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

Last updated: March 25, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Not Recruiting

Phase

2

Condition

Fallopian Tube Cancer

Ovarian Cysts

Treatment

Pegylated Liposomal Doxorubicin (PLD)

Topotecan

MORAb-202

Clinical Study ID

NCT05613088
CA116-001
2021-004807-42
  • Ages > 18
  • Female

Study 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

Inclusion Criteria:

  • Female participants with histologically-confirmed diagnosis of HGS ovarian, primaryperitoneal, 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 4cycles.

  • For participants who had 2 or 3 lines of platinum-based therapy: progression ≤ 6months after the last dose of platinum-based therapy.

  • Participants have received at least 1 but no more than 3 prior lines of systemictherapy and for whom single-agent therapy is appropriate as the next line oftherapy. Participants may have been treated with up to 1 line of therapy subsequentto determination of platinum-resistance.

  • Disease progression per RECIST v1.1 (by investigator assessment) of at least 1measurable lesion on or after the most recent therapy.

  • Either formalin-fixed, paraffin-embedded (FFPE) tissue (up to 5 years old) ornewly-obtained biopsies must be available for FRα assessment prior to randomization.

  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.

Exclusion

Exclusion Criteria:

Medical Conditions

  • Clear cell, mucinous, endometrioid or sarcomatous histology, or mixed tumorscontaining components of any of these histologies, or low grade or borderlineovarian cancer.

  • Primary platinum-refractory ovarian cancer defined as disease progression within 1month 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 atscreening or history of ILD/pneumonitis of any severity including ILD/pneumonitisfrom prior anti-cancer therapy.

  • Significant third-space fluid retention (eg, ascites or pleural effusion) thatrequires repeated drainage.

Physical and Laboratory Test Findings

  • Evidence of organ dysfunction or any clinically-significant deviation from normal inphysical examination, vital signs, ECG, or clinical laboratory determinations beyondwhat is consistent with the target population.

Allergies and Adverse Drug Reactions

  • Has any prior severe hypersensitivity (≥ Grade 3) to monoclonal antibodies oreribulin or contraindication to the receipt of corticosteroids or any of theexcipients (investigators should refer to the prescribing information for theselected corticosteroid).

  • History of allergy or contraindication to IC chemotherapy agent selected ifrandomized to Arm C.

Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Total Participants: 90
Treatment Group(s): 4
Primary Treatment: Pegylated Liposomal Doxorubicin (PLD)
Phase: 2
Study Start date:
February 01, 2023
Estimated Completion Date:
October 11, 2026

Connect with a study center

  • GenesisCare - North Shore

    Sydney, New South Wales 2065
    Australia

    Active - Recruiting

  • Local Institution - 0016

    Sydney, New South Wales 2065
    Australia

    Site Not Available

  • Calvary Mater Newcastle

    Waratah, New South Wales 2298
    Australia

    Active - Recruiting

  • Local Institution - 0017

    Waratah, New South Wales 2298
    Australia

    Site Not Available

  • Icon Cancer Centre - Chermside

    Chermside, Queensland 4032
    Australia

    Site Not Available

  • Local Institution - 0031

    Chermside, Queensland 4032
    Australia

    Site Not Available

  • Local Institution - 0015

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Monash Medical Centre Clayton

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Cabrini Hospital - Malvern

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • Local Institution - 0027

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • Local Institution - 0027

    Melbourne, Victoria 3144
    Australia

    Site Not Available

  • Local Institution - 0058

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Local Institution - 0075

    Perth, Western Australia 6009
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital (SCGH) - WA Cancer Centre

