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

NCT04658862 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 518

Last updated 2026-05-08

No results posted yet for this study

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

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).

BIOLOGICAL

Cetrelimab

Participants will receive intravenous Cetrelimab.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trials · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-07
Primary Completion
2026-12-30
Completion
2028-12-31
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04658862 on ClinicalTrials.gov