drugset
drugset / Trial / NCT04658862

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

NCT04658862 ↗

Phase 3 Active not recruiting 518 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-12-07
Primary completion
2026-12-30
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetrelimab Monoclonal antibody — Intravenous
Comparator Cisplatin Other / unclassified — Intravenous
Comparator Gemcitabine Small molecule — Intravenous
Subject TAR-200 Other / unclassified — Other

Indications

urinary bladder neoplasm