    Perth, Western Australia 6009
    Australia

    Site Not Available

  • Local Institution - 0032

    Leuven, VBR 3000
    Belgium

    Site Not Available

  • Local Institution - 0013

    Namur, WNA 5000
    Belgium

    Site Not Available

  • Local Institution - 0012

    Brussels, 1200
    Belgium

    Site Not Available

  • Local Institution - 0012

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Local Institution - 0033

    Hasselt, 3500
    Belgium

    Site Not Available

  • Local Institution - 0045

    Liège, 4000
    Belgium

    Site Not Available

  • Local Institution - 0059

    Santiago, Metropolitana 8420383
    Chile

    Site Not Available

  • Local Institution - 0030

    Santiago, RM 8420323
    Chile

    Site Not Available

  • Local Institution - 0071

    Vina Del Mar, Valparaiso 2540402
    Chile

    Site Not Available

  • Local Institution - 0060

    Vina del Mar, Valparaiso 2540402
    Chile

    Site Not Available

  • Local Institution - 0036

    Santiago, 7510032
    Chile

    Site Not Available

  • Oncovida - Santiago

    Santiago, 7510032
    Chile

    Site Not Available

  • Local Institution - 0029

    Temuco, 4800827
    Chile

    Site Not Available

  • Local Institution - 0046

    Jerusaelm, JM 9112001
    Israel

    Site Not Available

  • Local Institution - 0047

    Tel-Aviv, Tel Aviv 64239
    Israel

    Site Not Available

  • Local Institution - 0054

    Haifa, 31999
    Israel

    Site Not Available

  • Local Institution - 0046

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Local Institution - 0080

    Jerusalem, 91031
    Israel

    Site Not Available

  • Local Institution - 0055

    Ramat Gan, 5265601
    Israel

    Site Not Available

  • The Chaim Sheba Medical Centre - Division of Oncology

    Ramat Gan, 5265601
    Israel

    Site Not Available

  • Local Institution - 0048

    Tel Aviv-Yafo, 64239
    Israel

    Site Not Available

  • Local Institution - 0068

    Tel Hashomer, 52621
    Israel

    Site Not Available

  • Local Institution - 0048

    Tel-Aviv, 64239
    Israel

    Site Not Available

  • Local Institution - 0003

    Bologna, BO 40138
    Italy

    Site Not Available

  • Local Institution - 0009

    Milano, MI 20141
    Italy

    Site Not Available

  • Local Institution - 0011

    Milano, MI 20132
    Italy

    Site Not Available

  • Local Institution - 0010

    Roma, RM 00168
    Italy

    Site Not Available

  • Local Institution - 0008

    Torino, TO 10126
    Italy

    Site Not Available

  • Local Institution - 0002

    Brescia, 25123
    Italy

    Site Not Available

  • Local Institution - 0004

    Kurume, Fukuoka 8300011
    Japan

    Site Not Available

  • Local Institution - 0037

    Koto-Ku, Tokyo-to 135-8550
    Japan

    Site Not Available

  • Local Institution - 0079

    Akashi, 673-8558
    Japan

    Site Not Available

  • Hyogo Cancer Center

    Akashi, Hyogo, 673-8558
    Japan

    Site Not Available

  • Local Institution - 0018

    Akashi, Hyogo, 673-8558
    Japan

    Site Not Available

  • Local Institution - 0019

    Chuo-Ku, 104-0045
    Japan

    Site Not Available

  • Local Institution - 0014

    Hidaka-shi, 350-1298
    Japan

    Site Not Available

  • Saitama Medical University International Medical Center

    Hidaka-shi, 350-1298
    Japan

    Active - Recruiting

  • Kurume University Hospital

    Kurume-Shi, 830-0011
    Japan

    Active - Recruiting

  • Local Institution - 0004

    Kurume-Shi, 830-0011
    Japan

    Site Not Available

  • Local Institution - 0037

    Tokyo, 135-8550
    Japan

    Site Not Available

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research (JFCR)

    Tokyo, 135-8550
    Japan

    Active - Recruiting

  • Local Institution - 0064

    Goyang-si, 10408
    Korea, Republic of

    Site Not Available

  • Local Institution - 0074

    Goyang-si, 10408
    Korea, Republic of

    Site Not Available

  • Local Institution - 0069

    Jongno -Gu, 110-744
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Jongno -Gu, 110-744
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 5505
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center (AMC)

    Seoul, 5505
    Korea, Republic of

    Active - Recruiting

  • Local Institution - 0049

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Local Institution - 0053

    Seoul, 5505
    Korea, Republic of

    Site Not Available

  • Local Institution - 0056

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Local Institution - 0057

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Local Institution - 0066

    Seoul, 135-710
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Yonsei University Health System, Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Local Institution - 0039

    Barcelona, B 08035
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañón

    Madrid, M 28007
    Spain

    Site Not Available

  • Local Institution - 0001

    Madrid, M 28041
    Spain

    Site Not Available

  • Local Institution - 0005

    Madrid, M 28007
    Spain

    Site Not Available

  • Instituto de Investigacion Sanitaria - Institute of Health Research Hospital Clinic of Valencia

