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

May 2, 2024 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

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 Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain the NCT# and Site #.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2065
        • Recruiting
        • Local Institution - 0016
        • Contact:
          • Site 0016
      • Waratah, New South Wales, Australia, 2298
        • Recruiting
        • Calvary Mater Newcastle
        • Contact:
          • Janine Lombard, Site 0017
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • Recruiting
        • Local Institution - 0031
        • Contact:
          • Site 0031
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Local Institution - 0015
        • Contact:
          • Site 0015
      • Melbourne, Victoria, Australia, 3144
        • Not yet recruiting
        • Local Institution - 0027
        • Contact:
          • Site 0027
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Local Institution - 0058
        • Contact:
          • Site 0058
      • Perth, Western Australia, Australia, 6009
        • Recruiting
        • Local Institution - 0075
        • Contact:
          • Site 0075
  • Belgium
      • Brussels, Belgium, 1200
        • Active, not recruiting
        • Local Institution - 0012
      • Liège, Belgium, 4000
        • Completed
        • Local Institution - 0045
    • VBR
      • Leuven, VBR, Belgium, 3000
        • Active, not recruiting
        • Local Institution - 0032
    • VLI
      • Hasselt, VLI, Belgium, 3500
        • Not yet recruiting
        • Local Institution - 0033
        • Contact:
          • Site 0033
    • WNA
      • Namur, WNA, Belgium, 5000
        • Completed
        • Local Institution - 0013
  • Chile
      • Santiago, Chile, 7510032
        • Recruiting
        • Local Institution - 0036
        • Contact:
          • Site 0036
      • Temuco, Chile, 4800827
        • Active, not recruiting
        • Local Institution - 0029
    • RM
      • Santiago, RM, Chile, 8420323
        • Active, not recruiting
        • Local Institution - 0030
    • Valparaiso
      • Vina Del Mar, Valparaiso, Chile, 2540402
        • Withdrawn
        • Local Institution - 0071
  • Israel
      • Haifa, Israel, 31999
        • Completed
        • Local Institution - 0054
      • Jerusalem, Israel, 91031
        • Active, not recruiting
        • Local Institution - 0080
      • Tel Aviv-Yafo, Israel, 64239
        • Completed
        • Local Institution - 0048
      • Tel Hashomer, Israel, 52621
        • Active, not recruiting
        • Local Institution - 0068
    • JM
      • Jerusaelm, JM, Israel, 9112001
        • Completed
        • Local Institution - 0046
    • Tel Aviv
      • Tel-Aviv, Tel Aviv, Israel, 64239
        • Withdrawn
        • Local Institution - 0047
  • Italy
      • Brescia, Italy, 25123
        • Active, not recruiting
        • Local Institution - 0002
    • BO
      • Bologna, BO, Italy, 40138
        • Active, not recruiting
        • Local Institution - 0003
    • MI
      • Milano, MI, Italy, 20132
        • Completed
        • Local Institution - 0011
      • Milano, MI, Italy, 20141
        • Active, not recruiting
        • Local Institution - 0009
    • RM
      • Roma, RM, Italy, 00168
        • Active, not recruiting
        • Local Institution - 0010
  • Japan
      • Akashi, Japan, 673-8558
        • Active, not recruiting
        • Local Institution - 0079
      • Akashi, Hyogo, Japan, 673-8558
        • Recruiting
        • Hyogo Cancer Center
        • Contact:
          • Koji Matsumoto, Site 0018
          • Phone Number: +81789291151
      • Chuo-Ku, Japan, 104-0045
        • Completed
        • Local Institution - 0019
      • Hidaka-shi, Japan, 350-1298
        • Active, not recruiting
        • Local Institution - 0014
      • Kurume-Shi, Japan, 830-0011
        • Active, not recruiting
        • Local Institution - 0004
      • Tokyo, Japan, 135-8550
        • Active, not recruiting
        • Local Institution - 0037
  • Korea, Republic of
      • Goyang-si, Korea, Republic of, 10408
        • Not yet recruiting
        • Local Institution - 0064
        • Contact:
          • Site 0064
      • Jongno -Gu, Korea, Republic of, 110-744
        • Recruiting
        • Local Institution - 0069
        • Contact:
          • Site 0069
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Yonsei University Health System, Severance Hospital
        • Contact:
          • Jung-Yun Lee, Site 0049
          • Phone Number: +82222282246
      • Seoul, Korea, Republic of, 5505
        • Recruiting
        • Asan Medical Center (AMC)
        • Contact:
          • Jeong Yeol Park, Site 0053
  • Spain
      • Barcelona, Spain, 08036
        • Active, not recruiting
        • Local Institution - 0021
      • Girona, Spain, 17007
        • Completed
        • Local Institution - 0020
      • Madrid, Spain, 28033
        • Active, not recruiting
        • Local Institution - 0038
      • Madrid, Spain, 28046
        • Active, not recruiting
        • Local Institution - 0022
    • B
      • Barcelona, B, Spain, 08035
        • Active, not recruiting
        • Local Institution - 0039
    • M
      • Madrid, M, Spain, 28007
        • Recruiting
        • Local Institution - 0005
        • Contact:
          • Site 0005
      • Madrid, M, Spain, 28041
        • Active, not recruiting
        • Local Institution - 0001
    • V
      • Valencia, V, Spain, 46009
        • Active, not recruiting
