A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination with Cetrelimab and Cetrelimab Alone in Participants with Muscle-Invasive Urothelial Carcinoma of the Bladder who are Scheduled for Radical Cystectomy and are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy
The primary objective is
To determine the anti-tumor effects, as assessed by pathologic complete response (pCR) at radical cystectomy (RC), of TAR-200 in combination with IV cetrelimab and IV cetrelimab alone.
Secondary objectives:
To evaluate the safety and recurrence-free survival (RFS) in participants receiving TAR-200 in combination with IV cetrelimab and IV cetrelimab alone.
TAR-200
Chemotherapy multiple agents systemic
- Rutgers Cancer Institute of New Jersey
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 >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
- 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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.