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Study of mirvetuximab soravtansine dosing schedules for patients with platinum-resistant advanced ovarian, peritoneal, or fallopian tube 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 patients with platinum-resistant advanced high-grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. The research evaluates a medication called mirvetuximab soravtansine, which is given as a solution through intravenous infusion. The study aims to test different dosing schedules of this medication to determine which one works best while causing the least side effects.

The study involves two main groups of patients. The first group will receive the medication according to different dosing schedules, while patients with moderate liver problems will be studied separately to find the right starting dose for them. During treatment, patients will receive the medication every three weeks as part of a 21-day cycle. The study will also use prednisolone acetate eye drops and lubricating eye drops as supportive care.

The research team will monitor patients for treatment effectiveness and any side effects, particularly paying attention to eye-related effects. They will track how the cancer responds to treatment through regular medical examinations and imaging tests. The study will also measure how long the treatment keeps working and how long patients survive after starting the treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    You will undergo evaluation to confirm that your tumor is positive for FRα expression using a special test (Ventana FOLR1 assay)

    Your doctor will check if you have measurable tumors using imaging scans

    Laboratory tests will be performed to check your blood counts, liver, and kidney function

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two treatment schedules with mirvetuximab soravtansine

    The medication will be given through an intravenous infusion

    The standard dose is 6 mg/kg given once every 3 weeks in a 21-day cycle

  3. Step 3

    Treatment period

    You will receive the medication through an intravenous infusion according to your assigned schedule

    Regular monitoring of your condition will include blood tests and imaging scans

    Your doctor will check for any side effects, particularly those affecting your eyes

    Treatment will continue as long as it is beneficial and you do not experience serious side effects

  4. Step 4

    Follow-up assessments

    Regular scans will be performed to measure how your tumors are responding to treatment

    Blood tests will include monitoring of CA-125 tumor marker levels

    Your doctor will monitor your overall health and any side effects throughout the study

    The study is expected to continue until March 2028

Who can join the trial?

17 criteria

  • Must be 18 years or older
  • Must be female with confirmed diagnosis of high-grade ovarian, peritoneal, or fallopian tube cancer
  • Must have disease that has progressed (gotten worse) after most recent treatment, confirmed by imaging
  • Must have received 1-3 previous cancer treatments
  • Must be willing to provide tumor tissue sample or undergo a biopsy procedure
  • Must have tumors that test positive for a specific protein called FRα at required levels
  • Must have at least one tumor that can be measured by imaging scans
  • Must have good physical function status (ECOG score of 0 or 1, meaning able to perform daily activities)
  • Must have adequate blood cell counts, liver function, and kidney function
  • Must have completed previous cancer treatments within specific timeframes:
    • At least 4 weeks since last cancer medication
    • At least 2 weeks since last radiation treatment
    • At least 4 weeks since major surgery
    • Must have recovered from side effects of previous treatments
    • If able to become pregnant, must:
      • Use effective birth control during study and for 7 months after
      • Have negative pregnancy test within 4 days before starting treatment
      • Must be willing and able to provide informed consent
      • Must have cancer that has become resistant to platinum-based chemotherapy within specific timeframes

Who cannot join the trial?

8 criteria

  • Male patients (study is only for female participants)
  • Patients under 18 years of age
  • Patients with severe liver problems (the study only accepts patients with moderate liver impairment)
  • Patients who have not previously received platinum-based chemotherapy (a type of cancer treatment)
  • Patients who do not have high-grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that is resistant to platinum treatment
  • Patients who are part of vulnerable populations (such as persons with mental disabilities, prisoners, or other protected groups)
  • Patients who cannot receive the study medication every 3 weeks according to the prescribed schedule
  • Patients who cannot be accurately weighed to determine the correct medication dose
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Investigated drugs

Mirvetuximab soravtansine is a medication used to treat patients with certain types of ovarian, peritoneal, or fallopian tube cancers. It specifically targets cancer cells that have high levels of a protein called folate receptor-alpha on their surface. This medication works by delivering an anti-cancer drug directly to these cancer cells, which helps to destroy them while potentially reducing effects on healthy cells. The medication is given through an intravenous infusion (IV drip into a vein).

What is already known about the treatment

Mirvetuximab soravtansine - An antibody-drug conjugate administered intravenously every 3 weeks at a dose of 6 mg/kg based on adjusted ideal body weight for the treatment of platinum-resistant advanced ovarian, peritoneal, and fallopian tube cancers with high folate receptor-alpha expression. This targeted therapy combines an anti-folate receptor alpha antibody with a potent cytotoxic agent, specifically designed to deliver the cancer-fighting drug directly to tumor cells while minimizing damage to healthy tissues. The medication works by binding to folate receptors on cancer cells, followed by internalization and release of the toxic payload, leading to cancer cell death through disruption of cellular microtubules. It represents a significant advancement in targeted therapy for patients who have developed resistance to platinum-based treatments.

Investigated diseases

  • Epithelial Ovarian Cancer

    A cancer that begins in the cells that cover the ovaries. It starts in the outer layer of the ovaries and can spread to nearby tissues. The disease typically develops gradually, with cancer cells multiplying and forming tumors in the ovaries.

  • Primary Peritoneal Cancer

    A rare cancer that forms in the peritoneum, the thin layer of tissue that lines the inside of the abdomen. It develops in the cells of the peritoneum and shares many similarities with ovarian cancer. The cancer can spread throughout the abdominal cavity.

  • Fallopian Tube Cancer

    A cancer that develops in the fallopian tubes, which connect the ovaries to the uterus. The cancer begins in the cells lining the fallopian tubes. It can grow within the tubes and spread to nearby organs.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517184-23-00Protocol codeIMGN853-0425Estimated enrolment111 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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).