Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61)

Official Title

A Phase 2, Single-arm, Open-label Clinical Trial of Pembrolizumab Plus Lenvatinib in Participants With First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (nccRCC) (KEYNOTE-B61)


This study is being performed as a single-arm open-label study in order to rapidly provide information on the potential benefits of the combination of pembrolizumab and lenvatinib in participants with previously untreated advanced/metastatic non-clear cell renal cell carcinoma.

Trial Description

Primary Outcome:

  • Objective Response Rate (ORR)
Secondary Outcome:
  • Duration of Response (DOR)
  • Progression-free Survival (PFS)
  • Overall Survival (OS)
  • Clinical Benefit Ratio (CBR)
  • Disease Control Rate (DCR)
  • Number of Participants Who Experienced One or More Adverse Events (AEs)
  • Number of Participants Who Discontinued Study Medication Due to an AE

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society