

  • United States
  • China
  • Italy
  • Japan
  • Poland
  • South Korea
  • Spain
  • Switzerland
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04740307 on ClinicalTrials.gov