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:	Yes
Cancer Type:	Bladder Cancer Unknown Primary	NCT ID:	NCT05714202
Trial Phases:	Phase III	Protocol IDs:	CR109223 (primary) NCI-2023-05193 17000139BLC3002 2020-004506-64
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Janssen Research & Development, LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT05714202

Summary

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).

Objectives

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.
The study consists of a Screening phase, Treatment phase, and Follow-up phase. The total
duration of the study will be up to 5 years and 2 months. Efficacy, Safety,
pharmacokinetics (PK), and biomarkers will be assessed at specific time points during the
study.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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