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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)

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Trial Profile

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)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 28 May 2025

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At a glance

  • Drugs Lenvatinib (Primary) ; Pembrolizumab (Primary)
  • Indications Bladder cancer; Carcinoma; Pelvic cancer; Renal cancer; Ureteral neoplasms; Urethral cancer; Urogenital cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms LEAP-011; MK-7902-011/E7080-G000-317/ LEAP-011
  • Sponsors Merck Sharp & Dohme; Merck Sharp & Dohme Corp.

Most Recent Events

  • 19 Sep 2024 This trial has been completed in Spain (Global end date: 2024-05-20) according to European Clinical Trials Database record.
  • 15 Aug 2024 This trial has been completed in Hungary, according to the European Clinical Trials Database record.
  • 01 Mar 2024 Status changed from active, no longer recruiting to discontinued.

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