Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumours (MK-7902-005/E7080-G000-224/LEAP-005)

Official Title

A Multicentre, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumours (LEAP-005)

Summary:

The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), or biliary tract cancers (BTC). Participants will be enrolled into initial tumour-specific cohorts which will be expanded if adequate efficacy is determined.

Trial Description

Primary Outcome:

  • Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria for Glioblastoma (GBM) by Investigator Assessment in Initial Cohorts
  • ORR per RECIST 1.1 or RANO (GBM) by Blinded Independent Central Review (BICR) in Expanded Cohorts (Combined with Initial Cohorts)
  • Percentage of Participants who Experience an Adverse Event (AE)
  • Percentage of Participants who Discontinue Study Treatment Due to an Adverse Event (AE)
Secondary Outcome:
  • Disease Control Rate (DCR) per RECIST 1.1 by Investigator Assessment in Initial Cohorts
  • Duration of Response (DOR) per RECIST 1.1 or RANO (GBM) by Investigator Assessment in Initial Cohorts
  • Progression Free Survival (PFS) per RECIST 1.1 or RANO (GBM) by Investigator Assessment in Initial Cohorts
  • Overall Survival (OS) in Initial Cohorts
  • DCR per RECIST 1.1 by BICR in Expanded Cohorts (Combined with Initial Cohorts)
  • DOR per RECIST 1.1 or RANO (GBM) by BICR in Expanded Cohorts (Combined with Initial Cohorts)
  • PFS per RECIST 1.1 or RANO (GBM) by BICR in Expanded Cohorts (Combined with Initial Cohorts)
  • OS in Expanded Cohorts (Combined with Initial Cohorts)
  • Plasma Concentration of Lenvatinib

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