Adjuvant Sacituzumab Govitecan and Nivolumab in Muscle-Invasive Urothelial Carcinoma at High-Risk Recurrence

Inclusion Criteria: * Age ≥ 18 years at the time of study consent. * ECOG Performance Status of 0, 1 or 2 (see Appendix A). * Histologically confirmed muscle-invasive UC originating in the bladder, ureter, or renal pelvis. Variant histology, except small cell carcinoma, is allowed. * Underwent curative-intent surgery (i.e. RC or nephroureterectomy), performed within 180 days prior to study treatment initiation. * Radiographic disease-free status as determined by imaging within 28 days of C1D1 of study treatment. * Prior platinum-based NAC is allowed. If chemotherapy-naive, patient must be Cisplatin-ineligible (based on Galsky et al 2011 \[10\]) or refuse platinum AC. * Prior treatment with neoadjuvant investigational agents is allowed (except PD-1/PD-L1 inhibitors or sacituzumab govitecan). No washout from neoadjuvant therapy is required. * If NAC was given, patient must be considered at high risk for cancer recurrence due to having pathologic T2, T3, T4, or N+ disease on RC or nephroureterectomy surgical spec-imen. * If no NAC was given, patient must be considered at high risk for cancer recurrence due to having pathologic T3, T4, or N+ disease on RC or nephroureterectomy surgical speci-men. * Adequate organ and marrow function as defined below: * ANC ≥ 1000/mcL * Platelets ≥ 100,000/mcL * Total bilirubin ≤ 1.5 × institutional ULN (or ≤ 3.0 × ULN for subjects with Gilbert's disease) * AST/ALT ≤ 3 × institutional ULN * Alkaline phosphatase ≤ 3 × institutional ULN * Serum alb…