A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder
Bladder Cancer
Unknown Primary
18 Years and older, Male and Female
CR108917 (primary)
NCI-2021-10015
17000139BLC3001
2020-002620-36
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
- 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 (<) 2 prior to randomization
- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
- Thyroid function tests within normal range or stable on hormone supplementation per investigator assessment.
- 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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