Suspended

SunRISe-5TAR-200 for High-Risk Non-Muscle-Invasive Bladder Cancer After BCG

Study Aim

This phase 3 study aims to evaluate the effectiveness of TAR-200 in extending disease-free survival for patients with high-risk non-muscle-invasive bladder cancer who have previously undergone treatment with Bacillus Calmette-Guérin.

What is being tested

TAR-200

+ Mitomycin C

+ Gemcitabine

Drug

Who is being recruted

Urogenital Diseases+12

+ Non-Muscle Invasive Bladder Neoplasms

+ Urinary Bladder Diseases

Over 18 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: April 2024

See protocol details

Summary

Principal SponsorJanssen Research & Development, LLC

Last updated: March 18, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 9, 2024

Actual date on which the first participant was enrolled.

The study aims to explore a new treatment option for individuals with a specific type of bladder cancer called high-risk non-muscle-invasive bladder cancer (HR-NMIBC). These individuals have experienced cancer recurrence after receiving a treatment known as Bacillus Calmette-Guérin (BCG). The study focuses on those who are either unable or choose not to undergo a major surgery called radical cystectomy. By comparing a new treatment, TAR-200, to traditional chemotherapy options, the study hopes to find a more effective way to prevent the cancer from coming back. Finding a better treatment could significantly improve the quality of life and health outcomes for those affected by this challenging cancer condition. Participants in the study will be assigned to receive either the TAR-200 treatment or a chemotherapy treatment chosen by the study doctor. TAR-200 is a form of treatment that stays in the bladder, releasing medication over time to target cancer cells. The study will evaluate how well each treatment keeps the cancer from returning, known as disease-free survival. By comparing these two approaches, the study aims to determine which is more successful in managing the cancer without requiring major surgery. This research is important as it may lead to more effective treatment options for individuals with this type of bladder cancer.

Official TitleA Phase 3, Randomized, Open-label, Multi-center Study Evaluating the Efficacy and Safety of TAR-200 Versus Investigator's Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High-risk Non-muscle-invasive Bladder Cancer (HR-NMIBC) and Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

NCT06211764

Principal SponsorJanssen Research & Development, LLC

Last updated: March 18, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

272 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesNon-Muscle Invasive Bladder NeoplasmsUrinary Bladder DiseasesUrinary Bladder NeoplasmsCarcinomaFemale Urogenital Diseases and Pregnancy ComplicationsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

4 inclusion criteria required to participate

Histologically confirmed diagnosis by local pathology (within 90 days of documented informed consent) of recurrent, papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) [defined as high-grade Ta or any T1, no carcinoma in situ (CIS)]

Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial (transitional cell histology) predominance. However, neuroendocrine, and small cell variants will be excluded

Participants must be ineligible for or have elected not to undergo Radical Cystectomy (RC)

Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2

5 exclusion criteria prevent from participating

Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, N+, and/or M+)

Presence of any bladder or urethral anatomic feature that, in the opinion of the Investigator, may prevent the safe placement, indwelling use, or removal of TAR-200. Participants with tumors involving the prostatic urethra in men will be excluded

A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters ( > 4000 mL)

Indwelling catheters are not permitted; however, intermittent catheterization is acceptable

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants will receive intravesical TAR-200 every 3 weeks during an induction phase and every 12 weeks during a maintenance phase.

Group II

Active Comparator

Participants will receive either single agent intravesical MMC or gemcitabine every week during an induction phase and every 4 weeks during a maintenance phase.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 123 locations

Suspended

Arkansas Urology

Little Rock, United StatesOpen Arkansas Urology in Google Maps

Suspended

Genesis Research LLC 1

Los Alamitos, United States

Suspended

USC Norris Comprehensive Cancer Center

Los Angeles, United States

Suspended

University of California Irvine Medical Center

Orange, United States

Suspended123 Study Centers