A Study of Sacituzumab Govitecan (IMMU-132) in Patients With Recurrent or Persistent Cervical Cancer

Trial Title: A Study of Sacituzumab Govitecan (IMMU-132) in Patients With Recurrent or Persistent Cervical Cancer

NCT ID: NCT05838521

Condition: Cervical Cancer

Conditions: Official terms:
Uterine Cervical Neoplasms
Sacituzumab govitecan

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Sacituzumab govitecan
Description: This is a non-randomized Phase 2 study of sacituzumab govitecan (IMMU-132).
Arm group label: Sacituzumab Govitecan

Other name: Trodelvy

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

Detailed 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.

Criteria for 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

Gender: Female

Gender based: Yes

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Smilow Cancer Hospital at Yale New Haven

Address:
City: New Haven
Zip: 06520
Country: United States

Status: Recruiting

Contact:
Last name: Alessandro D. Santin, M.D

Phone: 203-737-4450
Email: alessandro.santin@yale.edu

Contact backup:
Last name: Lisa Baker, R.N

Phone: 203-785-6398
Email: lisa.baker@yale.edu

Start date: June 2, 2023

Completion date: June 1, 2028

Lead sponsor:
Agency: Yale University
Agency class: Other

Collaborator:
Agency: Gilead Sciences
Agency class: Industry

Source: Yale University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05838521