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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).

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Trial Profile

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).

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Apr 2025

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At a glance

  • Drugs Lenvatinib (Primary) ; Pembrolizumab (Primary)
  • Indications Carcinoma; Head and neck cancer; Hypopharyngeal cancer; Laryngeal cancer; Mouth neoplasm; Oropharyngeal cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms China Extension Study; LEAP-010; MK-7902-010
  • Sponsors Merck Sharp & Dohme Corp.

Most Recent Events

  • 18 Apr 2025 Status changed from active, no longer recruiting to completed.
  • 25 Mar 2025 Planned End Date changed from 1 Mar 2025 to 31 Mar 2025.
  • 16 Apr 2024 Planned End Date changed from 29 Jul 2026 to 1 Mar 2025.

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