Clinical Trial

A Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line Therapy

Study acronym: RESCUE

Withdrawn Phase 3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 single-arm trial designed to evaluate the safety and efficacy of NDV-01 (sustained-release gemcitabine-docetaxel) in adult participants with NMIBC with CIS who have failed BCG therapy and who have failed first-line therapy for BCG-unresponsive NMIBC (approved or in development) and are recommended for radical cystectomy.

Protocol Amendment History 1 amendment

This ClinicalTrials.gov record has been amended once since 2026-01-13.

Status change: Not Yet Recruiting → Withdrawn 2026-03-15

Trial Details

NCT Number	NCT07342517
Lead Sponsor	Relmada Therapeutics, Inc.
Conditions	Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent, Urologic Cancer
Start Date	2026-06-30
Primary Completion	2027-06-30 (estimated)
Study Completion	2028-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-03-17