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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

15 criteria

  • 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 trial?

15 criteria

  • 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
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Investigated drugs

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.

What is already known about the treatment

  • Mirvetuximab Soravtansine

    An innovative antibody-drug conjugate administered through intravenous infusion, specifically designed for treating platinum-resistant advanced ovarian, peritoneal, and fallopian tube cancers with high folate receptor-alpha expression. This targeted therapy combines a folate receptor alpha-binding antibody with a potent cytotoxic agent (soravtansine), allowing for precise delivery of the cancer-fighting compound to tumor cells while minimizing damage to healthy tissue. The medication belongs to the class of targeted cancer therapeutics and works by binding to folate receptors on cancer cells, followed by internalization of the drug complex and release of the cytotoxic payload, leading to cancer cell death.

  • Investigator's Choice Chemotherapy

    A treatment approach where the treating physician selects from established chemotherapy options based on individual patient factors and disease characteristics. This conventional treatment method typically involves intravenous administration of standard chemotherapy drugs used in platinum-resistant gynecologic cancers. The medication choice is made from a pre-specified set of approved chemotherapy agents, each working through different mechanisms to prevent cancer cell division and growth.

Investigated diseases

  • 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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516111-25-00Protocol codeIMGN853-0416Estimated enrolment195 patientsSponsorImmunogen Inc.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).