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Study on Mirvetuximab Soravtansine and Carboplatin for Patients with Recurrent Ovarian Cancer Eligible for Platinum-Based Chemotherapy

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of recurrent ovarian cancer, a type of cancer that returns after initial treatment. The study involves a new treatment called Mirvetuximab soravtansine, which is being tested in combination with a chemotherapy drug called Carboplatin. The purpose of the study is to evaluate the effectiveness and safety of this combination in patients whose cancer has a high level of a protein called folate receptor alpha and who are eligible for platinum-based chemotherapy.

Participants in the study will receive either the new treatment combination or a standard treatment, which may include drugs like Gemcitabine, Paclitaxel, Doxorubicin, Rucaparib, Olaparib, or Niraparib. Some participants may receive a placebo. The study will monitor the time it takes for the cancer to progress or for the patient to pass away, whichever happens first. This is known as progression-free survival. The study will also look at overall survival, which is the time from the start of the study until death from any cause, and the response rate, which measures how well the cancer responds to the treatment.

The trial will last for several years, and participants will be closely monitored throughout the study. The study aims to provide valuable information about the potential benefits and risks of using Mirvetuximab soravtansine with Carboplatin in treating recurrent ovarian cancer. This research could lead to new treatment options for patients with this type of cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will undergo initial assessments to confirm eligibility. This includes providing a sample of tumor tissue for testing and ensuring all health criteria are met.
Step 2
Treatment initiation
The patient will begin treatment with mirvetuximab soravtansine and carboplatin. Mirvetuximab soravtansine is administered as an injection, while carboplatin is given as an intravenous infusion.
The treatment cycle is repeated every three weeks, with the specific dosage and duration determined by the healthcare provider based on individual patient needs.
Step 3
Ongoing treatment and monitoring
Throughout the trial, the patient will receive regular doses of the medications as prescribed. Monitoring will include regular health assessments and imaging tests to evaluate the response to treatment.
The patient's progression-free survival, which is the time during and after treatment that the patient lives without the disease worsening, will be closely monitored.
Step 4
Completion of treatment
The treatment will continue until the disease progresses or unacceptable side effects occur. The healthcare team will provide guidance on the next steps based on the patient's response to the treatment.
Step 5
Follow-up
After completing the treatment, the patient will have follow-up visits to monitor overall survival and any long-term effects of the treatment. These visits will help assess the patient's quality of life and any ongoing health needs.

Who can join the trial?

13 criteria

All patients must have a confirmed diagnosis of epithelial cancer of the ovary, fallopian tube, or peritoneum.
Patient must be female and at least 18 years old at the time of the first screening visit.
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means they are fully active or have some symptoms but do not need to stay in bed for more than half of the day.
Patients must be willing and able to sign the informed consent form and follow the study visit schedule and other requirements.
Women who can have children must have a negative pregnancy test within 3 days before starting the study treatment and agree to use a highly effective method of birth control during the study and for at least 8 months after the treatment ends. These methods include hormonal birth control, intrauterine devices, or having a partner who has had a vasectomy.
Patients must have a relapsed disease with a platinum-free interval of more than 3 months, meaning the cancer returned after being treated with platinum-based chemotherapy and staying away for more than 3 months.
All types of ovarian carcinoma, including carcinosarcoma, are allowed.
Patients with normal BRCA1/2 genes or those with harmful BRCA1/2 mutations who have had PARP inhibitor therapy in previous treatments can participate.
Patients must be willing to provide tumor tissue samples from current or past surgeries/biopsies to confirm high levels of a protein called FRα in the tumor cells.
Patients must have measurable disease or disease that can be evaluated using specific criteria, including a blood test called CA-125.
Patients must have had one or more previous chemotherapy treatments, with the last one including at least 4 cycles of platinum-based chemotherapy that resulted in a partial or complete response.
Any major surgery must be completed at least four weeks before starting the study treatment.
Patients must have adequate blood, liver, heart, and kidney function, which includes specific levels of hemoglobin, neutrophils, platelets, bilirubin, liver enzymes, and creatinine.

Who cannot join the trial?

5 criteria

Patients who are not female cannot participate in the study.
Patients who are not eligible for platinum-based chemotherapy cannot participate.
Patients who do not have recurrent ovarian cancer cannot participate.
Patients who do not have high levels of a specific protein called **FRα** cannot participate. This protein is found on the surface of some cancer cells.
Patients who are part of a vulnerable population, meaning they might need special protection or care, cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Charite Universitaetsmedizin Berlin KöR
Verified
Berlin, Germany
Goethe University Frankfurt
Verified
Frankfurt, Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Verified
Ulm, Germany

Trial locations

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Investigated drugs

Mirvetuximab soravtansine (IMGN853) is a medication being studied for its effectiveness in treating ovarian cancer that has come back and is eligible for platinum-based chemotherapy. It works by targeting a specific protein called folate receptor alpha (FRα) that is often found in high amounts on the surface of ovarian cancer cells. By binding to this protein, the medication delivers a toxic substance directly to the cancer cells, which may help to kill them and slow down the progression of the disease.

What is already known about the treatment

Mirvetuximab soravtansine – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating recurrent ovarian cancer with high folate receptor alpha expression. It is not yet widely used in standard medical practice but shows promise in ongoing research. The main therapeutic indication is for patients with ovarian cancer who are eligible for platinum-based chemotherapy. At the molecular level, Mirvetuximab soravtansine works by targeting and binding to the folate receptor alpha on cancer cells, delivering a cytotoxic agent directly to the tumor, which helps to kill the cancer cells. It is classified as an antibody-drug conjugate, combining a monoclonal antibody with a potent anti-cancer drug.

Investigated diseases

Ovarian Cancer – Ovarian cancer is a type of cancer that begins in the ovaries, which are the female reproductive glands. It often goes undetected until it has spread within the pelvis and abdomen. In its early stages, it may not cause noticeable symptoms, but as it progresses, symptoms can include abdominal bloating, pelvic pain, and changes in bowel habits. The disease can spread to other parts of the body, making it more challenging to treat. It is typically classified by the type of cell where the cancer begins, with epithelial ovarian cancer being the most common. The progression of the disease is often monitored using criteria such as the Response Evaluation Criteria in Solid Tumors (RECIST).