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Clinical Trial Active — Not Recruiting Phase II NCT04640623

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

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…

📅 29 Jul 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase II
NCT ID
NCT04640623
Start
2020-12-18
Completion
2025-07-03
ClinicaliQ Trial Snapshot
  • 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 — Active Not Recruiting •….
  • Trial testing TAR-200 drug alone or combined with cetrelimab immunotherapy versus cetrelimab alone for bladder cancer resistant to standard treatment.

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What This Trial Is Studying

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). Conditions: Urinary Bladder Neoplasms Interventions: TAR-200, Cetrelimab Lead Sponsor: Janssen Research & Development, LLC Planned Enrollment: 220 participants

Full Trial Details
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Eligibility criteria, protocol, and results when available
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