Trial Profile

A Phase 2, Randomised, Multi-center, Open Label Trial to Evaluate the Safety and Efficacy of Intravesical Nadofaragene Firadenovec Alone or in Combination with Chemotherapy or Immunotherapy in Participants with High-grade Bacillus Calmette-Guerin Therapy (BCG) Unresponsive Non-muscle Invasive Bladder Cancer (NMIBC)

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 11 Jun 2025

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At a glance

Drugs Nadofaragene-firadenovec (Primary) ; Docetaxel; Gemcitabine; Pembrolizumab
Indications Bladder cancer
Focus Therapeutic Use
Acronyms ABLE-22

04 Jun 2025 Planned number of patients changed from 150 to 250.
23 Apr 2025 Planned End Date changed from 30 Jul 2028 to 31 Dec 2030
23 Apr 2025 Planned primary completion date changed from 30 Jul 2026 to 31 Dec 2030

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