At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab/Quavonlimab, Lenvatinib, and 1 other intervention for Advanced Hepatocellular Carcinoma. Completed, enrolled 116 participants across 40 sites in 9 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
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.
Interventions
Pembrolizumab/Quavonlimab (400 mg/25 mg) administered via IV infusion Q6W.
Lenvatinib 12 mg (body weight \[BW\] ≥60 kg) or 8 mg (BW \<60 kg) administered orally every day (QD).
Pembrolizumab (400 mg) administered via IV infusion Q6W, in the event of intolerable toxicity to pembrolizumab/quavonlimab.