Study on Carboplatin and Mirvetuximab Soravtansine for Initial Treatment in Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Sponsor: University of Alabama at Birmingham
ClinicalTrials ID:NCT04606914
This clinical trial is testing a combination of the drugs carboplatin and mirvetuximab soravtansine as a first-line treatment for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer. The study aims to see if this combination is safe and effective when given before surgery.
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Program Overview
The study is designed to test the safety and effectiveness of combining carboplatin and mirvetuximab soravtansine in patients with advanced-stage ovarian, fallopian tube, or primary peritoneal cancer. Patients will receive chemotherapy with carboplatin and mirvetuximab soravtansine before surgery to see if it helps control the cancer. The study will include 70 patients, and the treatment will be given in cycles every 21 days. After completing the initial treatment cycles, patients will undergo surgery and may receive additional cycles of the drug combination. The study will also explore the option of adding another drug, bevacizumab, to the treatment plan.
Description
Mirvetuximab soravtansine is a drug that targets a specific protein found on the surface of certain cancer cells, including those in ovarian, fallopian tube, and primary peritoneal cancers. This study will test if combining mirvetuximab soravtansine with carboplatin, a standard chemotherapy drug, can improve treatment outcomes for patients with advanced cancer.
Patients will first receive a cycle of carboplatin alone, followed by three cycles of carboplatin and mirvetuximab soravtansine before surgery. After surgery, patients will receive three more cycles of the drug combination. Doctors may choose to add bevacizumab, another cancer drug, to the last two cycles or use other maintenance therapies.
The study will monitor patients for side effects and how well the cancer responds to the treatment. Patients will have regular check-ups and imaging tests to track their progress. The study aims to improve survival rates and control the cancer more effectively than current treatments.
Patients will be followed for their overall survival and any side effects they experience during and after the treatment. The study will also assess how long patients remain free of cancer after treatment and the overall response rate before surgery.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of high-grade serous ovarian cancer.
- Cancer must be at stage III or IV and suitable for chemotherapy before surgery.
- Must provide a tumor sample for testing or agree to a new biopsy.
- Must have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
- Tumor must show high levels of a specific protein (FRα).
- Must have adequate blood, liver, and kidney function based on specific medical tests.
- Must agree to use effective birth control during the study and for four months after the last dose.
- Women must have a negative pregnancy test before starting treatment.
Exclusion Criteria
- Have received previous cancer treatment.
- Have certain types of ovarian cancer, such as low-grade serous or clear cell.
- Have active eye conditions or a history of corneal transplants.
- Have serious illnesses or infections, including hepatitis or HIV.
- Have a history of certain neurological or heart conditions.
- Have had a stroke or severe heart issues in the past six months.
- Have liver disease or lung disease.
- Require folate supplements.
- Have allergies to similar drugs.
- Are pregnant or breastfeeding.
- Have untreated or symptomatic brain metastases.
- Have had another cancer within the past three years, except for certain skin cancers or cervical cancer.
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