A Pilot Study of Pembrolizumab Monotherapy as Maintenance Therapy in MIBC Patients Who Received Bladder-Preserving Trimodally Therapy and Achieved CR
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.
• Male/female participants who are at least 18 years of age on the day of signing informed consent.
• 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.
• Tumor was located at one side of bladder wall.
• The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
• 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.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Have adequate organ function prior to the start of study intervention.