# A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)

Source: https://onco.cc/trials/hr-nmibc/  
OnCo record `hr-nmibc` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing Cetrelimab in bladder & urothelial cancer, active and no longer recruiting.

## Summary

A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC) is a phase 3 interventional study registered as NCT05714202, led by Janssen Research & Development, and active but no longer recruiting on the registry. Official title: A Phase 3, Open-Label, Multi-Center, Randomised Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer. Planned enrolment is 1135 participants (actual). The study started in 2023-03-23 and primary completion is expected in 2029-09-18. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-11
- Also known as: SunRISe-3
- Tags: ctgov-ingest
- Registry id: NCT05714202
- Phase: 3
- Setting: A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer
- Sponsor: Janssen Research & Development
- Enrolled: 1135

## Sources

- ClinicalTrials.gov NCT05714202: https://clinicaltrials.gov/study/NCT05714202

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Non-muscle-invasive bladder cancer](https://onco.cc/cancers/non-muscle-invasive-bladder-cancer/)
- drugs: [Cetrelimab](https://onco.cc/drugs/cetrelimab/)
- companies: [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/)

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