Bladder cancer
Conditions
Interventions
5. Intervention (if applicable) (in English):
Study Arms:
Cohort 1: TAR-200 + IV Cetrelimab (Participants will receive TAR-200 in
combination with IV cetrelimab.)
Cohort 2: IV Cetrelimab (Participan
Sponsors
Janssen-Cilag International NV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: - Histologically proven, cT2-T4a N0, M0 infiltrating urothelial carcinoma of the bladder. Initial diagnosis must have been within 120 days of randomization date. Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial predominance. However, the presence of small cell or neuroendocrine variants will make a participant ineligible - Participants with no residual tumor, or intravesical tumor size of less than or equal to <=3 centimeter (cm) following transurethral resection of bladder tumor (TURBT) are eligible; debulking TURBT for any residual disease is encouraged but not mandated. Participants with persistent tumors greater than (>)3 cm at screening must undergo a second debulking, re-staging TURBT. Participants will be ineligible if any individual tumor is greater than (>)3 cm after debulking TURBT - Deemed eligible for and willing to undergo RC by the operating urologist - Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or 1 - Thyroid function tests within normal range or stable on hormone supplementation per investigator assessment. Investigators may consult an endocrinologist for participant eligibility assessment in the case of equivocal or marginal tests results - All adverse events associated with any prior surgery must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (<) 2 prior to randomization
Exclusion criteria
Exclusion criteria: Exclusion Criteria: - Must not have received prior systemic chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to starting study treatment - Participants must not have evidence of cT4b, or N1-3, or M1 disease based on central 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 - Prior systemic chemotherapy for urothelial cell carcinoma of the bladder at any time - Currently participating or has participated in a study of an investigational agent and received study therapy or investigational device within 4 weeks prior to enrollment - Participants with evidence of bladder perforation during diagnostic cystoscopy. Participant is eligible if perforation has resolved prior to dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6. Primary study parameters/outcome of the study (in English): Outcome Measure: Percentage of Participants with Pathologic Complete Response (pCR) Time frame: Up to Week 15 Description: Percentage of participants with a pathologic complete response (pCR) or no evidence of pathologic intravesical disease and nodal involvement (ypT0N0) derived from analysis of radical cystectomy (RC) bladder specimen will be reported. | — |
Secondary
| Measure | Time frame |
|---|---|
| 7. Secondary study parameters/outcome of the study (if applicable) (in English): Outcome Measure: Recurrence-Free Survival (RFS) Time frame: Up to Week 108 Description: RFS is defined as the time from randomization to first radiologic (as assessed by response evaluation criteria in solid tumors [RECIST] 1.1 criteria) or histologic evidence of nodal or metastatic disease or death due to any cause. Outcome Measure: Number of Participants with Adverse Events (AEs) by Grades According to Common Terminology Criteria for Adverse Events (CTCAE) Time frame: Up to Week 108 Description: Number of participants with AEs by severity grade as assessed by CTCAE version 5 will be reported. Grade refers to the severity of AE as follows: Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5- Death related to adverse event. Outcome Measure: Number of Participants with Change from Baseline in Laboratory Abnormalities Time frame: Up to Week 108 Description: Number of participants with change from baseline in laboratory abnormalities will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event. | — |
Countries
Netherlands
Outcome results
None listed