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 Chemothe

• Status: Active, not recruiting
• Trial end date: 2023-10-31

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).

With Amendment 3 study treatment with lenvatinib and placebo was discontinued and all participants were unblinded and continued treatment with pembrolizumab monotherapy only. The pembrolizumab+lenvatinib and the pembrolizumab+placebo arms are no longer active for this study.

With Amendment 3 the external Data Monitoring Committee was discontinued.

• Phase: Phase 3

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Eisai Inc.
• Treatments: Cisplatin; Lenvatinib; Pembrolizumab