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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)

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Trial Profile

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: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 04 Jul 2025

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At a glance

  • Drugs Lenvatinib (Primary) ; Pembrolizumab (Primary) ; Capecitabine; Cetuximab; Docetaxel; Paclitaxel
  • Indications Head and neck cancer; Hypopharyngeal cancer; Laryngeal cancer; Mouth neoplasm; Oropharyngeal cancer; Squamous cell cancer
  • Focus Therapeutic Use
  • Acronyms MK-7902-009/E7080-G000-228/LEAP-009
  • Sponsors Merck Sharp & Dohme Corp.

Most Recent Events

  • 18 Nov 2024 Planned End Date changed from 17 Feb 2027 to 22 Dec 2025.
  • 21 Aug 2024 Status changed from recruiting to active, no longer recruiting.
  • 05 Aug 2024 Planned primary completion date changed from 18 Jul 2025 to 5 Sep 2025.

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