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 62 Locations for this study

See Locations Near You

University of California Irvine
Orange California, 92868, United States More Info
Krishnansu Tewari, Site 0040
Contact
714-509-2430
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
The Oncology Institute of Hope and Innovation - Whittier
Whittier California, 90602, United States More Info
Paul La Porte, Site 0078
Contact
562-693-4777
University of Colorado Denver - Anschutz Medical Campus
Aurora Colorado, 80045, United States More Info
Bradley Corr, Site 0051
Contact
303-724-2053
UF Health Endoscopy Center
Gainesville Florida, 32611, United States More Info
Merry Markham, Site 0024
Contact
352-262-1072
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
Spectrum Health Hospitals
Grand Rapids Michigan, 49503, United States More Info
Gregory Gressel, Site 0041
Contact
616-391-9354
Local Institution - 0067
Bronx New York, 10467, United States
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
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States More Info
Jason Konner, Site 0026
Contact
646-227-2198
University Of North Carolina, Chapel Hill
Chapel Hill North Carolina, 27599, United States More Info
Linda Van Le, Site 0028
Contact
919-784-6875
Aultman Hospital
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
UT Southwestern-Harold C. Simmons Cancer Center
Dallas Texas, 75235, United States
Local Institution - 0082
Salt Lake City Utah, 84124, United States
Providence Sacred Heart Medical Center & Children's Hospital
Seattle Washington, 98124, United States More Info
Melanie Bergman, Site 0042
Contact
Local Institution - 0016
Sydney New South Wales, 2065, Australia More Info
Site 0016
Contact
Local Institution - 0031
Chermside Queensland, 4032, Australia More Info
Site 0031
Contact
Local Institution - 0015
Clayton Victoria, 3168, Australia More Info
Site 0015
Contact
Local Institution - 0027
Melbourne Victoria, 3144, Australia More Info
Site 0027
Contact
Local Institution - 0058
Nedlands Western Australia, 6009, Australia More Info
Site 0058
Contact
Local Institution - 0075
Perth Western Australia, 6009, Australia More Info
Site 0075
Contact
Local Institution - 0032
Leuven VBR, 3000, Belgium
Local Institution - 0033
Hasselt VLI, 3500, Belgium More Info
Site 0033
Contact
Local Institution - 0013
Namur WNA, 5000, Belgium
Local Institution - 0012
Brussels , 1200, Belgium
Local Institution - 0045
Liège , 4000, Belgium
Local Institution - 0030
Santiago RM, 84203, Chile
Local Institution - 0071
Vina Del Mar Valparaiso, 25404, Chile
Local Institution - 0036
Santiago , 75100, Chile More Info
Site 0036
Contact
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 - 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 - 0002
Brescia , 25123, Italy
Local Institution - 0018
Akashi, Hyogo , 673-8, Japan More Info
Site 0018
Contact
Local Institution - 0079
Akashi , 673-8, Japan More Info
Site 0079
Contact
Local Institution - 0019
Chuo-Ku , 104-0, Japan More Info
Site 0019
Contact
Saitama Medical University International Medical Center
Hidaka-shi , 350-1, Japan More Info
Kosei Hasegawa, Site 0014
Contact
Kurume University Hospital
Kurume-Shi , 830-0, Japan More Info
Shin Nishio, Site 0004
Contact
+81942317200
The Cancer Institute Hospital of Japanese Foundation for Cancer Research (JFCR)
Tokyo , 135-8, Japan More Info
Mayu Yunokawa, Site 0037
Contact
+81335700111
Local Institution - 0064
Goyang-si , 10408, Korea, Republic of More Info
Site 0064
Contact
Local Institution - 0069
Jongno -Gu , 110-7, Korea, Republic of More Info
Site 0069
Contact
Yonsei University Health System, Severance Hospital
Seoul , 03722, Korea, Republic of More Info
Jung-Yun Lee, Site 0049
Contact
+82222282246
Asan Medical Center
Seoul , 5505, Korea, Republic of More Info
Jeong Yeol Park, Site 0053
Contact
Local Institution - 0039
Barcelona B, 08035, Spain
Local Institution - 0005
Madrid M, 28007, Spain More Info
Site 0005
Contact
Local Institution - 0001
Madrid M, 28041, Spain
Local Institution - 0007
Valencia V, 46009, Spain
Instituto de Investigacion Sanitaria - Institute of Health Research Hospital Clinic of Valencia
Valencia V, 46010, Spain More Info
Jose Perez-Fidalgo, Site 0006
Contact
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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