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Clinical Trial Active — Not Recruiting Phase III NCT05714202

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)

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) — Active…

📅 05 Jun 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase III
NCT ID
NCT05714202
Start
2023-03-23
Completion
2029-09-18
ClinicaliQ Trial Snapshot
  • 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) — Active Not Recruiting • Phase III • Oncology • NCT05714202.
  • Trial comparing two new bladder cancer treatments (TAR-200 with or without cetrelimab) against standard BCG therapy in untreated high-risk patients.

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What This Trial Is Studying

The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B). Conditions: Bladder Cancer Interventions: TAR-200, Cetrelimab, BCG Vesiculture Lead Sponsor: Janssen Research & Development, LLC Planned Enrollment: 1135 participants

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