Study of Mirvetuximab Soravtansine compared to standard chemotherapy in women with platinum-resistant advanced ovarian cancer with high folate receptor expression

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What is this study about?

This study focuses on treating patients with platinum-resistant advanced high-grade epithelial ovarian cancer, primary peritoneal cancer, and fallopian tube cancer that show high levels of a protein called folate receptor-alpha. The main treatment being tested is mirvetuximab soravtansine, a medication that specifically targets cancer cells with high levels of folate receptor-alpha. This treatment will be compared to standard chemotherapy options chosen by doctors, which include topotecan, paclitaxel, or doxorubicin.

The study is designed to determine if mirvetuximab soravtansine works better than standard chemotherapy treatments. The main goal is to measure how long patients live without their cancer getting worse. The study will also look at how well patients respond to treatment, overall survival time, quality of life, and any side effects that may occur.

Participants will be randomly assigned to receive either mirvetuximab soravtansine or one of the standard chemotherapy medications through intravenous infusion. The treatment will continue for several months, with regular check-ups to monitor the cancer’s response to treatment and any side effects. The study is expected to run until mid-2025.

1 Initial evaluation

Your medical condition will be confirmed as platinum-resistant advanced ovarian, peritoneal, or fallopian tube cancer with high folate receptor-alpha expression

A tissue sample analysis will be performed to confirm the presence of specific markers in your tumor

Your overall health status must show adequate blood cell counts, liver, and kidney function

2 Treatment assignment

You will be randomly assigned to receive either mirvetuximab soravtansine or a standard chemotherapy treatment chosen by your doctor

The standard chemotherapy options may include paclitaxel, topotecan, or doxorubicin

3 Treatment administration

Your assigned medication will be given through an intravenous infusion

Regular assessments will monitor how your cancer responds to treatment

Blood tests and imaging scans will be performed to track your progress

4 Monitoring period

Your health status will be regularly evaluated throughout the study

The medical team will monitor any side effects

Imaging scans will be performed to assess if the cancer has grown or spread

Quality of life assessments will be conducted, particularly focusing on abdominal symptoms

5 Follow-up phase

After completing treatment, you will continue to be monitored for any long-term effects

Regular check-ups will track your overall health status

The study will continue until July 2025

Who Can Join the Study?

  • Must be a female aged 18 years or older
  • Must wait appropriate time after previous treatments:
    – At least 4 weeks (or 5 half-lives) after last cancer therapy
    – At least 2 weeks after radiation therapy
    – At least 4 weeks after major surgery
  • Must have recovered from side effects of previous treatments (only mild symptoms or return to initial state)
  • Must have adequate blood test results showing:
    – Sufficient white blood cells
    – Sufficient platelets
    – Adequate hemoglobin levels
    – Normal kidney function
    – Normal liver function
    – Normal bilirubin levels
    – Adequate albumin levels
  • Must be able to understand and sign the consent form
  • If able to become pregnant, must agree to use effective birth control during the study and for 3-6 months after treatment ends
  • Must have a negative pregnancy test within 4 days before starting treatment
  • Must have confirmed high-grade ovarian, peritoneal, or fallopian tube cancer
  • Must have cancer that has become resistant to platinum-based chemotherapy within 6 months after treatment
  • Must show cancer progression on most recent scans
  • Must provide tumor tissue sample or agree to biopsy for testing
  • Must have tumor that tests positive for folate receptor-alpha
  • Must have at least one tumor that can be measured on scans
  • Must have received 1-3 previous cancer treatments
  • Must be able to perform daily activities with minimal assistance (ECOG score of 0 or 1)

Who Cannot Join the Study?

  • Prior treatment with mirvetuximab soravtansine or any other folate receptor-targeted therapy
  • History of other cancer within 3 years before starting the study (except successfully treated non-melanoma skin cancer or cervical cancer in situ)
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Severe heart conditions, including:
    • Heart failure with symptoms
    • Unstable heart rhythm problems
    • Heart attack within the last 6 months
  • Serious active infections requiring treatment
  • Known allergies to the study medications
  • Pregnancy or breastfeeding
  • Unable to use effective birth control methods during the study and for 4 months after
  • Severe liver problems
  • Severe kidney problems
  • Any medical condition that, in the doctor’s opinion, would make it unsafe to participate in the study
  • Unable to understand or sign the informed consent form
  • Current participation in another clinical trial with experimental treatments

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France

Other Sites

Site Name City Country Status
Hopital Prive Des Cotes D’armor Plerin France
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Cnoctc Lqbz Byhkhw Lyon France
Bbkwomtt Uftpuwxidf Hyjdborg Cvxmfd Besançon France
Igvkatem Plcnthfojifugju Cgjjjc Cplzky Marseille France
Clqblf Ozznw Lizvuoq Lille France
Iykmhxfd Cgvsx Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
27.07.2020

Trial locations

Mirvetuximab Soravtansine is a targeted cancer medication designed to treat ovarian, peritoneal, and fallopian tube cancers. It works by specifically targeting cancer cells that have high levels of a protein called folate receptor-alpha on their surface. This medication delivers anti-cancer agents directly to the tumor cells while aiming to minimize damage to healthy cells.

Investigator’s Choice of Chemotherapy refers to standard chemotherapy treatments that doctors can select based on what they believe will work best for individual patients. These are conventional cancer treatments that work by killing rapidly dividing cells throughout the body.

Both treatments are used in patients whose cancer has become resistant to platinum-based chemotherapy treatments, but they work in different ways. While mirvetuximab soravtansine targets specific cancer cells, standard chemotherapy affects all rapidly growing cells in the body.

Ovarian Cancer – A disease that begins in the ovaries, which are part of the female reproductive system. The cancer develops when abnormal cells in the ovaries start to multiply uncontrollably and form tumors. It typically spreads first within the pelvis and abdomen.

Primary Peritoneal Cancer – A rare cancer that develops in the peritoneum, which is the thin, delicate lining that covers the inside wall of the abdomen and most of the organs within it. The cancer cells grow and spread along the surfaces of the peritoneal cavity. This cancer behaves similarly to ovarian cancer.

Fallopian Tube Cancer – A cancer that develops in the fallopian tubes, which are the ducts that connect the ovaries to the uterus. The cancer begins when cells in the fallopian tubes develop mutations and grow out of control. The disease process is very similar to ovarian cancer in terms of how it develops and spreads.

Trial ID:
2024-516111-25-00
Protocol code:
IMGN853-0416
NCT ID:
NCT04209855
Trial Phase:
Therapeutic confirmatory (Phase III)

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