Urinary Bladder Neoplasms
Conditions
Interventions
Cetrelimab:Biological:TAR-200 + Cetrelimab:Participants will receive Cetrelimab.
TAR-200:Drug:TAR-200 + Cetrelimab:Participants will receive intravesical TAR-200.
Cisplatin:Drug:Chemotherapy (cisplati
Sponsors
Kitani Sumiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 ()1.5*ULN(except participants with Gilbert's syndrome, who must have a total bilirubin 30 mL/min using the Cockcroft-Gault formula.
Exclusion criteria
Exclusion criteria: 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 nephroureterectomy 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from Randomization to the First Bladder Intact Event-free Survival (BI-EFS) event Up to 8 years Time from randomization to the first BI-EFS event includes histologically proven presence of muscle-invasive bladder cancer (MIBC), clinical evidence of nodal or metastatic disease (as assessed by RECIST 1.1 criteria), radical cystectomy (RC), or death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Metastasis-free survival (MFS):Up to 8 years:MFS is measured from time from randomization to first radiologic (as assessed by RECIST 1.1 criteria) or histologic evidence of metastatic disease or death due to any cause. -Overall Survival (OS):Up to 8 years:OS is defined as time from randomization to death. -Overall Response Rate (ORR):Up to 8 years:ORR is defined as proportion of participants who have complete response (CR) (defined as Negative biopsy, and Computed tomography/Magnetic resonance imaging [CT/MRI] of chest, abdomen, and pelvis showing no evidence of local recurrence, progression, or metastatic disease) or partial response (PR): (defined as down staging: biopsy proven non-muscle invasive disease less than [<] T1 and CT/MRI of chest, abdomen, and pelvis showing no evidence of metastatic disease) or non-response (those not achieving a complete response or down-staging, or those who do not undergo a biopsy will be considered non-responders). -Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE):Up to 8 years:Number of Participants with AEs by Severity as assessed by CTCAE version 5 will be reported. Grade refers to the severity of the AE as follows: Grade 1- Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2- Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3- Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care ADL; Grade 4- Life-threatening consequences, urgent intervention indicated; Grade 5- Death related to AE. -Number of Participants with AEs by Severity according to Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE):Up to 8 years:NCI PRO-CTCAE is a patient-reported item lib | — |
Countries
Argentina, Australia, Austria, Brazil, Canada, Czechia, France, Germany, Greece, Hungary, India, Italy, Japan, Korea Republic Of, Mexico, Poland, Portugal, Russian Federation, Spain, Taiwan Province Of China, Turkey, Ukraine, United States of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed