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Trial 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.



ACTRN/NCT /ethics:


Scientific title:

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).

Sponsor / Cooperative group:

Merck Sharp & Dohme Corp.

Trial & Patient Characteristics

Cancer TypeHead and Neck
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
Tumour Stream -
Cancer StageMetastatic or Widespread, Locally Recurrent or Locally Advanced
Anticipated Start Date2020-02-05
Anticipated End Date2024-04-24

Participating Hospitals

HospitalRoyal Adelaide Hospital
Clinical Trial CoordinatorAnne Milton
Phone08 7074 2342
Principal InvestigatorDr Anne Taylor
Recruitment StatusRecruiting