eligibility_summary
Incl: Adults >=18 with urothelial carcinoma (dominant TCC), cT2-T3bN0M0, ECOG 0-1, planned RC, cisplatin NAC ineligible/refused, adequate counts, liver, CrCl >=30, contraception/neg pregnancy. Excl: prior systemic tx, bladder RT or partial cystectomy, recent live vaccine, antibiotics, or other trials, other active cancer, allergy to study drugs, autoimmune disease/pneumonitis/IBD, catheters, >=3 FN risks, major cardiac disease, HIV/HBV/HCV, high-dose steroids.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 single-arm perioperative regimen combining pembrolizumab and sacituzumab govitecan for muscle-invasive bladder cancer. Pembrolizumab: humanized IgG4 monoclonal antibody immune checkpoint inhibitor targeting PD-1, blocks PD-1/PD-L1 signaling to reverse T-cell exhaustion and restore antitumor immunity. Sacituzumab govitecan: Trop-2–targeted antibody-drug conjugate (humanized anti–Trop-2 mAb linked via hydrolyzable linker to SN-38, the active topoisomerase I inhibitor of irinotecan), binds Trop-2 on tumor cells, is internalized, and releases SN-38 to induce DNA damage and cell death with a bystander effect. Targets: Trop-2–expressing urothelial tumor cells and the PD-1 pathway on T cells within the tumor microenvironment.