eligibility_summary
Adults ≥18, ECOG 0–2, muscle‑invasive urothelial carcinoma of bladder/ureter/renal pelvis after curative radical cystectomy or nephroureterectomy (≤180 d), disease‑free on imaging, high‑risk pathology, adequate organ/marrow function. Prior neoadjuvant chemo allowed, if chemo‑naive, cisplatin‑ineligible/decline. Consent, contraception. Exclude partial surgery, prior adjuvant/UC RT, prior PD‑1/PD‑L1 or sacituzumab, metastasis, autoimmune/ILD, high‑dose steroids, major comorbidities/infections, pregnancy/lactation, recent live vaccine.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm adjuvant trial in high-risk muscle-invasive urothelial carcinoma post-surgery. Interventions: Sacituzumab govitecan (SG) plus nivolumab for 4 cycles, then nivolumab alone for 11 cycles. Mechanisms: SG is an antibody–drug conjugate targeting Trop-2 on tumor cells, delivering SN-38 (irinotecan’s active metabolite), a topoisomerase I inhibitor that causes DNA damage and tumor cell death (with a potential bystander effect). Nivolumab is a PD-1–blocking IgG4 monoclonal antibody (checkpoint inhibitor) that restores anti-tumor T-cell activity. Targets/pathways: Trop-2–expressing urothelial cancer cells, DNA topoisomerase I, PD-1 on T cells and the PD-1/PD-L1(L2) immune checkpoint in the tumor microenvironment. Aim: eradicate micrometastatic disease and lower recurrence risk.