A Phase 2, randomized, open-label three-arm clinical study to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3475) versus standard of care chemotherapy and lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and immunotherapy (PD-1/PD-L1 inhibitors) (LEAP-009)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500820-31-00

Acronym

MK-7902-009

Enrollment

158

Registered

2024-04-29

Start date

2020-07-16

Completion date

2025-09-02

Last updated

2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent or metastatic squamous cell carcinoma of the head and neck

Brief summary

Overall Survival (OS)

Detailed description

Progression-Free Survival (PFS), Objective Response Rate (ORR), Duration of Response (DOR), Number of Participants Who Experienced One or More Adverse Events (AEs), Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)

Interventions

DRUGDOCETAXEL

DRUGPACLITAXEL

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGCAPECITABINE

DRUGCETUXIMAB

DRUGLenvatinib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS)	—

Secondary

Measure	Time frame
Progression-Free Survival (PFS), Objective Response Rate (ORR), Duration of Response (DOR), Number of Participants Who Experienced One or More Adverse Events (AEs), Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)	—

Countries

Denmark, France, Norway, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026