a study of sacituzumab govitecan (immu-132) in patients with recurrent or persistent cervical cancer

Conditions: Cervical Cancer

Summary: this is a non-randomized phase 2 study of sacituzumab govitecan (immu-132) in subjects with recurrent or persistent cervical cancer.

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 criteria:
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. * 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, granulocytes 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 \< or equal to 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 their cervical cancer. * 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 be practicing an effective form of contraception during the study and until conclusion of 12-week post-treatment evaluation period. * patients must be at least 18 years of age. exclusion criteria: * patients with a positive serum pregnancy test or women who are breastfeeding. * patients with known hypersensitivity to the study drug, its metabolites, or formulation excipient. * patients who require ongoing therapy with or prior use of any prohibited medication(s) such as ugt1a1 inhibitors. * have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations. * any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the patient's participation in the study. * patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancers or carcinoma in situ of the cervix, are excluded if there is any evidence of other malignancy being present within the last 5 years. * patients with a significant history of cardiac disease within 6 months, i.e., uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure (nyha classification iii-iv) or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring antiarrhythmia therapy. * patients with known history of clinically significant active copd, or other moderate-to-severe chronic respiratory illness present within 6 months * patients with any unstable medical issue (including cardiac issues as above, active treatment for symptomatic pulmonary embolism, cva, renal or hepatic insufficiency, and active infection/sepsis requiring iv antibiotics). * have known active cns metastases and/or carcinomatous meningitis. patients with previously treated brain metastases may participate provided they have stable cns disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking ≤20 mg/day of prednisone or its equivalent. all patients with carcinomatous meningitis are excluded regardless of clinical stability * patients who have an uncontrolled seizure disorder, or active neurological disease. * have known history of hiv-1 or 2 (or positive hiv-1/2 antibody) with detectable viral load or taking medications that may interfere with sn-38 metabolism * have active hbv or hcv. in subjects with a history of hbv or hcv, subjects with a detectable viral load will be excluded. * known hemorrhagic diathesis or active bleeding disorder. * patients with gilbert's disease * presence of bulky disease (defined as any single mass \>7 cm in its greatest dimension). patients with a mass over 7 cm, but otherwise eligible, may be considered for enrollment after discussion and approval with the study pi. * patients with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction. * prior history of intestinal obstruction within 6 months of initiation of study treatment. * patients with a history of an anaphylactic reaction to irinotecan or ≥ grade 3 toxicity to prior irinotecan. * have previously received topoisomerase i inhibitors