A Phase 2 Study of MORAb-202 in Platinum-resistant High-grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Trial details

Who runs it

Bristol Myers Squibb International Corporation

Trial code

EU 2023-504111-33-00

Record updated

2025. szeptember 8.

Original description

1. To compare objective response rate of MORAb-202 vs Investigator's Choice (IC) chemotherapy (in all randomized participants) 2. To evaluate the proportion of participants with treatment-related adverse events (TRAEs) leading to discontinuation in each arm within 6 months from first dose of study drug administration in all treated participantsRead full original descriptionShow less

A Phase 2 Open-label Randomized Study of Farletuzumab Ecteribulin (MORAb-202), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, vs Investigator's Choice Chemotherapy in Women with Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

1. To compare objective response rate of MORAb-202 vs Investigator's Choice (IC) chemotherapy (in all randomized participants) 2. To evaluate the proportion of participants with treatment-related adverse events (TRAEs) leading to discontinuation in each arm within 6 months from first dose of study drug administration in all treated participants

Inclusion: Participants must be 18 years old or local age of majority at the time of signing the informed consent; 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. - Participants must have received prior treatment with bevacizumab or must be deemed medically inappropriate or ineligible/intolerant to receive bevacizumab, refused to receive bevacizumab, or been unable to receive bevacizumab due to lack of access.NOTES: Neoadjuvant ± adjuvant chemotherapy will be considered 1 line of therapy. Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be considered part of the preceding line of therapy. Therapy changed in the absence of progression will be considered part of the same line; 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 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: Has any prior severe hypersensitivity (≥ Grade 3) to monoclonal antibodies or eribulin or contraindication to the receipt of corticosteroids or any of the excipients; Participants currently in other interventional trials may not participate in BMS clinical trials until the protocol specific washout period is achieved; Prior pneumonectomy. Prior lobectomy and segmentectomy are allowed >12 months before treatment; Recent chest radiotherapy received under 6 months before starting study treatment; Uncontrolled or significant cardiovascular conditions within 6 months prior; Prior treatment with an investigational FRα-targeting agent and FRα-targeting ADC; Clear cell, mucinous, endometrioid or sarcomatous histology, or mixed tumors containing components of any of these histologies, or low grade or borderline ovarian cancer; History of allergy or contraindication to IC chemotherapy agent selected if randomized to Arm C; Any autoimmune, connective tissue, or inflammatory disorders where there is documented (or suspicion of) pulmonary involvement; Uncontrolled medical disorders that, in the opinion of the Investigator or Sponsor, may increase the risk associated with study participation or study drug administration, impair the ability of the participant to receive protocol therapy, or interfere with the interpretation of study results; 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; Inadequate liver function evidenced by abnormal levels of total bilirubin, alkaline phosphatase (ALP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) or serum albumin; Significant third-space fluid retention (eg, ascites or pleural effusion) that requires repeated drainage; Clinically significant pericardial effusion requiring drainage.

EU CTIS 2023-504111-33-00