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
- Conditions
- 10038364Bladder cancer
- Registration Number
- NL-OMON54183
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 8
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:
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>6. Primary study parameters/outcome of the study (in English):<br /><br>Outcome Measure: Percentage of Participants with Pathologic Complete Response<br /><br>(pCR)<br /><br>Time frame: Up to Week 15<br /><br>Description: Percentage of participants with a pathologic complete response<br /><br>(pCR) or no evidence of pathologic intravesical disease and nodal involvement<br /><br>(ypT0N0) derived from analysis of radical cystectomy (RC) bladder specimen will<br /><br>be reported.</p><br>
- Secondary Outcome Measures
Name Time Method