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
- Study HIC#:2000023639
- Last Updated:08/24/2023
This is a non-randomized Phase 2 study of sacituzumab govitecan (IMMU-132) in subjects with recurrent or persistent cervical cancer.
For more information about this study, including how to volunteer, contact:
- Phone Number: 1-203-785-6398
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Trial Purpose and 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.
- 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.
- 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 <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.
- 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.
- 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