Phase 2
N=106
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
Neoplasms, Ovarian
Bottom Line
View on ClinicalTrials.gov: NCT05613088 ↗Enrolled (actual)
106
Serious AEs
31.7%
Results posted
Jul 2025
Primary outcome: Primary: Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment — 20.0; 13.9 Percent of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MORAb-202 (Drug); Paclitaxel (Drug); Pegylated Liposomal Doxorubicin (PLD) (Drug); Topotecan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment |
20.0; 13.9 | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Event (TRAEs) Leading to Discontinuation Within 6 Months From First Dose |
2; 0 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
67; 32 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
19; 10 | — |
| SECONDARY Number of Participants With AEs Leading to Discontinuation |
3; 0 | — |
| SECONDARY Number of Participants With Treatment-Related AEs |
53; 29 | — |
| SECONDARY Number of Participants With Treatment-Related SAEs |
1; 2 | — |
| SECONDARY Number of Participants With AEs of Special Interest (AESIs) |
1; 1; 2; 0; 13; 0 | — |
| SECONDARY Number of Participants Who Died |
21; 6 | — |
| SECONDARY Number of Participants With Grade 3-4 Laboratory Abnormalities |
3; 0; 3; 9 | — |
| SECONDARY Disease Control Rate (DCR) by RECIST v1.1 Per Investigator Assessment |
80.0; 69.4 | — |
| SECONDARY Duration of Response (DoR) by RECIST v1.1 Per Investigator Assessment |
4.42; 5.55 | — |
| SECONDARY Progression-free Survival (PFS) by RECIST v1.1 Per Investigator Assessment |
4.01; 4.40 | 0.4063 |
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.
Data sourced from ClinicalTrials.gov (NCT05613088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.