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Clinical trial · no report yet · Phase 2

SunRISe-4

A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder

  • NCT04919512 ↗
  • Completed
  • Janssen Research & Development, LLC
  • 118 commentary sources found
  • Deep

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.

Commentary we found

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

ChannelFound
YouTube49
X threads45
Podcasts24

The trial

ClinicalTrials.gov
Official title
A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy
Phase
Phase 2
Status
Completed
Conditions
Urinary Bladder Neoplasms
Interventions
TAR-200; Cetrelimab
Arms
  • Cohort 1: TAR-200 + Cetrelimab · Experimental
  • Cohort 2: Cetrelimab · Experimental
Enrollment
163
Primary outcomes
  • Pathologic Complete Response (pCR) Rate
Sponsor
Janssen Research & Development, LLC
Start
Jul 7, 2022
Primary completion
Feb 4, 2025
Results posted
Yes
Registry record
NCT04919512 · updated Jun 23, 2026

Publications

linked from the registry
  • Necchi A, Guerrero-Ramos F, Crispen PL, Herrera-Imbroda B, Garje R, Szabados B, Peyton CC, Pradere B, Ku JH, Shore N, Bogemann M, Preston MA, Xylinas E, Sanchez de Llano C, Gong C, Hasan M, Urtishak K, Battaglia S, Stitou H, Bhanvadia S, Sweiti H, Psutka SP. Gemcitabine Intravesical System Plus Cetrelimab or Cetrelimab Alone as Neoadjuvant Therapy in Muscle-Invasive Bladder Cancer: SunRISe-4 Primary Analysis and Biomarker Results. J Clin Oncol. 2026 Mar;44(7):586-597. doi: 10.1200/JCO-25-02382. Epub 2025 Dec 3. PubMed 41337691
  • Necchi A, Guerrero-Ramos F, Crispen PL, Herrera-Imbroda B, Garje R, Powles T, Peyton CC, Pradere B, Ku JH, Shore N, Bogemann M, Preston MA, Xylinas E, Sanchez de Llano C, Hasan M, Stitou H, Bhanvadia S, Sweiti H, Psutka SP. TAR-200 plus cetrelimab versus cetrelimab monotherapy as neoadjuvant therapy in patients with muscle-invasive bladder cancer who are ineligible for or decline neoadjuvant cisplatin-based chemotherapy (SunRISe-4): interim analysis of a randomised, open-label phase 2 trial. Lancet Oncol. 2025 Oct;26(10):1312-1322. doi: 10.1016/S1470-2045(25)00358-4. Epub 2025 Aug 27. PubMed 40885199