🏛️ Verified NIH Record • Updated 2026-07-24

A Study of Sacituzumab Govitecan (IMMU-132) in Patients With Recurrent or Persistent Cervical Cancer (NCT05838521)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Yale University

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (18 items) and avoid the listed exclusions (21 items).

Location: Smilow Cancer Hospital at Yale New Haven — New Haven, Connecticut

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

  • Smilow Cancer Hospital at Yale New Haven — New Haven, Connecticut
  • Cleveland Clinic — Cleveland, Ohio

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