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Study of Mirvetuximab Soravtansine and Bevacizumab for Maintenance in Adults with Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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What is this trial about?

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

This clinical trial is focused on studying the treatment of platinum-sensitive epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. These are types of cancers that affect the female reproductive system and are sensitive to platinum-based chemotherapy. The study will use a combination of two medications: mirvetuximab soravtansine and bevacizumab. Mirvetuximab soravtansine, also known by its code name IMGN853, is an antibody-drug conjugate, which means it is a targeted therapy designed to bind to specific cancer cells. Bevacizumab is a medication that inhibits the growth of blood vessels that supply nutrients to tumors, helping to slow or stop their growth.

The purpose of this study is to compare the effectiveness of the combination of mirvetuximab soravtansine and bevacizumab with bevacizumab alone in maintaining the health of patients who have not shown disease progression after receiving platinum-based chemotherapy. Patients will be randomly assigned to receive either the combination treatment or bevacizumab alone. The study will monitor the patients over a period to assess how long they remain free from cancer progression. This is known as progression-free survival, which is a measure of how long patients live without the cancer getting worse.

Participants in the study will receive the treatments as an infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will also involve regular check-ups and assessments to monitor the patients' health and any side effects they may experience. The trial aims to provide valuable information on whether the combination of mirvetuximab soravtansine and bevacizumab offers better outcomes for patients compared to bevacizumab alone. This research could potentially lead to improved treatment options for individuals with these types of cancers.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, previous treatments, and health status.

    A consent form is signed to confirm understanding and agreement to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment is conducted, which includes imaging tests like CT or MRI scans and blood tests to measure CA-125 levels.

    This assessment occurs between 3 to 8 weeks after the last dose of previous chemotherapy.

  3. Step 3

    Randomization

    Participants are randomly assigned to one of two groups: one receiving mirvetuximab soravtansine with bevacizumab, and the other receiving bevacizumab alone.

    This step must occur no later than 8 weeks after the last chemotherapy dose.

  4. Step 4

    Treatment phase

    For those in the combination group, mirvetuximab soravtansine and bevacizumab are administered through intravenous infusion.

    The frequency and dosage are determined by the study protocol and monitored by healthcare professionals.

  5. Step 5

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor health status, side effects, and treatment effectiveness.

    These visits include physical exams, blood tests, and imaging studies as needed.

  6. Step 6

    Completion of treatment

    Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the treatment.

    Participants may continue to be monitored for long-term outcomes and any delayed side effects.

Who can join the trial?

19 criteria

  • Patients must be at least 18 years old.
  • Patients must have received or be receiving specific chemotherapy drugs like paclitaxel, gemcitabine, or pegylated liposomal doxorubicin along with platinum-based therapy.
  • Patients must have shown a response to treatment, such as complete response (CR), partial response (PR), or stable disease (SD), after completing the therapy.
  • Patients must be randomized into the study within 8 weeks after their last dose of the platinum-based therapy.
  • Patients must have either measurable disease, elevated CA-125 levels, or no evidence of disease as determined by medical tests.
  • Patients must have recovered from any side effects of previous treatments, except for hair loss.
  • Patients must have completed any major surgery at least 4 weeks before starting the study treatment and have recovered from it.
  • Patients must have adequate blood, liver, and kidney function as defined by specific medical tests.
  • Patients must be willing to sign a consent form and follow the study requirements.
  • Females who can have children must agree to use effective birth control methods during the study and for at least 3 months after the last dose.
  • Females who can have children must have a negative pregnancy test before starting the therapy.
  • Patients must have a performance status of 0 or 1, which means they are fully active or have some restrictions but can still do light work.
  • Patients must have a confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
  • Patients must provide a tumor sample for testing or undergo a procedure to obtain a new biopsy to confirm high levels of a specific protein (FRα).
  • Patients must have had prior BRCA testing, which checks for specific genetic mutations, and have received certain treatments if they tested positive.
  • Patients' disease must have returned after one line of platinum-based chemotherapy and must be sensitive to platinum, meaning it took more than 6 months for the disease to progress after the last dose.
  • Patients must be suitable for, currently on, or have completed platinum-based triplet therapy in the second line of treatment.
  • Patients must have received between 4 to 8 cycles of platinum-based triplet therapy, including at least 3 cycles with bevacizumab, unless stopped due to side effects.
  • In cases of certain surgeries, patients may have received fewer cycles of bevacizumab if given with the last cycles of platinum-based therapy.

