A Study of Sacituzumab Govitecan (IMMU-132) in Platinum-resistant Ovarian Cancer Patients

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 enrollment.
• •Patients must have adequate bone marrow function: WBC greater than or equal to 3,000/ul, Platelets greater than or equal to 75,000/ul, Neutrophils greater than or equal to 1500/ul.
• •Patients must have adequate renal function: creatinine less than or equal to 2.0 mg/dL.
• •Patients must have adequate hepatic function: bilirubin ≤ 1.5 institutional upper limit of normal, aspartate aminotransferase \[AST\], and alanine aminotransferase \[ALT\] ≤ 2.5 × IULN or ≤ 5 × IULN if known liver metastases
• •Patients must have an ECOG performance status of 0 or 1.
• •Patients must have signed an approved informed consent.
• •Patients must be at least 2 weeks beyond prior treatment (chemotherapy, investigational drugs including small molecular inhibitors, endocrine therapy, immunotherapy and/or radiation therapy) or major surgery.
• •Patients must be at least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids \<20 mg prednisone or equivalent daily are permitted)
• •Patients must have recovered from all acute toxicities to Grade 1 or less from adverse events due to a previously administered agent
• •* Note: Patients with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study
• •* Note: If patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
• •Patients with recurrent disease may have received no more than 2 prior chemotherapies for treatment of the recurrent ovarian cancer.
• •* Adjuvant ± neoadjuvant are considered one line of therapy
• •* Maintenance therapy (eg, bevacizumab, PARP inhibitors) are considered as part of the preceding line of therapy (ie, not counted independently).
• •* Therapy changed due to toxicity or allergy in the absence of progression will be considered as part of the same line (ie, not counted independently).
• •Patients may have received prior immunotherapy therapy alone or in combination with chemotherapy. A 4-week washout period is required between prior immunotherapy treatment and first dose of sacituzumab govitecan.
• •Patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the study entry and must agree to use protocol-specific method(s) of contraception. .
• •Patients must be at least 18 years of age.