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RecruitingPHASE2INTERVENTIONAL

A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine

This research study is investigating a new medication called Mirvetuximab Soravtansine for women with advanced ovarian, peritoneal, or fallopian tube cancers. These are cancers that have not responded well to standard platinum-based chemotherapy. The new drug works by targeting a specific protein (folate receptor alpha) often found on these cancer cells, delivering a cancer-killing medicine directly to them. Researchers want to understand how safe the drug is and how well it works to control the cancer. The study will involve around 110 participants worldwide and will last approximately two years. It's a chance to explore a different treatment option for this type of cancer.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
AbbVie
Enrolment target
110
Start
28 May 2025
Estimated completion
01 Apr 2028

What is this study about?

This study is about a new approach to treating advanced cancers that start in the ovaries, peritoneum (the lining of your tummy), or fallopian tubes. These particular cancers are sometimes called 'high-grade epithelial' and have been resistant to common chemotherapy treatments, specifically those containing platinum.

The new medicine being tested is called Mirvetuximab Soravtansine. Think of it like a guided missile: it has a 'homing' part that specifically looks for a protein called 'folate receptor alpha' (FRα) that can be found on some cancer cells. Once it finds these cells, it delivers a powerful cancer-killing drug directly to them, trying to limit harm to healthy cells. The study aims to see if this targeted treatment is safe and effective in shrinking these cancers or stopping them from growing.

Researchers will also look at different ways to give the new medicine, trying to find the best schedule. Another part of the study will help understand how the drug works in people who might have some liver problems. Overall, this research is an important step in finding new and potentially better ways to treat these challenging cancers.

Key takeaways

  • This study is for advanced ovarian, peritoneal, or fallopian tube cancer that is resistant to common treatments.
  • The new drug, Mirvetuximab Soravtansine, uses a 'homing device' to target specific cancer cells.
  • The main goals are to see how safe and effective the new drug is.
  • Participation involves regular hospital visits, frequent tests, and IV administration of the drug.
  • The study lasts approximately two years and will enrol about 110 participants globally.

Who may be eligible?

To join this study, you would need to have a confirmed diagnosis of advanced high-grade ovarian, primary peritoneal, or fallopian tube cancer. Crucially, your cancer must also have been resistant to previous platinum-based chemotherapy treatments. This means your cancer either started growing again relatively soon after treatment, or didn't respond adequately.

Your cancer cells also need to have a high amount of a specific protein called Folate Receptor Alpha (FRα). Doctors will check for this with a special test on your tumor tissue. You should also generally be well enough to take part in a study like this, as assessed by your doctor, and have at least one measurable tumor that can be tracked during the study.

Hover, you would not be able to join if you have certain other types of ovarian cancer (like endometrioid, clear cell, or mucinous) or if your cancer never responded to your first platinum chemotherapy. Certain serious health conditions or a recent stroke would also prevent you from participating.

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. Do I have advanced ovarian, primary peritoneal, or fallopian tube cancer that has been confirmed by doctors?
  2. Has my cancer not responded well to previous platinum-based chemotherapy treatments?
  3. Does my tumor show high levels of the 'Folate Receptor Alpha' (FRα) protein?
  4. Am I generally well enough to participate in a clinical study?
  5. Do I have at least one tumor that can be accurately measured and tracked?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve regular visits to a hospital or clinic over approximately two years. During these visits, you will have frequent medical check-ups, which may include physical exams, blood tests, and scans (like CT or MRI scans) to monitor your health and how the treatment is affecting your cancer. You would receive the study medication, Mirvetuximab Soravtansine, through a drip into your vein (intravenously).

There are two main groups in the study. In one group, you would receive the medication on a specific schedule, either once every three weeks or twice every four weeks. The other group looks at how the drug works for people with certain liver conditions. It's important to know that taking part in a study often means more appointments and tests than your usual care, but this helps the doctors monitor your health very closely. You will be fully informed about the specific schedule and what to expect before you agree to join.

Potential risks and benefits

Participating in a clinical trial like this comes with potential benefits and risks. A potential benefit is access to a new treatment, Mirvetuximab Soravtansine, which might help control your cancer where standard treatments haven't been as effective. However, there's no guarantee that the new drug will work for you, and it could also have side effects, which the medical team will monitor closely. You might also have more hospital visits and tests than you would with standard care. It's very important to remember that joining is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (52)

  • First Physicians Group /ID# 272180
    Verified postcode
    Sarasota, United States· Recruiting
  • St. Elizabeth Medical Center - Edgewood /ID# 272113
    Verified postcode
    Edgewood, United States· Recruiting
  • Baptist Health Lexington /ID# 272211
    Verified postcode
    Lexington, United States· Recruiting
  • UMass Memorial Medical Center - Belmont Street /ID# 272122
    Verified postcode
    Worcester, United States· Recruiting
  • Karmanos Cancer Institute - Detroit /ID# 272112
    Verified postcode
    Detroit, United States· Recruiting
  • Allegheny Health Network West Penn Hospital /ID# 272267
    Verified postcode
    Pittsburgh, United States· Recruiting
  • Memorial Hermann Texas Medical Center /ID# 272227
    Verified postcode
    Houston, United States· Recruiting
  • Blacktown Hospital /ID# 272182
    Verified postcode
    Blacktown, Australia· Recruiting
  • Newcastle Private Hosptial /ID# 272213
    City only
    Lambton Heights, Australia· Recruiting
  • Royal Brisbane and Women's Hospital /ID# 272123
    Verified postcode
    Brisbane, Australia· Recruiting
  • Icon Cancer Centre Chermside /ID# 272220
    Verified postcode
    Chermside, Australia· Recruiting
  • Ballarat Base Hospital /ID# 272240
    Verified postcode
    Ballarat, Australia· Recruiting

Common questions

What kind of cancer is this study for?

This study is for advanced ovarian, primary peritoneal (lining of the tummy), or fallopian tube cancers that have not responded well to previous treatments.

What is Mirvetuximab Soravtansine?

It's a new medicine that specifically targets a protein on some cancer cells (Folate Receptor Alpha) to deliver a cancer-killing drug directly to them.

How long will the study last?

The study is expected to last about two years in total.

Will I have more doctor visits if I join?

Yes, taking part usually means more regular visits, blood tests, and scans than your usual care, so doctors can closely monitor your health and the treatment.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your future medical care.

How to find out more

ABBVIE CALL CENTER

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Assess Adverse Events and Change in Disease Activ…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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