a study of morab-202 versus investigator's choice chemotherapy in female participants with platinum-resistant high-grade serous (hgs) ovarian, primary peritoneal, or fallopian tube cancer

Conditions: Neoplasms, Ovarian

Summary: the purpose of the study is to assess the safety, tolerability, and efficacy of farletuzumab ecteribulin (morab-202) and compare it to investigator's choice (ic) chemotherapy in female participants with platinum-resistant hgs ovarian, primary peritoneal, or fallopian tube cancer.


Eligibility criteria:
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.

Keywords: platinum-resistant ovarian cancer (proc) primary peritoneal cancer fallopian tube cancer morab-202 folate-receptor alpha adc antibody-drug conjugate epithelial ovarian cancer high grade serous farletuzumab ecteribulin