Status:
ACTIVE_NOT_RECRUITING
A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Urinary Bladder Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone.
Detailed Description
Bladder cancer is the tenth most common malignancy worldwide. Approximately 25 percent (%) of all new bladder cancer participants present with muscle invasive bladder cancer (MIBC) at the time of diag...
Eligibility Criteria
Inclusion
- 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 \>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
- 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
Key Trial Info
Start Date :
July 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2027
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT04919512
Start Date
July 7 2022
End Date
March 7 2027
Last Update
December 19 2025
Active Locations (109)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Urological Associates of Southern Arizona, P.C.
Tucson, Arizona, United States, 85741
3
UAMS Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, United States, 72205
4
Arkansas Urology
Little Rock, Arkansas, United States, 72211