A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder

Active:	Yes
Cancer Type:	Bladder Cancer Unknown Primary	NCT ID:	NCT04658862
Trial Phases:	Phase III	Protocol IDs:	CR108917 (primary) NCI-2021-10015 17000139BLC3001 2020-002620-36
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Janssen Research & Development, LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT04658862

Summary

The purpose of study is to compare bladder intact-event free survival (BI-EFS) in
participants receiving TAR-200 in combination with intravenous (IV) cetrelimab versus
concurrent chemoradiotherapy.

Objectives

The TAR-200 is an investigational intravesical drug delivery system. Cetrelimab
(JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that
binds programmed cell death protein 1 (PD-1). Study consists of screening phase of 42 days,
treatment phase and follow up phase. The total duration of study will be up to 8 years.
Efficacy evaluation includes disease assessment (Cystoscopy/TURBT Biopsy/Pathology) and
Patient Reported Outcomes (Quality of Life Assessments) and safety assessments includes vital
sign measurements, 12-lead electrocardiogram (ECG), physical examinations, clinical
laboratory tests, cystoscopic examination, anti-drug antibody (ADA) assessments, concomitant
treatments/procedures and adverse event monitoring.

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