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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

Status
Active
Cancer Type
Bladder Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04658862
Protocol IDs
CR108917 (primary)
NCI-2021-10015
17000139BLC3001
2020-002620-36
Study Sponsor
Janssen Research & Development, LLC

Summary

The purpose of study is to compare bladder intact-event free survival (BI-EFS) in
participants receiving TAR-200 in combination with cetrelimab versus concurrent
chemoradiotherapy.

Objectives

The TAR-200 is an investigational drug delivery system. Cetrelimab (JNJ-63723283) is a fully
human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed cell
death protein 1 (PD-1). Study consists of screening phase of 42 days, treatment phase and
follow up phase. The total duration of study will be up to 8 years. Efficacy evaluation
includes disease assessment (Cystoscopy/TURBT Biopsy/Pathology) and Patient Reported Outcomes
(Quality of Life Assessments) and safety assessments includes vital sign measurements,
12-lead electrocardiogram (ECG), physical examinations, clinical laboratory tests,
cystoscopic examination, anti-drug antibody (ADA) assessments, concomitant
treatments/procedures and adverse event monitoring.

Eligibility

  1. Ineligible for or have elected not to undergo radical cystectomy
  2. 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 (<) 2 prior to randomization
  3. Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
  4. Thyroid function tests within normal range or stable on hormone supplementation per investigator assessment.
  5. Adequate bone marrow, liver, and renal function: Bone marrow function (without the support of cytokines or erythropoiesis-stimulating agent in preceding two weeks): Absolute neutrophil count (ANC) greater than or equal to (>=) 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 (<=) 1.5 * upper limit of normal (ULN) or direct bilirubin <= ULN for participants with total bilirubin levels greater than (>)1.5*ULN (except participants with Gilbert's Syndrome, who must have a total bilirubin < 3.0 mg/dL), and Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to (<=) 2.5* institutional ULN); Renal function: Creatinine clearance >40 mL/min using the Cockcroft-Gault formula
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