Randomized multicenter open-label phase 3 study of mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with FRa-positive recurrent platinum-sensitive ovarian cancer

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Ovarian, Peritoneal, Fallopian Tube Cancers
  • Age: Between 18 Year(s) - 100 Year(s)
  • Gender: Female
  • Other Inclusion Criteria:
      In order to participate in this study the following criteria must be met:
    1. Patients must have a confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. Patients must be willing to provide an archival tumor tissue block or slides, or must undergo a procedure to obtain a new biopsy using a low-risk, medically routine procedure for IHC confirmation of FRa positivity as defined by the Ventana FOLR1 Assay. Patients must be confirmed FRa-high as defined by FRa positivity of = 75% of tumor membrane staining at = 2+ intensity (PS2+) for entry into the study. Prior BRCA testing on the tumor or prior germline testing is required for eligibility. If not done prior, tumor or germline testing will need to be done at study entry. Somatic and germline BRCA-positive patients must have received prior treatment with a PARPi in maintenance following first-line treatment.
    2. Patients must have relapsed after 1 line (first line) of platinum-based chemotherapy and have platinum-sensitive disease defined as progression greater than 6 months from last dose of primary platinum therapy. Patients must be appropriate for, currently be on, or have completed platinum-based triplet therapy. After completion of triplet therapy and before randomization, patients must meet one of the following criteria:
    3. Have at least 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the investigator), and determined by the investigator to either have SD or a PR to their treatment; or
    4. Have persistently elevated CA-125 without measurable disease and determined by the investigator to either have SD or a PR to their treatment; or
    5. Patients must have completed any major surgery at least 4 weeks before the first dose of maintenance treatment and have recovered or stabilized from the side effects of prior surgery before the first dose of maintenance treatment on study.
    6. Patients must have adequate hematologic, liver, and kidney functions defined as follows:
    7. Absolute neutrophil count (ANC) = 1.5 × 109/L (1500/µL) without granulocyte colony-stimulating factor in the prior 10 days or long-acting white blood cell (WBC) growth factors in the prior 10 days of C1D1 of maintenance treatment.
    8. Platelet count = 100 × 109/L (100,000/µL) without platelet transfusion in the prior 10 days of C1D1 of maintenance treatment
    9. Hemoglobin = 9.0 g/dL without packed red blood cell (PRBC) transfusion in the prior 10 days of C1D1 of maintenance treatment

You may not be eligible for this study if the following are true:

    1. You will not be able to participate in this study if you have had:
    2. Patients with endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the above histologies; or low-grade/borderline ovarian tumor. Patients with more than one line of prior chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:
    3. Neoadjuvant ± adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens.
    4. Maintenance therapy (eg, bevacizumab, PARPi) will be considered part of the preceding line of therapy (ie, not counted independently).
    5. Patients who receive an intervening dose of bevacizumab after the last dose of triplet therapy before randomization
    6. Patients with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and/or monocular vision
    7. Patients with serious concurrent illness or clinically relevant active infection, including but not limited to the following:
    8. Active hepatitis B or C infection (whether or not on active antiviral therapy)
    9. HIV infection
    10. Patients with clinically significant cardiac disease

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