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:
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
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 The pembrolizumab+lenvatinib and the pembrolizumab+placebo arms are no longer active for this study.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.