NCT04658862

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

A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 518 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Bladder Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	Cetrelimab	Participants will receive intravenous Cetrelimab.
DRUG	TAR-200	Participants will receive intravesical TAR-200.
DRUG	Cisplatin	Participants will receive cisplatin intravenously.
DRUG	Gemcitabine	Participants will receive gemcitabine intravenously.
RADIATION	Conventional radiation therapy	Participants will receive conventional radiation therapy for bladder (64 gy).
RADIATION	Hypo-fractioned radiation therapy	Participants will receive hypo-fractioned radiation therapy for bladder (55 gy).

Timeline

• Start date: 2020-12-07
• Primary completion: 2026-12-30
• Completion: 2028-12-31
• First posted: 2020-12-09
• Last updated: 2026-04-13

Locations

290 sites across 25 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Hungary, India, Italy, Japan, Mexico, Poland, Portugal, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study