Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 (<) 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

Exclusion Criteria

  • Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/T1/Carcinoma in situ (CIS) of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephrouretrectomy more than 24 months prior to initiating study - Must not have diffuse CIS based on cystoscopy and biopsy. Diffuse, or multi-focal, CIS is defined as the presence of at least 4 distinct CIS lesions in the bladder at the time of the Screening re-TURBT - Participants must not have evidence of cT4b, or N1-3, or M1 disease based on local radiology staging (chest, abdomen, and pelvis must be performed using Computed tomography [CT] or Magnetic resonance imaging [MRI]) within 42 days prior to randomization - Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR 200 - Evidence of bladder perforation during diagnostic cystoscopy

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TAR-200 + Cetrelimab
Participants will receive intravesical TAR-200 every 3 weeks (21 days indwelling) for first 18 weeks and thereafter from Week 24 every 12 weeks through study Year 3 in combination with Cetrelimab.
  • Biological: Cetrelimab
    Participants will receive intravenous Cetrelimab.
    Other names:
    • JNJ-63723283
  • Drug: TAR-200
    Participants will receive intravesical TAR-200.
    Other names:
    • JNJ-17000139
Active Comparator
Chemotherapy (cisplatin or gemcitabine) + Radiation Therapy
Participants will receive chemotherapy based on investigator's choice from either cisplatin intravenously once weekly for 6 treatment weeks or gemcitabine intravenously twice weekly for 6 treatment weeks as Standard of Care (SOC) along with radiation therapy from either conventional radiotherapy (64 Gray [Gy], bladder only) for up to 6.5 treatment weeks or hypo-fractionated radiotherapy (55 Gy, bladder only) for up to 4 weeks.
  • 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).

Recruiting Locations

University of Texas Medical Branch
League City, Texas 77573

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
JNJ.CT@sylogent.com

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.