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

Completed · Phase 2

Conditions studied: Neoplasms, Ovarian

In brief

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.

Key facts

Study ID

NCT05613088

Run by

Bristol-Myers Squibb

People needed

106

Starts

2023-02-01

Expected to finish

2025-09-10

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Local Institution - 0021 — Barcelona, Spain
• Local Institution - 0020 — Girona, Spain
• Local Institution - 0038 — Madrid, Spain
• Local Institution - 0022 — Madrid, Spain
• Local Institution - 0065 — Sacramento, California, United States
• Local Institution - 0025 — San Francisco, California, United States
• Local Institution - 0078 — Whittier, California, United States
• Local Institution - 0081 — South Bend, Indiana, United States
• Local Institution - 0043 — Kansas City, Kansas, United States
• Local Institution - 0023 — Canton, Ohio, United States
• Local Institution - 0061 — Columbus, Ohio, United States
• Local Institution - 0044 — Nashville, Tennessee, United States
• Local Institution - 0082 — Salt Lake City, Utah, United States
• Local Institution - 0042 — Spokane, Washington, United States
• Local Institution - 0016 — Sydney, New South Wales, Australia
• Local Institution - 0017 — Waratah, New South Wales, Australia
• Local Institution - 0031 — Chermside, Queensland, Australia
• Local Institution - 0015 — Clayton, Victoria, Australia
• Local Institution - 0027 — Malvern, Victoria, Australia
• Local Institution - 0058 — Nedlands, Western Australia, Australia
• Local Institution - 0032 — Leuven, VBR, Belgium
• Local Institution - 0013 — Namur, WNA, Belgium
• Local Institution - 0012 — Brussels, Belgium
• Local Institution - 0045 — Liège, Belgium
• Local Institution - 0030 — Santiago, RM, Chile

Full record on ClinicalTrials.gov

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