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
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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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