University of California, Irvine
This is a phase 2 study, single-arm study of adjuvant combination therapy with Sacituzumab Govitecan and Nivolumab in patients with muscle-invasive urothelial carcinoma of the bladder, ureter, or upper tract, who are high risk for cancer recurrence post curative-intent surgery based on surgical pathology.
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 Cis…
Given IV
Given IV
Arctuva estimate
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