NCT05072600 Pembrolizumab Monotherapy Following Tri-modality Treatment for Selected Patients With Muscle-invasive Bladder Cancer
| NCT ID | NCT05072600 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking University First Hospital |
| Condition | Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2021-12-07 |
| Primary Completion | 2024-12-07 |
Trial Parameters
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Brief Summary
This is a Phase II, single-arm, study of pembrolizumab as maintenance therapy in muscle-invasive bladder cancer (MIBC) participants who have received maximum TURBT and tri-modality treatment (TMT) and achieved CR. All participants will receive pembrolizumab monotherapy per 21 days no longer than 17 cycles until disease progression or death.
Eligibility Criteria
Inclusion Criteria: 1. Male/female participants who are at least 18 years of age on the day of signing informed consent. 2. Based on AJCC 8th edition: stage cT2-4N0M0，Urothelial carcinoma \>50% and * Requires definitive local therapy * Has received maximum TURBT followed by tri-modality therapy * Achieved CR after tri-modality therapy, the acceptable duration of time between completion of TMT and assessment of CR was 28-90 days. 3. Tumor was located at one side of bladder wall. 4. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. 5. Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. 6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 7. Have adequate organ function prior to the start of study intervention. Exclusion Criteria: 1. A WOCBP who has a positive urine pregna
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