        • Local Institution - 0007
      • Valencia, V, Spain, 46010
        • Active, not recruiting
        • Local Institution - 0006
  • United States
    • California
      • Orange, California, United States, 92868
        • Not yet recruiting
        • University of California Irvine
        • Contact:
          • Krishnansu Tewari, Site 0040
          • Phone Number: 714-509-2430
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Comprehensive Cancer Center
        • Contact:
          • Hui Chen, Site 0065
      • Sacramento, California, United States, 95817-1514
        • Recruiting
        • UC Davis Comprehensive Cancer Center
        • Contact:
          • Hui Amy Chen, Site 0077
      • San Francisco, California, United States, 94109
        • Recruiting
        • California Pacific Medical Center (CPMC) - Research Institute
        • Contact:
          • John Chan, Site 0025
      • Whittier, California, United States, 90602-3171
        • Completed
        • Local Institution - 0078
    • Colorado
      • Aurora, Colorado, United States, 80045-2517
        • Not yet recruiting
        • University of Colorado Denver - Anschutz Medical Campus
        • Contact:
          • Bradley Corr, Site 0051
          • Phone Number: 303-724-2053
    • Florida
      • Gainesville, Florida, United States, 32611
        • Not yet recruiting
        • UF Health Endoscopy Center
        • Contact:
          • Merry Markham, Site 0024
          • Phone Number: 352-262-1072
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Withdrawn
        • Local Institution - 0052
    • Indiana
      • South Bend, Indiana, United States, 46601-1033
        • Active, not recruiting
        • Local Institution - 0081
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Completed
        • Local Institution - 0043
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Not yet recruiting
        • Spectrum Health Hospitals
        • Contact:
          • Gregory Gressel, Site 0041
          • Phone Number: 616-391-9354
      • Grand Rapids, Michigan, United States, 49503-2560
        • Recruiting
        • Corewell Health
        • Contact:
          • Gregory Gressel, Site 0070
          • Phone Number: 616-391-9354
    • New York
      • Bronx, New York, United States, 10467
        • Withdrawn
        • Local Institution - 0067
      • New York, New York, United States, 10065-6007
        • Not yet recruiting
        • Memorial Sloan-Kettering Cancer Center
        • Contact:
          • Jason Konner, Site 0026
          • Phone Number: 646-227-2198
      • New York, New York, United States, 10032-3729
        • Recruiting
        • Columbia University Medical Center - Herbert Irving Pavilion Location
        • Contact:
          • June Hou, Site 0072
          • Phone Number: 212-305-3410
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Not yet recruiting
        • University Of North Carolina, Chapel Hill
        • Contact:
          • Linda Van Le, Site 0028
          • Phone Number: 919-784-6875
    • Ohio
      • Canton, Ohio, United States, 44710-1702
        • Completed
        • Aultman Hospital
      • Columbus, Ohio, United States, 43219
        • Recruiting
        • Zangmeister Cancer Center
        • Contact:
          • Emily Whitman, Site 0061
      • Columbus, Ohio, United States, 43219
        • Active, not recruiting
        • Local Institution - 0076
    • Tennessee
      • Nashville, Tennessee, United States, 37203-1625
        • Active, not recruiting
        • Local Institution - 0044
    • Texas
      • Dallas, Texas, United States, 75235-7320
        • Active, not recruiting
        • UT Southwestern-Harold C. Simmons Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Completed
        • Local Institution - 0082
    • Washington
      • Seattle, Washington, United States, 98124-5143
        • Recruiting
        • Providence Sacred Heart Medical Center & Children's Hospital
        • Contact:
          • Melanie Bergman, Site 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
Time Frame
Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Time Frame: Up to 2 years
Up to 2 years
Proportion of participants with treatment related adverse events (TRAEs) leading to study discontinuation
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to 2 years
Up to 2 years
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 2 years
Up to 2 years
Number of participants with AEs leading to discontinuation
Time Frame: Up to 2 years
Up to 2 years
Number of participants with TRAEs
Time Frame: Up to 2 years
Up to 2 years
Number of participants with TRSAEs
Time Frame: Up to 2 years
Up to 2 years
Number of participants with AEs of special interest (AESIs)
Time Frame: Up to 2 years
Up to 2 years
Number of deaths
Time Frame: Up to 2 years
Up to 2 years
Number of participants with laboratory abnormalities
Time Frame: Up to 2 years
Up to 2 years
Disease control rate (DCR) by RECIST v1.1 per investigator assessment
Time Frame: Up to 2 years
Up to 2 years
Duration of Response (DoR) by RECIST v1.1 per investigator assessment
Time Frame: Up to 2 years
Up to 2 years
Progression-free survival (PFS) by RECIST v1.1 per investigator assessment
Time Frame: Up to 2 years
Up to 2 years

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 (Estimated)

June 5, 2024

Study Completion (Estimated)

October 11, 2026

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 (Estimated)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

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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