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Clinical trial

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)

NCT03898180 is registered in ClinicalTrials.gov with Merck Sharp & Dohme LLC as lead sponsor.

NCT NCT03898180
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Registry record

As filed in ClinicalTrials.gov.

Title
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)
Lead sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Overall status
Completed
Start date
May 6, 2019
Completion date
May 20, 2024
Enrollment
505 (actual)
Sites
194

Conditions

As the registry lists them; a condition with its own page is linked.

urothelial carcinoma