Actively Recruiting
Adjuvant Sacituzumab Govitecan Plus Nivolumab in Patients With Muscle-Invasive Urothelial Carcinoma at High-Risk for Recurrence
Led by University of California, Irvine · Updated on 2026-04-30
23
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating a phase 2, single-arm clinical trial of adjuvant combination therapy with Sacituzumab Govitecan and Nivolumab in patients who have muscle-invasive urothelial carcinoma of the bladder, ureter, or upper tract. These patients are considered high risk for cancer recurrence after curative-intent surgery based on surgical pathology. The study aims to understand the effects of this combination therapy in reducing recurrence risk in this population. Participants will receive the combination treatment of Sacituzumab Govitecan and Nivolumab administered intravenously for 4 cycles. This is followed by an additional 11 cycles of single-agent Nivolumab. The treatment is designed to be given after surgery and aims to assess outcomes over an extended period. During the study, participants will undergo various assessments including imaging to confirm disease-free status before starting treatment and ongoing monitoring for cancer recurrence or progression. Researchers will track outcomes such as disease-free survival, time to distant metastases or death, and changes in circulating tumor DNA over up to 5 years. Safety and recovery from prior treatments will also be monitored throughout the trial period.
CONDITIONS
Brief 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 18 years or older 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)
- Underwent curative-intent surgery (radical cystectomy or nephroureterectomy) within 180 days prior to study treatment
- Radiographic disease-free status within 28 days before starting treatment
- Prior platinum-based neoadjuvant chemotherapy allowed; chemotherapy-naive patients 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 pathology
- Adequate organ and marrow function as defined by specific blood and chemistry criteria
- Agreement to use medically accepted contraception during treatment and for 6 months after last dose
- Female subjects of childbearing potential must not be pregnant
- Recovery to Grade 1 or better from any prior treatment-related toxicities
- Subjects with genitourinary catheters allowed
- Ability and willingness to provide informed consent
You will not qualify if you...
- Underwent partial cystectomy or partial nephrectomy
- Prior adjuvant platinum-based chemotherapy or other adjuvant therapy after surgery
- Previous treatment with PD-1/PD-L1 inhibitors or sacituzumab govitecan
- History of radiation therapy for urothelial carcinoma
- Radiographic evidence of metastasis
- Receiving or planning to receive other investigational agents concurrently
- Active, known, or suspected autoimmune disease
- Treatment with systemic high-dose corticosteroids or immunosuppressive medications within 14 days before treatment
- History or evidence of certain lung diseases or active pneumonitis
- Recent major or minor surgery without full wound healing
- Active malignancy within 3 years except certain treated localized cancers
- Inadequate organ or marrow function
- Uncontrolled infections or illnesses including HIV with detectable viral load, hepatitis B or C with detectable viral load, severe liver impairment, tuberculosis, serious heart conditions, recent stroke or myocardial infarction, severe bleeding, or severe diarrhea
- History of inflammatory bowel disease or conditions increasing diarrhea risk
- Psychiatric or social issues impacting compliance
- Pregnancy or breastfeeding
- Received live vaccine within 28 days prior to treatment
- Severe hypersensitivity to study drugs or components
- Any condition or abnormality that might interfere with study participation or results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 15 cycles total
Participants receive combination therapy with Sacituzumab Govitecan and Nivolumab for 4 cycles, followed by single-agent Nivolumab for an additional 11 cycles.
Regular visits for treatment cycles (details per cycle not specified)
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
U
University of California Irvine Medical
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here