Study on Mirvetuximab Soravtansine for Women with Folate Receptor-α Positive Endometrial Cancer
Sponsor: Alessandro Santin
ClinicalTrials ID:NCT03832361
This clinical trial is testing the safety and effectiveness of a new drug, mirvetuximab soravtansine, in women with certain types of endometrial cancer that have a high level of folate receptor alpha. The study aims to see if the drug can help control the cancer and improve survival rates.
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Program Overview
The purpose of this study is to evaluate how well the drug mirvetuximab soravtansine works and how safe it is for women with specific types of endometrial cancer that have high levels of folate receptor alpha. The study will look at how the drug affects cancer growth and survival, and will also explore if certain markers in the blood can help predict how well the treatment works.
Description
This study is for women with certain types of endometrial cancer that have come back or are not responding to treatment. These include uterine serous carcinoma, high-grade endometrial adenocarcinoma, or carcinosarcoma with specific features. Participants must have cancer that can be measured by scans. The main goal is to see how well the drug mirvetuximab soravtansine works in shrinking tumors. The study will also look at how long patients live without the cancer getting worse and how long they live overall. Researchers will also study the safety of the drug and how it affects the body. All participants will receive the drug through an IV every three weeks until the cancer progresses or side effects become too severe. The study will also explore if blood tests can help predict how well the treatment works compared to traditional cancer markers.
Eligibility Criteria
Inclusion Criteria
- Have endometrial cancer confirmed by scans like CT or MRI.
- Have one of the following types of cancer: Uterine serous carcinoma, high-grade endometrial adenocarcinoma, carcinosarcoma with specific features, or clear cell carcinoma.
- Have cancer that can be measured by scans.
- Have a tumor that tests positive for folate receptor alpha.
- Have at least one tumor that can be used to measure response to treatment.
- Have had no more than three previous treatments for recurrent cancer, excluding hormonal treatments.
- Have a good performance status, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have waited a certain amount of time after previous treatments before starting the study.
- Have recovered from side effects of previous chemotherapy.
- Have adequate blood, liver, and kidney function.
- Women of childbearing potential must use effective birth control during the study and for 12 weeks after the last dose.
- Must have a negative pregnancy test before starting the study.
- Must have signed an informed consent form and be willing to follow study procedures.
- Be 18 years or older.
Exclusion Criteria
- Have an active or long-term eye disorder affecting the cornea.
- Have a serious illness or active infection.
- Have significant heart disease, such as recent heart attack, unstable chest pain, or uncontrolled heart failure.
- Have a history of neurological conditions.
- Have had a stroke in the last 6 months.
- Have liver disease.
- Have had non-infectious lung inflammation.
- Have allergies to monoclonal antibodies.
- Are pregnant or breastfeeding.
- Have cancer that has spread to the brain or spinal cord and is untreated or causing symptoms.
- Have a history of blood clotting or bleeding disorders in the last 6 months.
- Need to take folate supplements.
- Have another active cancer that required treatment in the last 3 years.
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