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:

150

Study ID:

NCT05613088

Recruitment Status:

Not yet recruiting

Sponsor:

Bristol-Myers Squibb

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There are 38 Locations for this study

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University of California Irvine
Orange California, 92868, United States More Info
Krishnansu Tewari, Site 0040
Contact
714-509-2430
California Pacific Medical Center - Van Ness Campus Medical Office Building
San Francisco California, 94109, United States More Info
John Chan, Site 0025
Contact
415-600-0930
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
Northwestern University
Chicago Illinois, 60208, United States More Info
Dario Roque, Site 0052
Contact
312-695-0990
University Of Kansas Medical Center
Westwood Kansas, 66205, United States More Info
Andrea Jewell, Site 0043
Contact
000-000-0000
Spectrum Health Hospitals
Grand Rapids Michigan, 49503, United States More Info
Gregory Gressel, Site 0041
Contact
616-391-9354
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
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
Erika Hamilton, Site 0044
Contact
615-329-7274
University Of Texas Southwestern Medical Center
Dallas Texas, 75235, United States More Info
David Miller, Site 0050
Contact
214-645-4673
Providence Sacred Heart Medical Center and Children's Hospital
Spokane Washington, 99204, United States More Info
Melanie Bergman, Site 0042
Contact
509-474-2200
Local Institution - 0031
Chermside Queensland, 4032, Australia More Info
Site 0031
Contact
Local Institution - 0027
Melbourne Victoria, 3144, Australia More Info
Site 0027
Contact
Local Institution - 0032
Leuven VBR, 3000, Belgium More Info
Site 0032
Contact
Local Institution - 0033
Hasselt VLI, 3500, Belgium More Info
Site 0033
Contact
Local Institution - 0012
Bruxelles , 1200, Belgium More Info
Site 0012
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Local Institution - 0045
Liège , 4000, Belgium More Info
Site 0045
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Local Institution - 0013
Namur , 5000, Belgium More Info
Site 0013
Contact
Local Institution - 0029
Temuco Araucania, 47811, Chile More Info
Site 0029
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Local Institution - 0036
Santiago Providencia, 75100, Chile More Info
Site 0036
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Local Institution - 0030
Santiago RM, 84203, Chile More Info
Site 0030
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Local Institution - 0054
Haifa , 31999, Israel More Info
Site 0054
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Local Institution - 0046
Jerusalem , 91120, Israel More Info
Site 0046
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Local Institution - 0047
Tel-Aviv , 64239, Israel
Local Institution - 0048
Tel-Aviv , 64239, Israel More Info
Site 0048
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Local Institution - 0003
Bologna , 40138, Italy More Info
Site 0003
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Local Institution - 0002
Brescia , 25123, Italy More Info
Site 0002
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Local Institution - 0004
Kurume Fukuoka, 83000, Japan More Info
Site 0004
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Local Institution - 0014
Hidaka-shi Saitama, 350-1, Japan More Info
Site 0014
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Local Institution - 0019
Chuo-Ku Tokyo-To, 104-0, Japan More Info
Site 0019
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Local Institution - 0037
Koto-Ku Tokyo-to, 135-8, Japan More Info
Site 0037
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Local Institution - 0018
Akashi, Hyogo , 673-8, Japan More Info
Site 0018
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Local Institution - 0049
Seoul , 03722, Korea, Republic of More Info
Site 0049
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Local Institution - 0053
Seoul , 05505, Korea, Republic of More Info
Site 0053
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Local Institution - 0021
Barcelona , 08036, Spain More Info
Site 0021
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Local Institution - 0020
Girona , 17007, Spain More Info
Site 0020
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Local Institution - 0038
Madrid , 28033, Spain More Info
Site 0038
Contact
Local Institution - 0022
Madrid , 28046, Spain More Info
Site 0022
Contact

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

150

Study ID:

NCT05613088

Recruitment Status:

Not yet recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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