Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011)

  • STATUS
    Recruiting
  • End date
    Oct 31, 2023
  • participants needed
    694
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 22 September 2021
radical cystectomy
cancer
hearing loss
metastasis
carboplatin
pembrolizumab
neuropathy
solid tumour
bladder cancer
invasive bladder cancer
platinum-based chemotherapy
metastatic urothelial carcinoma

Summary

The purpose of this study is to evaluate the efficacy and safety of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in the treatment of cisplatin-ineligible participants with a Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) 10, or in participants ineligible for any platinum-containing chemotherapy regardless of CPS, with advanced/unresectable or metastatic urothelial carcinoma (UC).

The primary hypotheses for this study are that:

  1. Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR), and
  2. Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Overall Survival (OS).

Details
Condition Transitional cell carcinoma, Urothelial Carcinoma
Treatment Pembrolizumab, Lenvatinib, Placebo for lenvatinib
Clinical Study IdentifierNCT03898180
SponsorMerck Sharp & Dohme Corp.
Last Modified on22 September 2021

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