CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 511 enrolled
Drug / intervention
Lenvatinib +2 moredrug
Likely dose
Lenvatinib 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04199104
NCT04199104Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010).

Merck Sharp & Dohme LLC·interventional·Posted Dec 13, 2019·Updated May 5, 2026

In Brief

A Phase 3 clinical trial evaluating Lenvatinib, Pembrolizumab, and 1 other intervention for Head and Neck Squamous Cell Carcinoma. Completed, enrolled 511 participants across 152 sites in 19 countries.

Detailed Summary

This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma. Hypotheses include: * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR. * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Squamous Cell Carcinoma
CountriesAustralia, Brazil, Canada, China, France, Germany, Hungary, Italy, Japan, Mexico, Peru, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
CollaboratorsEisai Inc.

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedDec 13, 2019
Enrollment StartFeb 5, 2020
Primary CompletionMay 30, 2023
Study CompletionMar 31, 2025
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 6.6 years ago

Interventions

Lenvatinibdrug

Lenvatinib, 20 mg (two 10-mg oral capsules) administered QD

Pembrolizumabbiological

Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W) by intravenous (IV) infusion for up to 35 3-week cycles

Placebodrug

Lenvatinib-matching placebo, oral capsules, administered once daily (QD)