Muscle-invasive Urothelial Carcinoma of the Bladder Clinical Trial
Official title:
An Open Label, Single-arm, Phase 2 Study of Perioperative Pembrolizumab Plus Sacituzumab Govitecan for Patients With Muscle-invasive Bladder Cancer Who Cannot Receive or Refuse Cisplatin-based Chemotherapy
This is a perioperative Phase 2, open-label, non-randomized, single-cohort study in patients with urothelial carcinoma of the bladder who cannot receive or refuse to receive cisplatin-based chemotherapy.
A transurethral resection of the bladder tumor (TURBT) for biopsy, histological characterization, and local staging will be executed first, according to the guidelines. Eligible patients will receive neoadjuvant treatment: 10 mg/kg sacituzumab govitecan IV, on days 1, 8, of each 21 day cycle. Pembrolizumab will be administered in combination with sacituzumab on day 1, every 21 days, at the standard dose of 200 mg intravenously. A total of 4 cycles is planned before surgery. Surgery will be planned at the time of study inclusion to be done ideally within 4 weeks of the last dose of study drug, and not later than 12 weeks from the last dose of study drug. After surgery patients will receive additional 13 cycles of pembrolizumab at the standard dose, every 3 weeks, accounting for a total of 17 cycles of perioperative pembrolizumab (neoadjuvant + adjuvant). Imaging assessments post-cystectomy will be managed according to the current EAU guidelines. At the end of the adjuvant period, patients will enter the follow-up period which will last until 12 months from the last dose of pembrolizumab. ;