Recruiting

Sacituzumab Govitecan for Recurrent or Persistent Cervical Cancer

Study Aim

This study aims to evaluate the effectiveness of Sacituzumab Govitecan as a treatment for recurrent or persistent cervical cancer, specifically measuring the rate of complete and partial responses in patients.

What is being tested

Sacituzumab govitecan

Drug

Who is being recruted

Urogenital Diseases+10

+ Genital Diseases

+ Uterine Cervical Diseases

Over 18 Years

+38 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: June 2023

See protocol details

Summary

Principal SponsorYale University

Study ContactAlessandro D. Santin, MDMore contacts

Last updated: February 7, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 2, 2023

Actual date on which the first participant was enrolled.

This study focuses on evaluating the effectiveness of a drug called Sacituzumab Govitecan in treating patients with cervical cancer that has either returned or persisted despite previous treatment. The goal is to understand how well this drug works in managing this specific condition, as it is an anti-Trop-2-SN-38 antibody-drug conjugate designed to target cancer cells. The potential outcomes of this study could lead to improved treatment options for individuals dealing with recurrent or persistent cervical cancer. During this Phase 2 study, participants receive Sacituzumab Govitecan as part of their treatment regimen. The study measures the results by looking at the objective response rate, which includes both complete and partial responses. This is assessed using specific criteria known as RECIST 1.1. In simpler terms, the study evaluates how many patients experience a reduction in their tumor size or complete disappearance of tumors after receiving the treatment.

Official TitleA 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

NCT05838521

Principal SponsorYale University

Study ContactAlessandro D. Santin, MDMore contacts

Last updated: February 7, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesUterine Cervical DiseasesUterine Cervical NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleNeoplasmsNeoplasms by SiteUrogenital NeoplasmsUterine DiseasesUterine NeoplasmsFemale Urogenital Diseases

Criteria

18 inclusion criteria required to participate

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.

Show More Criteria

20 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Sacituzumab govitecan, 10 mg/kg for the first 2 weeks of 21-day cycle until progression or adverse effects prohibit further treatment.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Smilow Cancer Hospital at Yale New Haven

New Haven, United StatesOpen Smilow Cancer Hospital at Yale New Haven in Google Maps

Recruiting

Cleveland Clinic

Cleveland, United States

Recruiting

2 Study Centers