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

NCT07313891 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL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, 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.

Conditions

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

Principal Investigators

  • Raj S Pruthi, MD MHA · Relmada Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2029-09-01
Completion
2029-11-01
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 NCT07313891 on ClinicalTrials.gov