    Valencia, V 46010
    Spain

    Active - Recruiting

  • Local Institution - 0006

    Valencia, V 46010
    Spain

    Site Not Available

  • Local Institution - 0007

    Valencia, V 46009
    Spain

    Site Not Available

  • Local Institution - 0021

    Barcelona, 08036
    Spain

    Site Not Available

  • Local Institution - 0020

    Girona, 17007
    Spain

    Site Not Available

  • Local Institution - 0022

    Madrid, 28046
    Spain

    Site Not Available

  • Local Institution - 0038

    Madrid, 28033
    Spain

    Site Not Available

  • Local Institution - 0040

    Orange, California 92868
    United States

    Site Not Available

  • University of California Irvine

    Orange, California 92868
    United States

    Site Not Available

  • Local Institution - 0065

    Sacramento, California 95817
    United States

    Site Not Available

  • UC Davis Comprehensive Cancer Center

    Sacramento, California 95817-1514
    United States

    Site Not Available

  • California Pacific Medical Center (CPMC) - Research Institute

    San Francisco, California 94109
    United States

    Site Not Available

  • California Pacific Medical Center - Van Ness Campus Medical Office Building

    San Francisco, California 94109-6978
    United States

    Site Not Available

  • Local Institution - 0025

    San Francisco, California 94109
    United States

    Site Not Available

  • Local Institution - 0078

    Whittier, California 90602-3171
    United States

    Site Not Available

  • The Oncology Institute of Hope and Innovation - Whittier

    Whittier, California 90602-3171
    United States

    Active - Recruiting

  • Local Institution - 0051

    Aurora, Colorado 80045-2517
    United States

    Site Not Available

  • University of Colorado Denver - Anschutz Medical Campus

    Aurora, Colorado 80045-2517
    United States

    Site Not Available

  • Local Institution - 0024

    Gainesville, Florida 32611
    United States

    Site Not Available

  • UF Health Endoscopy Center

    Gainesville, Florida 32611
    United States

    Site Not Available

  • Local Institution - 0052

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60208
    United States

    Site Not Available

  • Local Institution - 0081

    South Bend, Indiana 46601-1033
    United States

    Site Not Available

  • Memorial Hospital of South Bend

    South Bend, Indiana 46601
    United States

    Active - Recruiting

  • Local Institution - 0043

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • University Of Kansas Medical Center

    Westwood, Kansas 66205-2003
    United States

    Site Not Available

  • Corewell Health

    Grand Rapids, Michigan 49503-2560
    United States

    Site Not Available

  • Local Institution - 0041

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Spectrum Health Hospitals

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Local Institution - 0034

    Saint Louis, Missouri 63110-1010
    United States

    Site Not Available

  • Local Institution - 0035

    Bronx, New York 10467-2836
    United States

    Site Not Available

  • Local Institution - 0067

    Bronx, New York 10467
    United States

    Site Not Available

  • Columbia University Medical Center - Herbert Irving Pavilion Location

    New York, New York 10032-3729
    United States

    Site Not Available

  • Local Institution - 0026

    New York, New York 10065-6007
    United States

    Site Not Available

  • Local Institution - 0062

    New York, New York 10032
    United States

    Site Not Available

  • Local Institution - 0063

    New York, New York 10016
    United States

    Site Not Available

  • Local Institution - 0073

    New York, New York 10016-6402
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10065-6007
    United States

    Site Not Available

  • Local Institution - 0028

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • University Of North Carolina, Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Aultman Hospital

    Canton, Ohio 44710-1702
    United States

    Completed

  • Local Institution - 0023

    Canton, Ohio 44710-1702
    United States

    Site Not Available

  • Local Institution - 0061

    Columbus, Ohio 43219
    United States

    Site Not Available

  • Local Institution - 0076

    Columbus, Ohio 43219
    United States

    Site Not Available

  • Zangmeister Cancer Center

    Columbus, Ohio 43219
    United States

    Site Not Available

  • Local Institution - 0044

    Nashville, Tennessee 37203-1625
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203-1625
    United States

    Site Not Available

  • Sarah Cannon Research Institute - Tennessee Oncology

    Nashville, Tennessee 37203-1625
    United States

    Active - Recruiting

  • Local Institution - 0050

    Dallas, Texas 75235-7320
    United States

    Site Not Available

  • UT Southwestern-Harold C. Simmons Cancer Center

    Dallas, Texas 75235-7320
    United States

    Site Not Available

  • University Of Texas Southwestern Medical Center

    Dallas, Texas 75235-7320
    United States

    Site Not Available

  • Local Institution - 0082

    Salt Lake City, Utah 84124
    United States

    Site Not Available

  • Utah Cancer Specialists

    Salt Lake City, Utah 84124
    United States

    Site Not Available

  • Providence Sacred Heart Medical Center & Children's Hospital

    Seattle, Washington 98124-5143
    United States

    Site Not Available

  • Local Institution - 0042

    Spokane, Washington 99204
    United States

    Site Not Available

  • Providence Sacred Heart Medical Center & Children's Hospital

    Spokane, Washington 99204
    United States

    Site Not Available

  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington 99204-2307
    United States

    Site Not Available

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