Inclusion Criteria:
- Female participants with histologically-confirmed diagnosis of HGS ovarian, primary
peritoneal, or fallopian tube cancer.
- Platinum-resistant disease, defined as:
- For participants who had only 1 line of platinum-based therapy: progression between >
1 month and ≤ 6 months after the last dose of platinum-based therapy of at least 4
cycles.
- For participants who had 2 or 3 lines of platinum-based therapy: progression ≤ 6
months after the last dose of platinum-based therapy.
- Participants have received at least 1 but no more than 3 prior lines of systemic
therapy and for whom single-agent therapy is appropriate as the next line of therapy.
Participants may have been treated with up to 1 line of therapy subsequent to
determination of platinum-resistance.
- Disease progression per RECIST v1.1 (by investigator assessment) of at least 1
measurable lesion on or after the most recent therapy.
- Either formalin-fixed, paraffin-embedded (FFPE) tissue (up to 5 years old) or
newly-obtained biopsies must be available for FRα assessment prior to randomization.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
Exclusion Criteria:
Medical Conditions
- Clear cell, mucinous, endometrioid or sarcomatous histology, or mixed tumors
containing components of any of these histologies, or low grade or borderline ovarian
cancer.
- Primary platinum-refractory ovarian cancer defined as disease progression within 1
month of the last dose of the first line platinum-containing regimen.
- Pulmonary function test (PFT) abnormalities: FEV1 < 70% or FVC < 60%, and DLCO < 80%.
- Investigator-assessed current ILD/pneumonitis, or ILD/pneumonitis suspected at
screening or history of ILD/pneumonitis of any severity including ILD/pneumonitis from
prior anti-cancer therapy.
- Significant third-space fluid retention (eg, ascites or pleural effusion) that
requires repeated drainage.
Physical and Laboratory Test Findings
- Evidence of organ dysfunction or any clinically-significant deviation from normal in
physical examination, vital signs, ECG, or clinical laboratory determinations beyond
what is consistent with the target population.
Allergies and Adverse Drug Reactions
- Has any prior severe hypersensitivity (≥ Grade 3) to monoclonal antibodies or eribulin
or contraindication to the receipt of corticosteroids or any of the excipients
(investigators should refer to the prescribing information for the selected
corticosteroid).
- History of allergy or contraindication to IC chemotherapy agent selected if randomized
to Arm C.
Other protocol-defined inclusion/exclusion criteria apply.
Recruiting
