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.
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.