Actively Recruiting
Sacituzumab Govitecan Plus EV in Metastatic UC
Led by Dana-Farber Cancer Institute · Updated on 2025-11-04
106
Participants Needed
1
Research Sites
362 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Phase I of this research study will assess what doses of Sacituzumab Govitecan and Enfortumab Vedotin can be safely combined in the treatment of metastatic urothelial carcinoma (mUC). In Phase II of the study, patients in one of the two cohorts will receive Sacituzumab Govitecan, Enfortumab Vedotin, and Pembrolizumab to assess the efficacy of this drug combination. The names of the study drugs in these investigational combinations are: * Enfortumab Vedotin * Sacituzumab Govitecan * Pembrolizumab
CONDITIONS
Official Title
Sacituzumab Govitecan Plus EV in Metastatic UC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed predominant urothelial carcinoma of bladder, renal pelvis, ureter, or urethra
- ECOG performance status 0-1
- Adequate organ and marrow function as defined by specific blood counts and liver/kidney tests
- Measurable disease by CT or MRI per RECIST 1.1 criteria
- For Cohort A: Received prior platinum-based chemotherapy and checkpoint inhibitor therapy
- For Cohort B: No prior therapy for metastatic urothelial carcinoma; prior immunotherapy allowed if more than 6 months since last dose
- Women of childbearing potential must have negative pregnancy test and agree to use contraception
- Men must agree to use adequate contraception
- Ability to understand and sign informed consent
You will not qualify if you...
- Pregnant or lactating women
- Prior anticancer biologic agents or chemotherapy within 4 weeks (Cohort A) or 26 weeks (Cohort B) before treatment start
- Unresolved toxicities from prior therapy above Grade 1
- Prior treatment with topoisomerase 1 inhibitors, Sacituzumab Govitecan, or Enfortumab Vedotin
- Active second malignancy except certain treated cancers
- Active central nervous system metastases or carcinomatous meningitis
- Active serious cardiac disease, including recent myocardial infarction or severe heart failure
- Active inflammatory bowel disease or recent gastrointestinal perforation
- Active serious infection requiring antibiotics
- Concurrent medical or psychiatric conditions interfering with study
- Use of high-dose steroids or immunosuppressive medications
- History of certain lung diseases or active pneumonitis
- Receiving other investigational agents
- Known allergies to study drugs or excipients
- Uncontrolled illness, diabetes, bone pain, or spinal cord compression
- History of autoimmune disease requiring systemic treatment in past 2 years (with some exceptions)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
B
Bradley A McGregor, MD
CONTACT
M
Merdith Flynn
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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