Adjuvant Sacituzumab Govitecan Plus Nivolumab in Patients With Muscle-Invasive Urothelial Carcinoma at High-Risk for Recurrence
University of California, Irvine
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugSacituzumab Govitecan (SG)
Given IV
- DrugNivolumab
Given IV
Location
- Chao Family Comprehensive Cancer Center, University of California, IrvineOrange, California