All studies
Active not recruitingPHASE2INTERVENTIONAL

Mirvetuximab Soravtansine (MIRV) With Carboplatin in Second-line Treatment of Folate Receptor Alpha (FRα) Expressing, Platinum-sensitive Epithelial Ovarian Cancer

This research study is investigating a new treatment called mirvetuximab soravtansine when given alongside carboplatin for women with specific types of advanced ovarian, primary peritoneal, or fallopian tube cancer. This treatment is for those whose cancer has returned but is considered 'platinum-sensitive,' meaning it responded well to their previous platinum-based chemotherapy. The study focuses on cancers that have a special marker called Folate Receptor Alpha (FRα). Participants will receive the combination treatment for a period, and if their cancer doesn't worsen, they will continue with mirvetuximab soravtansine alone. The main goal is to see how well this new combination works and if it's safe.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
AbbVie
Enrolment target
125
Start
28 Sep 2022
Estimated completion
01 Nov 2026

What is this study about?

This study is testing a new way to treat certain advanced cancers that affect the ovaries, the lining of the abdomen (primary peritoneal cancer), or the fallopian tubes. These are cancers that have come back after a first round of chemotherapy that included a drug called platinum. Crucially, the cancer needs to be 'platinum-sensitive,' which means it responded well to the previous platinum treatment and stayed away for at least six months.

The new treatment being studied involves a drug called mirvetuximab soravtansine, which is given along with carboplatin, a standard chemotherapy drug. Mirvetuximab soravtansine is designed to target a specific protein called Folate Receptor Alpha (FRα) that can be found on the surface of some cancer cells. The idea is that by targeting this protein, the new drug can deliver treatment directly to the cancer cells, potentially leading to fewer side effects on healthy cells.

The study will first involve a combination of both drugs, mirvetuximab soravtansine and carboplatin, for a set number of treatment cycles. If the cancer doesn't get worse during this time, participants will then continue to receive mirvetuximab soravtansine on its own. Researchers want to understand how effective this treatment approach is at controlling the cancer and also to check for any side effects.

Key takeaways

  • Tests a new drug (mirvetuximab soravtansine) with standard chemotherapy (carboplatin).
  • For specific advanced ovarian, primary peritoneal, or fallopian tube cancers.
  • Only for 'platinum-sensitive' cancers with a FRα marker.
  • Participation involves regular clinic visits, blood tests, and scans.
  • Potential for new treatment access, but also risks of side effects.
  • You can stop participating at any time.

Who may be eligible?

To be considered for this study, you must be 18 years or older with a confirmed diagnosis of high-grade ovarian, primary peritoneal, or fallopian tube cancer. Your cancer must have returned after one previous course of platinum-based chemotherapy, and critically, it needs to be 'platinum-sensitive.' This means your cancer did not grow back for at least six months after your last platinum-based treatment.

Another important requirement is that your cancer cells must show a certain level of a marker called Folate Receptor Alpha (FRα). This will be checked using a tissue sample from your cancer. If you have a specific genetic change (BRCA mutation), you generally need to have tried a type of drug called a PARP inhibitor unless your doctor says you absolutely cannot take it.

You should generally be feeling well enough to participate, with a good level of physical activity. Any side effects from your previous treatments should have mostly cleared up, and you must have some cancer that can be measured by scans.

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 18 years or older?
  2. Do you have high-grade ovarian, primary peritoneal, or fallopian tube cancer?
  3. Has your cancer come back after only one previous platinum-based chemotherapy?
  4. Did your cancer stay away for at least 6 months after your last platinum treatment?
  5. Are you generally feeling well enough to participate in daily activities?
  6. Are you willing to provide a tissue sample to check for the FRα marker?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first undergo several tests to make sure you meet all the criteria, including providing a tissue sample to check for the FRα marker. If eligible, you would start treatment with both mirvetuximab soravtansine and carboplatin. This combination would typically be given for up to six cycles. During this period, you would have regular hospital visits for infusions, blood tests, and scans to monitor your health and how the treatment is working. If the treatment is helping and your cancer isn't getting worse after these six cycles, you would then continue to receive mirvetuximab soravtansine on its own.

Throughout your participation, you would have regular check-ups, which would involve physical examinations, blood tests, and imaging scans (like CT scans) to track your progress and manage any side effects. The total length of your participation would depend on how your body responds to the treatment and whether your cancer stays stable, but it could last for many months as long as the treatment is beneficial and you are tolerating it well.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and potential risks. A potential benefit could be access to a new treatment that might be more effective or have different side effects compared to standard options. However, there's no guarantee the treatment will work for you, and it might not be better than existing treatments. Like all medications, the study drugs, mirvetuximab soravtansine and carboplatin, can cause side effects. These could range from mild to serious, and the study team will monitor you closely for any issues. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (69)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Arizona Cancer Center /ID# 268906
    Verified postcode
    Tucson, United States
  • Women'S Cancer Research Network - Cogi /ID# 268912
    Verified postcode
    Fresno, United States
  • Providence - St. Jude Medical /ID# 268911
    Verified postcode
    Fullerton, United States
  • Moores Cancer Center /ID# 268888
    Verified postcode
    La Jolla, United States
  • USC Norris Comprehensive Cancer Center /ID# 268964
    Verified postcode
    Los Angeles, United States
  • University of California Los Angeles Medical Center /ID# 268883
    Verified postcode
    Los Angeles, United States
  • Hoag Memorial Hospital Presbyterian /ID# 268907
    Verified postcode
    Newport Beach, United States
  • UC Davis Comprehensive Cancer Center /ID# 269085
    Verified postcode
    Sacramento, United States
  • Scripps Md Anderson - Prebys Cancer Center /ID# 268966
    Verified postcode
    San Diego, United States
  • California Pacific Medical Center - Van Ness Campus /ID# 268886
    Verified postcode
    San Francisco, United States
  • Smilow Cancer Hospital at Yale New Haven /ID# 268889
    Verified postcode
    New Haven, United States
  • AdventHealth Orlando /ID# 268920
    Verified postcode
    Orlando, United States

Common questions

What is 'platinum-sensitive' cancer?

It means your cancer responded well to previous chemotherapy that included a drug like carboplatin or cisplatin, and it didn't come back for at least six months after that treatment.

What is Folate Receptor Alpha (FRα)?

It's a specific protein that can be found on the surface of some cancer cells. This study treatment is designed to target cancer cells that have this protein.

Will I receive both new and old drugs?

Yes, initially you will receive the new drug, mirvetuximab soravtansine, along with a standard chemotherapy drug, carboplatin. If your cancer responds well, you'll continue with only the new drug.

What if I have BRCA gene changes?

If you have a BRCA mutation, you generally need to have already tried a type of drug called a PARP inhibitor, unless your doctor advises against it for medical reasons.

How long will the treatment take?

The initial combination treatment involves several cycles, after which you would continue with a single drug for as long as it benefits you and you tolerate it well.

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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