NCT04640623

A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).

Conditions

• Urinary Bladder Neoplasms

Interventions

Type	Name	Description
DRUG	TAR-200	TAR-200 will be administered transuretherally.
BIOLOGICAL	Cetrelimab	Cetrelimab will be administered.

Timeline

• Start date: 2020-12-18
• Primary completion: 2025-07-03
• Completion: 2027-09-30
• First posted: 2020-11-23
• Last updated: 2026-04-13

Locations

144 sites across 16 countries: United States, Australia, Belgium, Canada, France, Germany, Greece, Italy, Japan, Netherlands, Portugal, Russia, South Korea, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study