Study on Sacituzumab Govitecan for Patients with Recurrent or Persistent Cervical Cancer
Sponsor: Yale University
ClinicalTrials ID:NCT05838521
This clinical trial is testing the effectiveness of a drug called sacituzumab govitecan in treating patients with cervical cancer that has returned or is not responding to previous treatments.
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Program Overview
This study is exploring the use of sacituzumab govitecan, a medication aimed at treating cervical cancer that has come back or is not responding to other treatments. The trial is in Phase 2, which means it is focused on understanding how well the drug works and its safety in patients with this type of cancer.
Description
This clinical trial is open to patients with cervical cancer that has returned or is persistent after previous treatments. The study will assess how well sacituzumab govitecan works in treating this type of cancer. Participants will receive the drug and be monitored for its effects on their cancer and overall health. The study aims to provide insights into the drug's effectiveness and safety for future treatment options.
Eligibility Criteria
Inclusion Criteria
- Have cervical cancer that has returned or is persistent, confirmed by scans and lab tests.
- Have previously received at least one chemotherapy treatment.
- Have a tumor sample available for testing.
- Have measurable cancer that can be tracked during the study.
- Be in good overall health with adequate blood, kidney, and liver function.
- Be at least 18 years old.
- Have recovered from any previous treatments or surgeries.
- Women of childbearing potential must have a negative pregnancy test and use effective contraception during the study.
- Be willing to sign an informed consent form.
Exclusion Criteria
- Pregnant or breastfeeding women.
- Have allergies to the study drug or its components.
- Have other serious medical or psychiatric conditions that could interfere with the study.
- Have had another type of cancer within the last 5 years, except for certain skin cancers or cervical cancer in situ.
- Have significant heart or lung disease.
- Have active infections like HIV, hepatitis B, or hepatitis C.
- Have active brain cancer or neurological disorders.
- Have a history of severe reactions to similar drugs.
- Have large tumors over 7 cm, unless approved by the study investigator.
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