Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

MIRASOL: A Randomized, Open-label, Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Platinum- Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression

The MIRASOL study is a clinical trial looking at a new treatment called Mirvetuximab Soravtansine for certain advanced cancers. It's for women with advanced ovarian, primary peritoneal, or fallopian tube cancers that have stopped responding to platinum-based chemotherapy. Researchers are particularly interested in cancers with high levels of a specific marker called folate receptor-alpha. This study compares the new drug to standard chemotherapy choices to see which works better at slowing down cancer growth. It's a Phase 3 study, meaning it's in the later stages of testing before a new drug might become widely available. The main goal is to see if the new drug can keep the cancer from growing for a longer time.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Immunogen Inc.

Enrolment target

Start

15 Oct 2024

Platinum-Resistant Advanced High-Grade Epithelial Ovarian Primary Peritoneal or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression

What is this study about?

The MIRASOL study is a major clinical trial exploring a new potential treatment for certain types of advanced cancer. Specifically, it's for women who have advanced ovarian, primary peritoneal (lining of the abdomen), or fallopian tube cancers. These particular cancers are those that have stopped responding to (are "resistant" to) standard platinum-based chemotherapy. On top of that, the study is focused on cancers that have a high amount of something called folate receptor-alpha, which is a specific protein found on the surface of some cancer cells.

In this study, one group of patients will receive the new medicine, Mirvetuximab Soravtansine. Another group will receive one of the standard chemotherapy treatments that doctors would typically use in this situation. The main aim is to see if Mirvetuximab Soravtansine is more effective at slowing down the cancer's growth or shrinking it, compared to the standard treatments. Researchers will carefully track how long it takes for the cancer to grow or for other changes to occur. They'll also look at things like how long people live, how much the cancer shrinks, and quality of life.

This kind of study is really important because it helps scientists understand if new treatments are safe and work better than what's currently available. If a new treatment proves to be effective and safe in a Phase 3 trial like MIRASOL, it could eventually become an option for many more patients in the future. The information gathered will help doctors make better decisions about treatment for advanced ovarian, peritoneal, and fallopian tube cancers.

Key takeaways

Tests a new drug (Mirvetuximab Soravtansine) for advanced ovarian, peritoneal, or fallopian tube cancer.
For cancers that have stopped responding to platinum chemotherapy.
Specifically targets cancers with high folate receptor-alpha protein.
Compares the new drug to standard chemotherapy options.
Aims to see if the new drug can stop cancer growth for longer.
Participation involves regular clinic visits for treatment and monitoring.

Who may be eligible?

This study is specifically designed for women aged 18 and over. You would be considered for this study if you have advanced ovarian, primary peritoneal (cancer of the lining of the abdomen), or fallopian tube cancers.

Importantly, your cancer must have stopped responding to previous platinum-based chemotherapy treatments. This means your cancer has either continued to grow or come back despite receiving these types of medications.

Another key requirement is that your cancer cells must show a high level of something called "folate receptor-alpha." This is a special marker on the cancer cells that the study drug is designed to target.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 18 or older?
Do you have advanced ovarian, primary peritoneal, or fallopian tube cancer?
Has your cancer stopped responding to platinum-based chemotherapy?
Have your cancer cells been tested and found to have high levels of 'folate receptor-alpha'?
Are you able to travel to a study site for regular appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new study drug, Mirvetuximab Soravtansine, or one of several standard chemotherapy medicines. The doctors would choose which standard chemotherapy is best suited for you. You would have regular appointments at the study clinic for your treatments and check-ups.

These visits will involve various tests, such as blood samples, physical examinations, and scans to monitor your cancer and your general health. The study team will be looking closely at how the treatment is working and if you experience any side effects. You'll likely have ongoing follow-up appointments even after your main treatment period to see how you're doing in the long term. The total duration of your participation would depend on how your cancer responds to treatment and how you feel.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available, and close monitoring by medical professionals. This study could also help us learn more about treating advanced ovarian, peritoneal, and fallopian tube cancers. However, there are also potential risks; the new drug may have side effects that are not yet fully known, or it might not work as well as expected. Standard chemotherapy treatments also come with known side effects. It's important to discuss any concerns with the study team. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What does 'Platinum-resistant' mean?

It means your cancer has either grown or come back even after you've received chemotherapy drugs that contain platinum, like cisplatin or carboplatin.

What is 'High Folate Receptor-Alpha Expression'?

This refers to whether your cancer cells have a lot of a specific protein called folate receptor-alpha on their surface. The new study drug is designed to target cells with this protein.

Is Mirvetuximab Soravtansine a type of chemotherapy?

Mirvetuximab Soravtansine is a different type of drug, sometimes called an 'antibody-drug conjugate.' It's designed to specifically deliver chemotherapy directly to cancer cells that have the folate receptor-alpha protein, aiming to reduce harm to healthy cells.

What is a Phase 3 study?

A Phase 3 study is one of the final stages of clinical testing for a new drug. It compares the new treatment to existing standard treatments in a larger group of patients to confirm if it's safe and more effective.

Will I know if I'm getting the new drug or standard chemotherapy?

This study is 'open-label,' which means both you and your doctor will know whether you are receiving the new study drug or one of the standard chemotherapy treatments.