A Study of Sacituzumab Govitecan (IMMU-132) in Platinum-resistant Ovarian Cancer Patients (NCT06028932) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Sacituzumab Govitecan (IMMU-132) in Platinum-resistant Ovarian Cancer Patients
United States20 participantsStarted 2024-01-08
Plain-language summary
This is a non-randomized Phase 2 study of sacituzumab govitecan (IMMU-132) in subjects with recurrent or persistent platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancers.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Patients must have platinum-resistant (i.e., platinum-free interval \<6 months) recurrent or persistent histologically confirmed epithelial (non-mucinous) ovarian, fallopian tube, or primary peritoneal cancer. Patients may have serous, endometrioid, clear cell, (pure or mixed), or undifferentiated histology.
* Must have availability of archival tumor tissue FFPE block for TROP-2 testing and other biomarkers.
* All patients must have measurable disease. Measurable disease is defined as lesions which can be measured by physical examination or by means of medical imaging techniques. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be ≥ 20 mm when measured by conventional techniques, including palpation or plain x-ray, or ≥ 10 mm when measured by spiral CT and/or MRI. Ascites and pleural effusions are not to be considered measurable disease.
* Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST v1.1. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented, or a biopsy is obtained to confirm persistence following completion of radiation therapy.
* After undergoing surgery, patients may be optimally or sub optimally debulked.
* Patients with measurable recurrent disease of any previous substage (I-IV) are eligible to …