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A Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

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Trial Profile

A Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 30 Mar 2025

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At a glance

  • Drugs Pembrolizumab (Primary) ; Zelenectide pevedotin (Primary) ; Avelumab; Carboplatin; Cisplatin; Gemcitabine
  • Indications Bladder cancer; Pelvic cancer; Ureteral neoplasms; Urethral cancer; Urogenital cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms Duravelo-2
  • Sponsors Bicycle Therapeutics

    • Most Recent Events

    • 13 Jan 2025 According to Bicycle Therapeutics media release, Phase 2/3 Duravelo-2 Cohort 1 and Cohort 2 dose selection data expected in 2H 2025.
    • 12 Dec 2024 According to Bicycle Therapeutics media release, dose selection and topline data from Phase 2/3 Duravelo-2 trial planned for 2H 2025
    • 31 Oct 2024 According to Bicycle Therapeutics media release, additional data updates for zelenectide pevedotin monotherapy in other tumor types and in combination with pembrolizumab in first-line mUC are planned by year end.

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