Study Comparing MORAb-202 with Chemotherapy for Women with Platinum-resistant High-grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Sponsor: Bristol-Myers Squibb

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05613088

This clinical trial is evaluating the safety and effectiveness of a new drug, MORAb-202, compared to standard chemotherapy in women with certain types of ovarian, primary peritoneal, or fallopian tube cancer that have not responded to platinum-based treatments.

Patient Parameters

Program Overview

The aim of this study is to determine how safe and effective a new treatment, called farletuzumab ecteribulin (MORAb-202), is compared to the usual chemotherapy chosen by doctors for women with high-grade serous ovarian, primary peritoneal, or fallopian tube cancer that has not responded to platinum-based treatments.

Eligibility Criteria

Inclusion Criteria

  • Women diagnosed with high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
  • Cancer that has not responded to platinum-based treatments, defined as:
    • If only one round of platinum treatment was given, the cancer returned between 1 and 6 months after the last dose.
    • If two or three rounds of platinum treatment were given, the cancer returned within 6 months after the last dose.
  • Have had at least one but no more than three previous treatments, and single-agent therapy is suitable as the next step.
  • Cancer has progressed with at least one measurable tumor after the most recent treatment.
  • Must provide a tissue sample for FRα testing before starting the study.
  • Must be in good general health with an ECOG performance status of 0 or 1.

Exclusion Criteria

  • Have certain types of ovarian cancer, such as clear cell, mucinous, endometrioid, or sarcomatous, or mixed tumors with these types.
  • Cancer that did not respond to the first round of platinum treatment.
  • Have lung function issues, such as low FEV1, FVC, or DLCO.
  • Have or had lung inflammation (ILD/pneumonitis) or are suspected to have it.
  • Have significant fluid buildup in the body that needs frequent draining.
  • Have organ dysfunction or significant abnormalities in physical exams or lab tests.
  • Have severe allergies to monoclonal antibodies, eribulin, or corticosteroids, or any ingredients in the study drugs.
  • Have allergies or contraindications to the chemotherapy chosen for the study.

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