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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

NCT07342517 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2026-03-17

No results posted yet for this 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.

Conditions

  • Bladder (Urothelial, Transitional Cell) Cancer
  • Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)
  • Urothelial Carcinoma Bladder
  • Urothelial Carcinoma Recurrent
  • Urologic Cancer

Interventions

DRUG

NDV-01 (sustained-release gemcitabine-docetaxel)

Intravesical instillation of NDV-01 (sustained-release gemcitabine-docetaxel)

Sponsors & Collaborators

  • Relmada Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-06-30
Completion
2028-06-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07342517 on ClinicalTrials.gov