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Active not recruitingPHASE3INTERVENTIONAL

Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

This research study, called GLORIOSA, is for women with specific types of ovarian, fallopian tube, or peritoneal cancer that have come back after their first treatment, but still respond well to chemotherapy. The study aims to find out if adding a new drug, mirvetuximab soravtansine, to an existing treatment called bevacizumab, works better at keeping the cancer from growing or coming back, compared to using bevacizumab alone. Mirvetuximab soravtansine is designed to target and kill cancer cells that have a specific marker called folate receptor alpha (FRα). We want to see if this new combination treatment is safe and effective as a 'maintenance' therapy, meaning it's given after chemotherapy to help prevent the cancer from returning.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
AbbVie
Enrolment target
520
Start
15 Mar 2023
Estimated completion
01 May 2032

What is this study about?

This study is for women who have had ovarian, fallopian tube, or peritoneal cancer that has come back since their first treatment. It's specifically for cancers that still respond well to platinum-based chemotherapy, which doctors call "platinum-sensitive." The study focuses on cancers that show high levels of a specific protein on their surface, called folate receptor alpha (FRα). This protein acts like a target.

The main goal of the study is to test a new medicine called mirvetuximab soravtansine. This medicine is special because it's an "antibody-drug conjugate." Think of it like a guided missile: the "antibody" part is trained to find and attach to the FRα protein on cancer cells. Once it attaches, it delivers a powerful anti-cancer drug directly to those cells, hopefully killing them while causing less harm to healthy cells. This new drug is being tested as a "maintenance therapy," which means it's given after initial treatments to help keep the cancer from growing or returning.

In this study, some women will receive mirvetuximab soravtansine along with another commonly used cancer drug called bevacizumab. Other women will receive bevacizumab on its own. By comparing these two groups, researchers hope to learn if adding mirvetuximab soravtansine helps to control the cancer for longer and if it's safe for patients.

Key takeaways

  • This study is testing a new combination treatment for specific types of recurrent ovarian, fallopian tube, or peritoneal cancer.
  • It's for cancers that are 'platinum-sensitive' and have high levels of a protein called FRα.
  • The new drug, mirvetuximab soravtansine, targets cancer cells with this specific protein.
  • Participants will receive either the new combination or an existing treatment (bevacizumab alone).
  • The goal is to see if the new treatment helps keep the cancer away for longer.
  • Regular hospital visits and health monitoring will be part of taking part.

Who may be eligible?

This study is specifically looking for women aged 18 or older who have been diagnosed with a certain type of ovarian, fallopian tube, or peritoneal cancer (referred to as high-grade serous). Your cancer must have come back after your first round of chemotherapy, but critically, it should still respond well to platinum-based chemotherapy. A crucial part of joining this study is that your cancer cells must show high levels of a specific protein called folate receptor alpha (FRα), which will be checked with a special test.

There are also some important reasons why you might not be able to join. For example, if your cancer is a different type (like endometrioid or clear cell), or if you've already had many rounds of chemotherapy before or developed certain side effects like severe nerve damage. You also can't join if you have certain eye problems, severe blood clots, or if you are pregnant or breastfeeding. The study also needs to ensure that the bevacizumab treatment is suitable for you.

We would also need to confirm that you haven't received specific previous treatments, like mirvetuximab soravtansine or other targeted FRα drugs, and that you don't have certain other medical conditions, including untreated brain tumours or recent history of other cancers. You must also be willing to use effective contraception if you are able to become pregnant.

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.

  1. Are you an adult woman, 18 years or older?
  2. Do you have high-grade serous ovarian, fallopian tube, or peritoneal cancer?
  3. Has your cancer returned after your first chemotherapy and is it still sensitive to platinum-based treatment?
  4. Has your cancer been tested and confirmed to have high levels of the FRα protein?
  5. Are you able and willing to follow all study requirements, including using effective contraception if needed?
  6. Do you have certain medical conditions or past treatments that might prevent you from joining (your doctor can help check this)?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be assigned to one of two groups. One group will receive mirvetuximab soravtansine plus bevacizumab, and the other group will receive bevacizumab alone. Both medicines are given through an IV (into a vein).

You will have regular hospital visits for treatments, check-ups, and tests like blood work, scans (to monitor your cancer), and physical exams. The exact schedule will depend on which group you are in and how you respond to the treatment. These visits are important for the research team to monitor your health and the effects of the treatment.

The total length of time you participate in the study will vary. You will continue treatment for as long as it is benefiting you and you are tolerating the study drugs well, or until your cancer starts to grow again. After your treatment ends, there will be follow-up appointments to check on your long-term health.

Throughout the study, you'll be asked to provide informed consent, which means you understand what's involved and agree to take part. Researchers will be available to answer any questions you have at any time.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. You might benefit from a new treatment option that could help control your cancer for longer than standard therapies. However, there's no guarantee the treatment will work for you, and you may experience side effects. It's important to understand that the new drug, mirvetuximab soravtansine, is still being tested, so its full range of side effects might not be completely known. Bevacizumab, the other drug, also has known side effects which your doctor will discuss with you. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (264)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Usa Mitchell Cancer Institute /ID# 269661
    Verified postcode
    Mobile, United States
  • Honorhealth Virginia G. Piper Cancer Care Network - Biltmore /ID# 269987
    Verified postcode
    Phoenix, United States
  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 269573
    Verified postcode
    Irvine, United States
  • Moores Cancer Center at UC San Diego /ID# 269564
    Verified postcode
    La Jolla, United States
  • Kaiser Permanente - Los Angeles Medical Center /ID# 269541
    Verified postcode
    Los Angeles, United States
  • University Of California Irvine Medical Center /ID# 269572
    Verified postcode
    Orange, United States
  • Stanford Women'S Cancer Center /ID# 269552
    Verified postcode
    Palo Alto, United States
  • Kaiser Permanente - Riverside Medical Center /ID# 269539
    Verified postcode
    Riverside, United States
  • Kaiser Permanente Zion Medical Center /ID# 269537
    Verified postcode
    San Diego, United States
  • Kaiser Permanente - San Diego Medical Center /ID# 269540
    Verified postcode
    San Diego, United States
  • Kaiser Permanente - San Marcos Medical Offices /ID# 269542
    Verified postcode
    San Marcos, United States
  • Olive View-Ucla Medical Center /ID# 269584
    Verified postcode
    Sylmar, United States

Common questions

What is 'maintenance therapy'?

Maintenance therapy is treatment given after initial cancer treatments to help keep the cancer from coming back or to control its growth for a longer time.

What is folate receptor alpha (FRα)?

FRα is a specific protein that can be found on the surface of some cancer cells, including certain types of ovarian cancer. It acts like a marker that the new drug is designed to target.

What are bevacizumab and mirvetuximab soravtansine?

Bevacizumab is a commonly used cancer drug. Mirvetuximab soravtansine is a new investigational drug that targets FRα-positive cancer cells by delivering medicine directly to them.

Will I know which treatment I am getting?

Yes, this is an "open-label" study, meaning both you and your study doctor will know which treatment you are receiving.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point, and this will not affect your usual medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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