Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) for Advanced Melanoma in Anti-Programmed Death-1/Programmed Death-Ligand 1 (PD-1/L1)-Exposed Participants (MK-7902-004/E7080-G000-225/LEAP-004)

Official Title

A Multicentre, Open-label, Phase 2 Trial to Assess the Efficacy and Safety of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Melanoma Previously Exposed to an Anti-PD-1/L1 Agent (LEAP-004)

Summary:

This study will evaluate the safety and efficacy of combination therapy of lenvatinib (E7080/MK-7902) and pembrolizumab following approximately 2 years of pembrolizumab therapy and approximately 2 years or more lenvatinib therapy in adult participants with unresectable or advanced melanoma who have been exposed to anti-PD-1/L1 agents approved for unresectable or metastatic melanoma. No statistical hypothesis will be tested in this study.

Trial Description

Primary Outcome:

  • Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST 1.1)
Secondary Outcome:
  • Progression-free Survival (PFS) per Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST 1.1)
  • Overall Survival (OS)
  • Duration of Response (DOR) per Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST 1.1)
  • Percentage of Participants Who Experience At Least One Adverse Event (AE)
  • Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
  • Area Under the Concentration Time Curve of Lenvatinib From Time 0 to Infinity (AUC 0-inf)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society