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A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)

NCT06211764 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2026-05-08

No results posted yet for this study

Summary

The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of single agent intravesical chemotherapy.

Conditions

  • Non-Muscle Invasive Bladder Neoplasms

Interventions

DRUG

TAR-200

Participants will receive TAR-200 intravesically.

DRUG

Mitomycin C

Participants will receive MMC intravesically.

DRUG

Gemcitabine

Participants will receive gemcitabine intravesically.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-09
Primary Completion
2030-11-27
Completion
2031-04-14
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • China
  • France
  • Germany
  • Italy
  • Japan
  • Poland
  • Romania
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT06211764 on ClinicalTrials.gov