A Phase 3 Randomized Double-blind Study to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Lenvatinib (E7080/MK-7902) Versus Pembrolizumab and Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin-ineligible Participants Whose Tumors Express PD-L1 and in Participants Ineligible for Any Platinum-containing Chemotherapy Regardless of PD-L1 Expression (LEAP-011)

Brief description of study

This is a randomized, placebo-controlled, parallel-group, multi-site, double-blind study of pembrolizumab + lenvatinib in cisplatin-ineligible participants whose tumors express PD-L1 (CPS =10), and in participants ineligible for any platinum-containing chemotherapy, with advanced/unresectable or metastatic UC. This Phase 3 study will be conducted in participants with measurable disease who provide tumor tissue (newly obtained or archival formalin-fixed paraffin-embedded [FFPE] tumor biopsy) for determination of PD-L1 expression, as assessed with the diagnostic IHC 22C3 pharmDx at the central laboratory.


Clinical Study Identifier: s18-01918
ClinicalTrials.gov Identifier: NCT03898180
Principal Investigator: Arjun Vasant Balar.


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