Who cannot join the trial?

4 criteria

  • Patients who do not have **platinum-sensitive** cancers. This means the cancer should respond well to treatments that contain a metal called platinum.
  • Patients who do not have **epithelial ovarian, fallopian tube, or primary peritoneal cancers**. These are specific types of cancers that affect the ovaries, the tubes connecting the ovaries to the uterus, or the lining of the abdomen.
  • Patients who are not female, as the study is only for female participants.
  • Patients who are not considered part of a **vulnerable population**. This term refers to groups of people who might need special protection or care.
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Investigated drugs

  • Mirvetuximab Soravtansine

    is an experimental medication being studied for its potential to treat certain types of cancer. It is designed to target and bind to specific cancer cells, delivering a toxic substance directly to them to help destroy the cancer cells while minimizing damage to healthy cells. In this trial, it is being tested in combination with another medication to see if it can help prevent the cancer from coming back or getting worse.

  • Bevacizumab

    is a medication used to treat various types of cancer. It works by blocking a protein that helps cancer cells grow new blood vessels, which are needed for tumors to grow and spread. By inhibiting this protein, bevacizumab can help slow down or stop the growth of cancer. In this trial, it is used both alone and in combination with another medication to see how effective it is in maintaining the health of patients with certain types of ovarian and related cancers.

What is already known about the treatment

  • Mirvetuximab Soravtansine

    This medication is administered intravenously and is currently being studied in clinical trials as a potential treatment for certain types of ovarian, fallopian tube, and peritoneal cancers. It is being evaluated for its effectiveness in combination with bevacizumab as a maintenance therapy. The drug works by targeting and binding to a specific protein on cancer cells, delivering a toxic agent that helps to kill these cells. It is classified as an antibody-drug conjugate, which combines the targeting ability of an antibody with the cancer-killing power of a chemotherapy drug.

  • Bevacizumab

    This medication is also administered intravenously and is already approved for use in various cancer treatments. It is being studied in combination with mirvetuximab soravtansine for its potential to improve outcomes in patients with certain ovarian, fallopian tube, and peritoneal cancers. Bevacizumab works by inhibiting the growth of blood vessels that supply nutrients to tumors, effectively starving the cancer cells. It is classified as an angiogenesis inhibitor, which helps to slow or stop the growth of tumors by blocking the blood supply they need to grow.

Investigated diseases

  • Platinum-sensitive epithelial ovarian cancer

    This type of cancer originates in the epithelial cells of the ovaries and is characterized by its responsiveness to platinum-based chemotherapy. It often recurs after initial treatment but tends to respond well to subsequent rounds of platinum-based drugs. The disease progresses as cancer cells grow and spread within the ovaries and potentially to other areas of the pelvis and abdomen. Symptoms may include abdominal bloating, pelvic pain, and changes in bowel habits. The progression is typically monitored through imaging and tumor marker tests.

  • Platinum-sensitive fallopian tube cancer

    This cancer arises in the epithelial cells lining the fallopian tubes and shares similarities with ovarian cancer in terms of treatment response. It is termed "platinum-sensitive" because it responds to platinum-based chemotherapy, especially after a period of remission. The disease can spread to nearby organs and tissues, leading to symptoms such as pelvic pain and abnormal vaginal bleeding. Monitoring involves regular imaging and clinical evaluations to assess the extent of disease spread.

  • Platinum-sensitive primary peritoneal cancer

    This cancer develops in the peritoneum, a thin layer of tissue lining the abdomen, and is closely related to ovarian cancer. It is considered platinum-sensitive when it responds to platinum-based chemotherapy after initial treatment. The cancer can spread throughout the abdominal cavity, causing symptoms like abdominal pain and swelling. Disease progression is tracked through imaging studies and clinical assessments to evaluate the response to treatment.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-501606-35-01Protocol codeIMGN853-0421Estimated enrolment525 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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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.

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