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A Phase 3, Randomized Study Evaluating the Efficacy and Safety of NDV-01 Versus Observation in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (BOOST)

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Trial Profile

A Phase 3, Randomized Study Evaluating the Efficacy and Safety of NDV-01 Versus Observation in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (BOOST)

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Jan 2026

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At a glance

  • Drugs Docetaxel/gemcitabine (Primary)
  • Indications Bladder cancer; Transitional cell carcinoma
  • Focus Registrational; Therapeutic Use
  • Acronyms BOOST
  • Sponsors Relmada Therapeutics

Most Recent Events

  • 12 Jan 2026 According to a Relmada Therapeutics media release, In its written response to Type B pre-IND submission,supportive written feedback on the Company's planned single registrational study in intermediate-risk NMIBC in the adjuvant setting, which is expected to follow an open-label, randomized-to-observation design.
  • 02 Jan 2026 Status changed from planning to not yet recruiting.
  • 15 Dec 2025 New trial record

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