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

Part of paid clinical trials in Duarte, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT04740307
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 16, 2021
Status verified
May 2026
Primary completion
Jul 29, 2025
Completion
Jul 29, 2025

Study Design

Enrollment
116 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab/Quavonlimab + Lenvatinib
    Participants receive pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years, plus lenvatinib orally (based on actual body weight at screening) until progressive disease or unacceptable toxicity for up to 5 years. In the event of discontinuation of pembrolizumab/quavonlimab due to intolerable toxicity, re-initiation of treatment with pembrolizumab may be considered.

Primary Outcome Measure

Number of Participants With a Dose-Limiting Toxicity (DLT) in the Safety Lead-in Phase [ Time Frame: 3 weeks ]

Locations (7)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer Center ( Site 0002)DuarteCalifornia91010-
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - GI and Immunology ( Site 0013)BaltimoreMaryland21287-
Icahn School of Medicine at Mount Sinai ( Site 0009)New YorkNew York10029-
Oregon Health and Science University ( Site 0006)PortlandOregon97239-
Charleston Oncology ( Site 0003)CharlestonSouth Carolina29414-
Blue Ridge Cancer Care ( Site 0008)RoanokeVirginia24014-
Virginia Mason Medical Center ( Site 0004)SeattleWashington98101-

Related coverage on Hipa.ai

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CAJohns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - GI and Immunology· Baltimore, MDIcahn School of Medicine at Mount Sinai· New York, NYOregon Health and Science University· Portland, ORCharleston Oncology· Charleston, SCBlue Ridge Cancer Care· Roanoke, VA

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