Actively Recruiting
Adjuvant Sacituzumab Govitecan and Nivolumab in Muscle-Invasive Urothelial Carcinoma at High-Risk Recurrence
Led by University of California, Irvine · Updated on 2026-04-30
23
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
Sponsors
U
University of California, Irvine
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adjuvant Sacituzumab Govitecan and Nivolumab in Muscle-Invasive Urothelial Carcinoma at High-Risk Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63; 18 years at the time of study consent.
- ECOG Performance Status of 0, 1 or 2.
- Histologically confirmed muscle-invasive urothelial carcinoma of the bladder, ureter, or renal pelvis; variant histology allowed except small cell carcinoma.
- Curative-intent surgery (radical cystectomy or nephroureterectomy) performed within 180 days before starting study treatment.
- Radiographic disease-free status within 28 days before starting study treatment.
- Prior platinum-based neoadjuvant chemotherapy allowed; if chemotherapy-naive, must be cisplatin-ineligible or refuse platinum adjuvant chemotherapy.
- Prior neoadjuvant investigational agents allowed except PD-1/PD-L1 inhibitors or Sacituzumab Govitecan.
- High risk for cancer recurrence based on pathological staging after surgery.
- Adequate organ and marrow function as defined by specific blood counts and biochemical values.
- Agreement to use medically accepted contraception during treatment and for 6 months afterward.
- Female subjects of childbearing potential must not be pregnant.
- Recovery to 64; Grade 1 of toxicities from prior urothelial carcinoma treatment unless clinically non-significant.
- Subjects with genitourinary catheters are allowed.
- Ability and willingness to sign informed consent; all races and ethnic groups eligible; non-English speaking, hard of hearing, and illiterate individuals eligible.
You will not qualify if you...
- Underwent partial cystectomy or partial nephrectomy.
- History of adjuvant platinum-based chemotherapy or other adjuvant therapy after surgery.
- Prior treatment with PD-1/PD-L1 inhibitors or Sacituzumab Govitecan before study treatment.
- Prior radiation therapy for urothelial carcinoma.
- Radiographic evidence of metastasis.
- Use or planned use of other investigational agents concurrently.
- History of active, known, or suspected autoimmune disease.
- Use of systemic high-dose corticosteroids or other immunosuppressants within 14 days before treatment.
- History of certain lung diseases or active pneumonitis.
- Recent major or minor surgery within 28 or 14 days respectively before first treatment dose.
- Active malignancy within 3 years except certain localized cancers.
- Inadequate organ or marrow function.
- Uncontrolled infections or illnesses including HIV, hepatitis B or C, severe liver impairment, tuberculosis, serious heart conditions, recent stroke or ischemic events, severe bleeding, or severe diarrhea.
- History of inflammatory bowel disease or conditions with high diarrhea risk.
- Psychiatric or social conditions preventing study compliance.
- Pregnancy or breastfeeding.
- Receipt of live vaccine within 28 days before treatment.
- Known severe hypersensitivity to study drugs or components.
- Any other condition or abnormality that may interfere with study participation or results, as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
Research Team
C
Chao Family Comprehensive Cancer Center University of California, Irvine
CONTACT
U
University of California Irvine Medical
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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