Recruiting

A Study of Mirvetuximab Soravtansine, Carboplatin, and Bevacizumab in Adults with Ovarian Cancer

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What is this trial about?

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

This study involves people with ovarian cancer, which is a type of cancer that develops in the ovaries or related tissues. The study will test different treatment combinations that include a medicine called mirvetuximab soravtansine, which is also known by its code name IMGN853. This medicine will be combined with other cancer drugs including carboplatin and bevacizumab. All of these medicines are given through a vein. The purpose of this study is to find out how safe these treatment combinations are and how well they work in treating ovarian cancer, and to determine the best dose of mirvetuximab soravtansine when it is used together with other medicines.

The study is divided into different parts called substudies. In one substudy, people will have a specific type of ovarian cancer that has certain characteristics, including being what doctors call high-grade serous cancer, which is a particular form of the disease. Some people in this substudy will have cancer that does not have certain genetic changes. In another substudy, people will have ovarian cancer that has come back after previous treatment with platinum-based chemotherapy, and their cancer must have returned more than six months after finishing that treatment. People in the study will receive different combinations of the medicines, and doctors will check how their cancer responds to treatment and watch for any side effects.

During the study, doctors will measure several things to understand how well the treatments work and how safe they are. They will count how many people have side effects of any severity, including serious ones, and how many people need to stop treatment because of side effects. They will pay special attention to eye problems, nerve problems, and lung problems that might occur. Doctors will also check whether the cancer shrinks or stops growing by using scans and blood tests. They will measure how long people live without their cancer getting worse and how long the cancer responds to treatment when it does shrink.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment with medication combination
During this clinical trial, treatment will be administered through intravenous infusion, which means the medication will be delivered directly into a vein.
The trial involves three medications: mirvetuximab soravtansine, carboplatin, and bevacizumab. All medications will be given as a concentrate for solution for infusion.
The specific combination of medications, dosage amounts, frequency of administration, and duration of treatment will be determined based on the substudy assigned. However, the exact dosing schedule and treatment duration are not specified in the available information.
Step 2
Safety monitoring and assessments
Throughout the trial, regular monitoring will be conducted to assess how the treatment affects the body.
Specific attention will be given to monitoring for treatment-emergent adverse events, which are any unwanted medical occurrences that happen during or after treatment.
Eye-related side effects will be monitored, as the treatment may affect vision or eye health.
Monitoring will also include checking for peripheral neuropathy, which refers to nerve damage that can cause numbness, tingling, or pain, typically in the hands and feet.
Lung health will be assessed to detect any signs of pneumonitis or interstitial lung disease, which are conditions involving inflammation or scarring of lung tissue.
Step 3
Disease response evaluation
Regular assessments will be performed to measure how the cancer is responding to treatment.
These evaluations will follow standardized criteria called RECIST v1.1, which is a method used to measure changes in tumor size through imaging scans.
Blood tests will measure CA-125 levels, which is a protein that can indicate ovarian cancer activity. Changes in this marker will be assessed using specific criteria.
The duration of any positive response to treatment will be tracked to determine how long the cancer remains controlled.
Assessments will continue to monitor for progression-free survival, which measures the length of time during and after treatment that the cancer does not grow or spread.
Step 4
Ongoing participation throughout the trial period
The trial is expected to continue until approximately January 2029.
Regular visits will be required throughout the treatment period for medication administration, safety monitoring, and disease assessments.
The frequency and timing of these visits will be determined by the specific substudy protocol.
Participation will continue as long as the treatment is tolerated and the disease does not progress, or until other criteria for discontinuation are met.

Who can join the trial?

10 criteria

You must be female
You must be an adult (18 years or older)
You must have ovarian cancer, which is cancer that starts in the ovaries (organs that produce eggs), or primary peritoneal cancer (cancer in the lining of the abdomen), or fallopian tube cancer (cancer in the tubes connecting the ovaries to the uterus)
Your cancer must be high-grade serous type, which means it is a fast-growing form of cancer with specific cell characteristics
You must have an ECOG performance status of 0 or 1, which is a score that shows how well you can carry out daily activities (0 means fully active, 1 means some restrictions but able to do light work)
For one part of the study: Your cancer must be Stage III or IV according to FIGO staging, which means the cancer has spread beyond the ovaries to other parts of the abdomen or body
For one part of the study: Your tumor must test negative for HRD (homologous recombination deficiency), which is a test that shows whether your cancer cells have a specific DNA repair problem
For another part of the study: Your cancer must have come back after receiving 1 or 2 previous treatments with platinum-based chemotherapy, which is a type of cancer medicine containing platinum
For another part of the study: Your cancer must be platinum-sensitive, meaning it came back more than 6 months after finishing your last platinum-based chemotherapy treatment
For another part of the study: You must have measurable disease, which means your cancer can be seen and measured on imaging scans using specific measurement standards called RECIST

Who cannot join the trial?

10 criteria

The study does not include male patients, only female patients can participate
Children and teenagers under 18 years of age cannot participate in this study
Patients who do not have FRα positive ovarian cancer cannot participate. FRα positive means that the cancer cells have a specific protein called folate receptor alpha on their surface
Patients who have had severe allergic reactions to similar medications in the past may not be able to participate
Patients with certain other active cancers at the same time may not be eligible
Patients with severe heart, liver, or kidney problems may not be able to participate
Patients who are pregnant or breastfeeding cannot participate in this study
Patients who have received certain other cancer treatments too recently may need to wait before joining this study
Patients with uncontrolled serious infections or other medical conditions may not be eligible
Patients who cannot follow the study requirements or attend regular visits may not be able to participate

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Verified sites

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

Aalborg University Hospital
Verified
Aalborg, Denmark
Cliniques Universitaires Saint-Luc
Responsive
Woluwe-Saint-Lambert, Belgium
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium

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Investigated drugs

Mirvetuximab Soravtansine is a medication being tested in this study for treating ovarian cancer. It is designed to target a specific protein called folate receptor alpha that is found on some cancer cells. This medication works by attaching to these cancer cells and delivering a substance that helps destroy them. In this trial, it will be given in combination with other treatments to see if it is safe and effective for people with ovarian cancer that has this specific protein marker.

What is already known about the treatment

Mirvetuximab Soravtansine – This is an injectable medication given directly into a vein that is currently being studied in clinical trials for treating ovarian cancer. It works by targeting a specific protein called folate receptor alpha that is found on the surface of many ovarian cancer cells, delivering a cell-killing substance directly to the cancer while sparing healthy cells. The medication is being tested in combination with other treatments to find the safest and most effective dose for patients with ovarian cancer that has high levels of this folate receptor protein.

Investigated diseases

Ovarian Cancer – Ovarian cancer is a disease that occurs when abnormal cells in the ovaries begin to grow and multiply in an uncontrolled manner. The ovaries are reproductive organs located on either side of the uterus that produce eggs and female hormones. As the cancer develops, these abnormal cells form tumors that can interfere with normal ovarian function. The disease often begins without noticeable symptoms in its early stages, which makes it difficult to detect initially. As it progresses, the cancer may spread beyond the ovaries to other parts of the abdomen and pelvis. In advanced stages, the cancerous cells can affect surrounding organs and tissues, causing various complications related to their normal functioning.