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RecruitingLast updated: 15 August 2023

LEAP-009: This phase II trial will test the safety and effectiveness of a targeted cancer drug, alone and in combination with immunotherapy, to see if it is better than standard of care chemotherapy in patients with head and neck cancers that have spread, come back and/or gotten worse after treatmentA 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)

Clinical summary

Summary

Pembrolizumab + Lenvatinib : Participants will be treated with the combination of pembrolizumab (200 mg 30-minute intravenous (IV) infusion on day 1 of each 21-day cycle for 35 cycles), plus lenvatinib (once daily 20 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met. Participants may receive up to an additional 17 cycles of pembrolizumab as Second Course treatment, with or without lenvatinib. Drug: Pembrolizumab : 200 mg 30-minute IV infusion on day 1 of each 21-day cycle

Conditions

This trial is treating patients with squamous cell carcinoma of the head and neck.

Cancer

Head and Neck Cancers Head and Neck

Age

People18+

Phase

II

Trial Acronym

LEAP-009

More information

Trial Identifiers

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Commercial Sponsor

Merck

Scientific Title

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)

Eligibility

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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