Study on Sacituzumab Govitecan for Treating Recurrent Ovarian, Endometrial, and Cervical Cancers

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06865677

Provider View

This clinical trial is testing a drug called sacituzumab govitecan (SG) to see if it can help treat ovarian, endometrial, or cervical cancers that have returned after standard treatments. The study aims to determine the effectiveness and safety of SG in these patients.

Patient Parameters

Program Overview

The purpose of this study is to evaluate if sacituzumab govitecan (SG), a drug already approved for other cancers, can help treat ovarian, endometrial, or cervical cancers that have come back after at least two rounds of standard treatments. Participants will receive SG through an IV infusion in 21-day cycles, with treatments on days 1 and 8 of each cycle. The study will monitor the effectiveness of SG in shrinking tumors and its safety over a period of up to 5 years.

Description

This study focuses on a drug called sacituzumab govitecan (SG), which targets a protein called TROP2 found in high levels in certain gynecologic cancers. SG is designed to deliver chemotherapy directly to cancer cells, potentially causing them to shrink. The study will test SG in patients with ovarian, endometrial, or cervical cancers that have returned after previous treatments.

Participants will receive SG through an IV infusion on days 1 and 8 of each 21-day cycle. Each infusion takes 1 to 3 hours. The treatment can continue for up to 5 years, as long as it is effective and well-tolerated. Throughout the study, participants will undergo regular imaging scans and tests to monitor their health and the cancer's response to the treatment.

After completing the treatment, participants will have follow-up visits to ensure their safety and monitor any long-term effects. They will also be contacted by phone every 6 months for up to 10 years to check on their health status.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years and older.
  • Diagnosed with recurrent ovarian, endometrial, or cervical cancer that has not responded to at least two previous treatments.
  • Cancer must be measurable by scans and safely biopsied.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Adequate blood counts and organ function.
  • No active brain metastases or untreated central nervous system (CNS) disease.
  • Must not have had major surgery within 4 weeks before starting the study.
  • Must not have received other cancer treatments within 3 weeks before starting the study.
  • Women of childbearing potential must use effective contraception and have a negative pregnancy test before starting the study.
  • Must be willing to sign an informed consent document.

Exclusion Criteria

  • Currently receiving other investigational treatments.
  • Primary platinum-refractory ovarian cancer.
  • Other active invasive cancers.
  • Severe allergic reactions to similar drugs.
  • Prior treatment with TROP2-targeting drugs or topoisomerase 1 inhibitors.
  • Active infections requiring antibiotics.
  • Uncontrolled illnesses that would interfere with the study.
  • Recent history of gastrointestinal issues like perforation or bleeding.
  • Recent live vaccinations.

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