Ovarian Cancer Clinical Trial

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

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.

View Eligibility Criteria

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.

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

90

Study ID:

NCT05613088

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 70 Locations for this study

See Locations Near You

Local Institution - 0040
Orange California, 92868, United States
UC Davis Comprehensive Cancer Center
Sacramento California, 95817, United States More Info
Hui Amy Chen, Site 0077
Contact
UC Davis Comprehensive Cancer Center
Sacramento California, 95817, United States More Info
Hui Chen, Site 0065
Contact
California Pacific Medical Center (CPMC) - Research Institute
San Francisco California, 94109, United States More Info
John Chan, Site 0025
Contact
Local Institution - 0078
Whittier California, 90602, United States
Local Institution - 0051
Aurora Colorado, 80045, United States More Info
Site 0051
Contact
Local Institution - 0024
Gainesville Florida, 32611, United States More Info
Site 0024
Contact
Local Institution - 0052
Chicago Illinois, 60611, United States
Local Institution - 0081
South Bend Indiana, 46601, United States
Local Institution - 0043
Kansas City Kansas, 66160, United States
Corewell Health
Grand Rapids Michigan, 49503, United States More Info
Gregory Gressel, Site 0070
Contact
616-391-9354
Local Institution - 0041
Grand Rapids Michigan, 49503, United States More Info
Site 0041
Contact
Local Institution - 0034
Saint Louis Missouri, 63110, United States
Local Institution - 0035
Bronx New York, 10467, United States More Info
Site 0035
Contact
Local Institution - 0067
Bronx New York, 10467, United States
Local Institution - 0073
New York New York, 10016, United States
Local Institution - 0063
New York New York, 10016, United States More Info
Site 0063
Contact
Columbia University Medical Center - Herbert Irving Pavilion Location
New York New York, 10032, United States More Info
June Hou, Site 0072
Contact
212-305-3410
Local Institution - 0062
New York New York, 10032, United States More Info
Site 0062
Contact
Local Institution - 0026
New York New York, 10065, United States More Info
Site 0026
Contact
Local Institution - 0028
Chapel Hill North Carolina, 27599, United States More Info
Site 0028
Contact
Local Institution - 0023
Canton Ohio, 44710, United States
Local Institution - 0076
Columbus Ohio, 43219, United States
Zangmeister Cancer Center
Columbus Ohio, 43219, United States More Info
Emily Whitman, Site 0061
Contact
Local Institution - 0044
Nashville Tennessee, 37203, United States
Local Institution - 0050
Dallas Texas, 75235, United States
Local Institution - 0082
Salt Lake City Utah, 84124, United States
Providence Sacred Heart Medical Center & Children's Hospital
Spokane Washington, 99204, United States More Info
Melanie Bergman, Site 0042
Contact
GenesisCare - North Shore
Sydney New South Wales, 2065, Australia More Info
Sally Baron Hay, Site 0016
Contact
Calvary Mater Newcastle
Waratah New South Wales, 2298, Australia More Info
Janine Lombard, Site 0017
Contact
Icon Cancer Centre - Chermside
Chermside Queensland, 4032, Australia More Info
Jeffrey Goh, Site 0031
Contact
61402240196
Monash Medical Centre Clayton
Clayton Victoria, 3168, Australia More Info
Sophia Frentzas, Site 0015
Contact
+61 426 2788 74
Cabrini Hospital - Malvern
Malvern Victoria, 3144, Australia More Info
Gary Richardson, Site 0027
Contact
Sir Charles Gairdner Hospital
