Study # SunRISe-3

A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and
Safety 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

Study Status:

Enrolling

Treatment Agent:

TAR-200, Cetrelimab, BCG Vesiculture

Description

Short Title: SunRISe-3

Bladder cancer is the tenth most common malignancy worldwide. About 75 percent (%) of bladder cancers are non-muscle invasive at diagnosis with approximately 25% of NMIBC patients have HR, NMIBC. The TAR-200/gemcitabine (JNJ-17000139) product is an intravesical drug delivery system regulated as an investigational drug. The drug constituent consists of gemcitabine and osmotic minitablets. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed-cell death protein (PD)-1. The mainstay of treatment for HR-NMIBC is transurethral resection of bladder tumor, followed by intravesical treatment with BCG. In this study metronomic dosing of intravesical gemcitabine, delivered via TAR-200, alone or in combination with cetrelimab will be evaluated and compared against intravesical BCG.

Resources and Links

National Clinical Trial Identified Number: NCT05714202

Information and next steps

Disease:

  • Bladder Cancer,
  • BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)

Study Phase:

III

Physician Name:

Department:

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