A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder

Active:	Yes
Cancer Type:	Bladder Cancer Unknown Primary	NCT ID:	NCT04919512
Trial Phases:	Phase II	Protocol IDs:	CR109044 (primary) NCI-2022-05645 17000139BLC2002 2020-005565-13
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Janssen Research & Development, LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT04919512

Summary

The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination
with intravenous (IV) cetrelimab and IV cetrelimab alone.

Objectives

Bladder cancer is the tenth most common malignancy worldwide. Approximately 25 percent
(%) of all new bladder cancer participants present with muscle invasive bladder cancer
(MIBC) at the time of diagnosis, and roughly 50% will ultimately develop distant
metastases. The TAR-200/ gemcitabine (JNJ-17000139) product is an intravesical drug
delivery system regulated as an investigational drug. The drug constituent consists of
gemcitabine minitablets 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 standard of care in MIBC includes radical cystectomy (RC) with
urinary diversion and is considered the preferred treatment option for participants who
are considered surgical candidates. Study consists of a Screening phase, Treatment phase
and follow-up phase. The total duration of study will be up to 2 years and 6 months.
Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specific time
points during this study.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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