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Active Not Recruiting
NCT04658862
A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder
Conditions: Urinary Bladder Neoplasms
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 518
Sponsor: Janssen Research & Development, LLC
Location: Loma Linda Univ Faculty Medic Loma Linda California
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.
Eligibility Criteria
Inclusion Criteria:
* Ineligible for or have elected not to undergo radical cystectomy
* All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade less than (\=) 1,500/cubic millimeters (mm\^3); Platelet count \>=80,000/mm\^3; Hemoglobin \>=9.0 grams per deciliter (g/dL); Liver function: (Total bilirubin less than or equal to (\
Source: ClinicalTrials.gov (NCT04658862). StuddyBuddy aggregates publicly available trial information.
