Trials / Withdrawn

WithdrawnNCT07313891

A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Following TURBT

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Status: Withdrawn
Phase: Phase 3
Study type: Interventional
Enrollment: 0 (actual)

Sponsor: Relmada Therapeutics, Inc. · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This is a Phase 3, open-label, randomized trial designed to evaluate the DFS of TURBT followed by NDV-1 (sustained-release gemcitabine-docetaxel) versus TURBT followed by surveillance for the treatment of participants with IR-NMIBC.

Detailed description

Participants will be randomized 1:1 to NDV-1 (sustained-release gemcitabine-docetaxel) after TURBT (Arm A) vs surveillance after TURBT (Arm B). Participants in Arm A will receive an induction course and then monthly maintenance courses of NDV-1 (sustained-release gemcitabine-docetaxel) through Month 12, if there is no disease recurrence. Disease status will be assessed using urine cytology, cystoscopy, and directed TURBT/biopsy (if indicated) every 3 months for the first 2 years after randomization and then every 6 months for an additional year or until disease recurrence. Participants in Arm B who recur with IR-NMIBC after TURBT and surveillance will be offered treatment with NDV-1 (sustained-release gemcitabine-docetaxel) as per the treatment schedule in Arm A.

Conditions

Interventions

Type	Name	Description
DRUG	NDV-01 (sustained-release gemcitabine-docetaxel)	Intravesical instillation of NDV-01 (sustained-release gemcitabine-docetaxel)

Timeline

Start date: 2026-05-01
Primary completion: 2029-09-01
Completion: 2029-11-01
First posted: 2026-01-02
Last updated: 2026-03-17

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT07313891. Inclusion in this directory is not an endorsement.