Nedlands Western Australia, 6009, Australia More Info
Tarek Meniawy, Site 0058
Contact
61893463841
Sir Charles Gairdner Hospital (SCGH) - WA Cancer Centre
Perth Western Australia, 6009, Australia More Info
Tarek Meniawy, Site 0075
Contact
61893463841
Local Institution - 0032
Leuven VBR, 3000, Belgium
Local Institution - 0013
Namur WNA, 5000, Belgium
Local Institution - 0012
Brussels , 1200, Belgium
Local Institution - 0033
Hasselt , 3500, Belgium
Local Institution - 0045
Liège , 4000, Belgium
Local Institution - 0059
Santiago Metropolitana, 84203, Chile
Local Institution - 0030
Santiago RM, 84203, Chile
Local Institution - 0060
Vina del Mar Valparaiso, 25404, Chile More Info
Site 0060
Contact
Local Institution - 0071
Vina Del Mar Valparaiso, 25404, Chile
Oncovida - Santiago
Santiago , 75100, Chile More Info
Pamela Salman Boghikian, Site 0036
Contact
5697215168156
Local Institution - 0029
Temuco , 48008, Chile
Local Institution - 0046
Jerusaelm JM, 91120, Israel
Local Institution - 0047
Tel-Aviv Tel Aviv, 64239, Israel
Local Institution - 0054
Haifa , 31999, Israel
Local Institution - 0080
Jerusalem , 91031, Israel
Local Institution - 0055
Ramat Gan , 52656, Israel More Info
Site 0055
Contact
Local Institution - 0048
Tel Aviv-Yafo , 64239, Israel
Local Institution - 0068
Tel Hashomer , 52621, Israel
Local Institution - 0003
Bologna BO, 40138, Italy
Local Institution - 0011
Milano MI, 20132, Italy
Local Institution - 0009
Milano MI, 20141, Italy
Local Institution - 0010
Roma RM, 00168, Italy
Local Institution - 0008
Torino TO, 10126, Italy More Info
Site 0008
Contact
Local Institution - 0002
Brescia , 25123, Italy
Hyogo Cancer Center
Akashi, Hyogo , 673-8, Japan More Info
Koji Matsumoto, Site 0018
Contact
+81789291151
Local Institution - 0079
Akashi , 673-8, Japan
Local Institution - 0019
Chuo-Ku , 104-0, Japan
Local Institution - 0014
Hidaka-shi , 350-1, Japan
Local Institution - 0004
Kurume-Shi , 830-0, Japan
Local Institution - 0037
Tokyo , 135-8, Japan
Local Institution - 0064
Goyang-si , 10408, Korea, Republic of More Info
Site 0064
Contact
Local Institution - 0074
Goyang-si , 10408, Korea, Republic of More Info
Site 0074
Contact
Seoul National University Hospital
Jongno -Gu , 110-7, Korea, Republic of More Info
Jae-Weon Kim, Site 0069
Contact
Local Institution - 0056
Seoul , 03080, Korea, Republic of More Info
Site 0056
Contact
Yonsei University Health System, Severance Hospital
Seoul , 03722, Korea, Republic of More Info
Jung-Yun Lee, Site 0049
Contact
+82222282246
Local Institution - 0057
Seoul , 06351, Korea, Republic of More Info
Site 0057
Contact
Local Institution - 0066
Seoul , 135-7, Korea, Republic of More Info
Site 0066
Contact
Asan Medical Center (AMC)
Seoul , 5505, Korea, Republic of More Info
Jeong Yeol Park, Site 0053
Contact
Local Institution - 0039
Barcelona B, 08035, Spain
Hospital General Universitario Gregorio Marañón
Madrid M, 28007, Spain More Info
Sara Perez Ramirez, Site 0005
Contact
34914269393
Local Institution - 0001
Madrid M, 28041, Spain
Local Institution - 0007
Valencia V, 46009, Spain
Local Institution - 0006
Valencia V, 46010, Spain
Local Institution - 0021
Barcelona , 08036, Spain
Local Institution - 0020
Girona , 17007, Spain
Local Institution - 0038
Madrid , 28033, Spain
Local Institution - 0022
Madrid , 28046, Spain

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

90

Study ID:

NCT05613088

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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