A Phase II Evaluation of Sacituzumab Govitecan (IMMU-132), an Anti-Trop-2-SN-38 Antibody-drug Conjugate in Patients With Recurrent or Persistent Cervical Cancer
Yale University
Summary
This is a non-randomized Phase 2 study of sacituzumab govitecan (IMMU-132) in subjects with recurrent or persistent cervical cancer.
Description
This is an open-label, Phase 2 study designed to assess the clinical activity of sacituzumab govitecan in subjects with recurrent or persistent cervical cancer.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have radiologically confirmed (i.e., CAT scan and/or MRI) persistent or recurrent histologically confirmed cervical cancer of epithelial origin who have progressed following at least one prior chemotherapy treatment regimen. * Must have availability of archival tumor tissue FFPE block for TROP-2 testing * Chemotherapy administered concurrent with primary radiation (i.e., weekly cisplatin) is not counted as a systemic chemotherapeutic regimen for management of persistent or recurrent carcinoma of the cervix. * All patients must have measurable disease.…
Interventions
- DrugSacituzumab govitecan
This is a non-randomized Phase 2 study of sacituzumab govitecan (IMMU-132).
Locations (2)
- Smilow Cancer Hospital at Yale New HavenNew Haven, Connecticut
- Cleveland ClinicCleveland, Ohio