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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)

Testing TAR-200 with or without Cetrelimab vs. BCG for bladder cancer.

Recruiting
18 years and older
All
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is about finding the best treatment for a type of bladder cancer called **high-risk non-muscle invasive bladder cancer (HR-NMIBC)**. The study is comparing two treatments: one using **TAR-200**, which is a special device that delivers a cancer medicine called **gemcitabine** into the bladder, and sometimes combined with a medicine called **cetrelimab**; the other treatment is a standard one called **BCG** therapy. **BCG** stands for **Bacillus Calmette-Guerin**, a type of bacteria used to treat bladder cancer.

Participants must have bladder cancer but not have received BCG treatment before. They should be ready to follow all study procedures. This study will last up to 5 years and 2 months, during which the safety and effectiveness of the treatments will be carefully checked.

  • Study will last up to 5 years and 2 months.
  • Participants must not have had BCG treatment before.
  • All study procedures must be followed by participants.
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Study details
    Bladder Cancer

NCT05714202

Janssen Research & Development, LLC

13 December 2024

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