Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04640623 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial
NCT04640623 · ClinicalTrials.gov record · last posted 2026-07-31

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

Study acronym: SunRISe-1
StatusActive, Not Recruiting
PhasePhase 2
Started2020-12-18
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).

Protocol amendment history 1 change detected by DataLookout

2026-07-30
Primary endpoint(s) modified
WasCohort 1, 2, and 3: Overall Complete Response (CR) Rate, Cohort 4: Disease-free Survival (DFS)
NowCohort 4: Disease-free Survival (DFS), Cohorts 1, 2, and 3: Overall Complete Response (CR) Rate
Trial Details
NCT Number NCT04640623
Lead Sponsor Janssen Research & Development, LLC
Conditions Urinary Bladder Neoplasms
Enrollment 220 participants
Start Date 2020-12-18
Primary Completion 2025-07-03 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-31