Adjuvant Sacituzumab Govitecan and Nivolumab in Muscle-Invasive Urothelial Carcinoma at High-Risk Recurrence
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Underwent a partial cystectomy or partial nephrectomy.
History of adjuvant platinum-based chemotherapy or any other type of adjuvant therapy, including investigational agents, following surgical removal of UC.
History of treatment with PD-1/PD-L1 inhibitors or sacituzumab govitecan prior to study treatment initiation.
History of previous radiation therapy for treatment of UC.
Trial design
Treatments tested in this trial
- Sacituzumab Govitecan (SG)
- Nivolumab
Treatment groups
23 Participants
are divided into 1 treatment groupSponsors and collaborators
University of California, Irvine
Lead sponsor
Gilead Sciences
Collaborator
Source ClinicalTrials.gov