Clinical trial · no report yet · Phase 2
SunRISe-1
A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
- NCT04640623 ↗
- Active not recruiting
- Janssen Research & Development, LLC
- Focused
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| X threads | 3 |
The trial
ClinicalTrials.gov- Official title
- Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
- Phase
- Phase 2
- Status
- Active not recruiting
- Conditions
- Urinary Bladder Neoplasms
- Interventions
- TAR-200; Cetrelimab
- Arms
- Cohort 1: TAR-200 and Cetrelimab · Experimental
- Cohort 2: TAR-200 · Experimental
- Cohort 3: Cetrelimab · Experimental
- Cohort 4: TAR-200 (Participants with Papillary Disease only) · Experimental
- Enrollment
- 220
- Primary outcomes
- Cohorts 1, 2, and 3: Overall Complete Response (CR) Rate
- Cohort 4: Disease-free Survival (DFS)
- Sponsor
- Janssen Research & Development, LLC
- Start
- Dec 18, 2020
- Primary completion
- Jul 3, 2025
- Results posted
- Yes
- Registry record
- NCT04640623 · updated Sep 25, 2026
Publications
linked from the registry- Daneshmand S, Van der Heijden MS, Jacob JM, Guerrero-Ramos F, Bogemann M, Simone G, Pieczonka CM, Casco NC, Zainfeld D, Spiegelhalder P, Xylinas E, Cahn D, Lotan Y, Murray KS, Kawahara T, Stromberg K, Martin J, Shukla A, Cutie CJ, Bertzos K, Hampras S, Sweiti H, Necchi A; SunRISe-1 Study. TAR-200 for Bacillus Calmette-Guerin-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer: Results From the Phase IIb SunRISe-1 Study. J Clin Oncol. 2025 Nov 20;43(33):3578-3588. doi: 10.1200/JCO-25-01651. Epub 2025 Jul 30. PubMed 40737582