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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: 06 Jan 2026

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At a glance

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

Most Recent Events

  • 02 Jan 2026 Status changed from planning to not yet recruiting.
  • 15 Dec 2025 New trial record
  • 13 Nov 2025 According to a Relmada Therapeutics media release, the company look forward to working with the FDA to establish the final study design and initiate the registrational program in the first half of 2026.

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