Clinical Trial

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

Study acronym: BOOST

Withdrawn Phase 3

View on ClinicalTrials.gov →

Why the trial stopped

This study has been incorporated into the Relmada REL-NDV01-303 study.

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.

Protocol Amendment History 1 amendment

This ClinicalTrials.gov record has been amended once since 2025-12-30.

Status change: Not Yet Recruiting → Withdrawn 2026-03-15

Trial Details

NCT Number	NCT07313891
Lead Sponsor	Relmada Therapeutics, Inc.
Conditions	Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Bladder (Urothelial, Transitional Cell) Cancer, Urothelial Carcinoma Bladder, Urologic Cancer
Start Date	2026-05-01
Primary Completion	2029-09-01 (estimated)
Study Completion	2029-11-01 (estimated)
Updated on ClinicalTrials.gov	2026-03-17