Actively Recruiting
A Study of Sacituzumab Govitecan (IMMU-132) in Patients With Recurrent or Persistent Cervical Cancer
Led by Yale University · Updated on 2026-02-06
20
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a non-randomized Phase 2 study of sacituzumab govitecan (IMMU-132) in subjects with recurrent or persistent cervical cancer.
CONDITIONS
Official Title
A Study of Sacituzumab Govitecan (IMMU-132) in Patients With Recurrent or Persistent Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients with radiologically confirmed recurrent or persistent cervical cancer of epithelial origin
- Progressed after at least one prior chemotherapy treatment regimen
- Availability of archival tumor tissue FFPE block for TROP-2 testing
- Measurable disease with at least one target lesion per RECIST v1.1
- Patients with recurrent disease of any substage (I-IV) eligible
- Adequate bone marrow function: WBC 2,000/ul, Platelets 2,000/ul, Granulocytes 2,000/ul
- Adequate renal function: creatinine 2.0 mg/dL
- Adequate hepatic function: bilirubin 1.5 institutional upper limit of normal, AST and ALT 2.5 �d7 IULN or 5 �d7 IULN if liver metastases
- ECOG performance status 0 or 1
- Signed approved informed consent
- At least 2 weeks beyond prior treatments or major surgery
- At least 2 weeks beyond high dose systemic corticosteroids (low dose 20 mg prednisone daily permitted)
- Recovery from acute toxicities to Grade 1 or less (exceptions for Grade 2 neuropathy or alopecia)
- No more than 2 prior chemotherapies for cervical cancer
- Prior immunotherapy allowed with 4-week washout
- Negative pregnancy test within 7 days prior to study entry and effective contraception
- Age 18 or older
You will not qualify if you...
- Positive serum pregnancy test or breastfeeding
- Known hypersensitivity to sacituzumab govitecan or its components
- Ongoing or prior use of prohibited medications such as UGT1A1 inhibitors
- Concurrent medical or psychiatric conditions that may interfere with study
- Any medical condition posing undue risk for participation
- History of other invasive malignancies in last 5 years except certain skin or cervical cancers
- Significant cardiac disease within 6 months
- Active moderate-to-severe chronic respiratory illness within 6 months
- Unstable medical issues including active infections requiring IV antibiotics
- Active CNS metastases or carcinomatous meningitis
- Uncontrolled seizure disorder or active neurological disease
- Known HIV infection with detectable viral load or interfering medications
- Active hepatitis B or C virus infection
- Known bleeding disorders or Gilbert's disease
- Bulky disease with mass over 7 cm without prior approval
- Active grade 2 or higher anorexia, nausea, vomiting, or intestinal obstruction
- Prior intestinal obstruction within 6 months
- History of anaphylactic reaction to irinotecan or severe toxicity to prior irinotecan
- Prior treatment with topoisomerase I inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States, 06520
Actively Recruiting
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
A
Alessandro D. Santin, MD
CONTACT
L
Lisa Baker, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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