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

April 16, 2026 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2065
        • Local Institution - 0016
      • Waratah, New South Wales, Australia, 2298
        • Local Institution - 0017
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • Local Institution - 0031
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Local Institution - 0015
      • Malvern, Victoria, Australia, 3144
        • Local Institution - 0027
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Local Institution - 0058
  • Belgium
      • Brussels, Belgium, 1200
        • Local Institution - 0012
      • Liège, Belgium, 4000
        • Local Institution - 0045
    • VBR
      • Leuven, VBR, Belgium, 3000
        • Local Institution - 0032
    • WNA
      • Namur, WNA, Belgium, 5000
        • Local Institution - 0013
  • Chile
      • Santiago, Chile, 7510032
        • Local Institution - 0036
      • Temuco, Chile, 4800827
        • Local Institution - 0029
    • RM
      • Santiago, RM, Chile, 8420323
        • Local Institution - 0030
  • Israel
      • Haifa, Israel, 31999
        • Local Institution - 0054
      • Jerusalem, Israel, 91031
        • Local Institution - 0080
      • Ramat Gan, Israel, 5265601
        • Local Institution - 0055
      • Tel Aviv, Israel, 64239
        • Local Institution - 0048
    • JM
      • Jerusaelm, JM, Israel, 9112001
        • Local Institution - 0046
  • Italy
      • Brescia, Italy, 25123
        • Local Institution - 0002
    • BO
      • Bologna, BO, Italy, 40138
        • Local Institution - 0003
    • MI
      • Milan, MI, Italy, 20132
        • Local Institution - 0011
      • Milan, MI, Italy, 20141
        • Local Institution - 0009
    • RM
      • Roma, RM, Italy, 00168
        • Local Institution - 0010
  • Japan
      • Akashi, Hyogo, Japan, 673-8558
        • Local Institution - 0018
      • Chūōku, Japan, 104-0045
        • Local Institution - 0019
      • Hidaka-shi, Japan, 350-1298
        • Local Institution - 0014
      • Kurume-Shi, Japan, 830-0011
        • Local Institution - 0004
      • Tokyo, Japan, 135-8550
        • Local Institution - 0037
  • South Korea
      • Seoul, South Korea, 03080
        • Local Institution - 0056
      • Seoul, South Korea, 03722
        • Local Institution - 0049
      • Seoul, South Korea, 5505
        • Local Institution - 0053
  • Spain
      • Barcelona, Spain, 08036
        • Local Institution - 0021
      • Girona, Spain, 17007
        • Local Institution - 0020
      • Madrid, Spain, 28033
        • Local Institution - 0038
      • Madrid, Spain, 28046
        • Local Institution - 0022
    • B
      • Barcelona, B, Spain, 08035
        • Local Institution - 0039
    • M
      • Madrid, M, Spain, 28041
        • Local Institution - 0001
      • Madrid, M, Spain, 28007
        • Local Institution - 0005
    • V
      • Valencia, V, Spain, 46009
        • Local Institution - 0007
      • Valencia, V, Spain, 46010
        • Local Institution - 0006
  • United States
    • California
      • Sacramento, California, United States, 95817
        • Local Institution - 0065
      • San Francisco, California, United States, 94109
        • Local Institution - 0025
      • Whittier, California, United States, 90602-3171
        • Local Institution - 0078
    • Indiana
      • South Bend, Indiana, United States, 46601-1033
        • Local Institution - 0081
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Local Institution - 0043
    • Ohio
      • Canton, Ohio, United States, 44710-1702
        • Local Institution - 0023
      • Columbus, Ohio, United States, 43219
        • Local Institution - 0061
    • Tennessee
      • Nashville, Tennessee, United States, 37203-1625
        • Local Institution - 0044
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Local Institution - 0082
    • Washington
      • Spokane, Washington, United States, 99204
        • Local Institution - 0042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MORAb-202
Drug: MORAb-202
Specified dose on specified days
Other Names:
  • BMS-986445
  • Farletuzumab Ecteribulin
Experimental: Investigator's Choice Chemotherapy
Drug: Paclitaxel
Specified dose on specified days
Other Names:
  • Bendalis
Drug: Pegylated Liposomal Doxorubicin (PLD)
Specified dose on specified days
Other Names:
  • Caelyx
Drug: Topotecan
Specified dose on specified days
Other Names:
  • Hycamtin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment
Time Frame: From the date of randomization to the date of first objectively-documented progression or the date of subsequent therapy (Up to approximately 70 weeks)

Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on investigator assessments [using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1], divided by the number of all randomized participants.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From the date of randomization to the date of first objectively-documented progression or the date of subsequent therapy (Up to approximately 70 weeks)
Number of Participants With Treatment-Related Adverse Event (TRAEs) Leading to Discontinuation Within 6 Months From First Dose
Time Frame: From first dose of study medication up to 6 months
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.
From first dose of study medication up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.
From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
Number of Participants With AEs Leading to Discontinuation
Time Frame: From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.
From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
Number of Participants With Treatment-Related AEs
Time Frame: From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.
From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
Number of Participants With Treatment-Related SAEs
Time Frame: From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
Number of Participants With AEs of Special Interest (AESIs)
Time Frame: From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.

AEs of special interest include: Infusion-related reactions, Interstitial lung disease (ILD) and Pneumonitis
From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
Number of Participants Who Died
Time Frame: From first dose of study medication until death due to any cause (up to 70 weeks)
Number of participants who died during the study.
From first dose of study medication until death due to any cause (up to 70 weeks)
Number of Participants With Grade 3-4 Laboratory Abnormalities
Time Frame: From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)

Number of participants experiencing clinical abnormalities in laboratory testing including hematology, chemistry, liver function, and renal function.

Laboratory findings are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
Disease Control Rate (DCR) by RECIST v1.1 Per Investigator Assessment
Time Frame: From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 70 weeks)

Disease Control Rate (DCR) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on investigator assessments (using RECIST v1.1) divided by the number of all randomized participants.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).

Based on Clopper and Pearson estimates of duration of response
From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 70 weeks)
Duration of Response (DoR) by RECIST v1.1 Per Investigator Assessment
Time Frame: From the date of first dose to the date of the first documented tumor progression, or death, whichever occurs first (Up to approximately 70 weeks)

Duration of Response (DoR) is defined as the time between the date of first documented response (CR or PR) confirmed, to the date of the first objectively documented tumor progression by investigator (per RECIST v1.1) or death, whichever occurs first.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).

Based on Kaplan-Meier estimates of duration of response
From the date of first dose to the date of the first documented tumor progression, or death, whichever occurs first (Up to approximately 70 weeks)
Progression-free Survival (PFS) by RECIST v1.1 Per Investigator Assessment
Time Frame: From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 70 weeks)

Progression-free Survival (PFS) is defined as the time between the date of randomization and the first date of documented progression, per investigator assessments (using RECIST v1.1), or death due to any cause, whichever occurs first.

Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).

Based on Kaplan-Meier estimates of progression-free survival
From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 70 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Eisai Inc.

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

June 17, 2024

Study Completion (Actual)

September 10, 2025

Study Registration Dates

First Submitted

November 4, 2022

First Submitted That Met QC Criteria

November 4, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA116-001
  • 2021-004807-42 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

IPD Sharing Time Frame

See plan description

IPD Sharing Access Criteria

See plan description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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