A Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Participants With Low CA125 Platinum-sensitive Ovarian Cancer

NCT02289950 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: MORAb-003-011
• Study Type: interventional
• Target: 332
• Locations: 7 countries
• Sites: 68

Brief Summary

MORAb-003-011 is a global, multicenter, double-blind, randomized placebo-controlled study to assess the safety and efficacy of farletuzumab in combination with standard chemotherapy in subjects with low cancer antigen 125 (CA125) platinum-sensitive ovarian cancer in first relapse.

Conditions

Platinum-Sensitive Ovarian Cancer in First Relapse

Keywords

Ovarian Cancer in in first relapse; Platinum-Sensitive

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS was defined as the time (in months) from the date of randomization of a participant to the date of first observation of progression or date of death, whatever the cause. PFS was assessed based on the investigators' assessments utilizing Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Disease progression (PD) was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.

  From the date of randomization to the date of first documentation of PD, or date of death, whichever occurs first up to approximately 5 years 5 months

Secondary Outcomes (5)

• Overall Survival (OS)

  From the date of randomization until the date of death (up to approximately 5 years 5 months)

• Number of Participants With Best Overall Response (BOR)

  From first dose of study drug (Baseline) up to approximately 5 years 5 months

• Time to Tumor Response (TTR)

  From the date of randomization until date of first observation of response (CR or PR) up to approximately 5 years 5 months

• Duration of Response (DOR)

  From date of the first observation of CR or PR until the date of first observation of progression or date of death up to approximately 5 years 5 months

• Percentage of Participants Achieving Each Second Platinum-Free Interval Stratified by First Platinum-Free Interval

  From the date of randomization to the date of first relapse (or first observation of progression/death) up to approximately 5 year 5 months

Study Arms (2)

Farletuzumab

EXPERIMENTAL

All participants will receive a loading dose for the first 2 weeks of 10 milligram per kilogram (mg/kg) farletuzumab, followed by 5 mg/kg weekly farletuzumab administered intravenously (IV).

Drug: Farletuzumab

Placebo

PLACEBO COMPARATOR

All subjects will receive placebo weekly, administered intravenously (IV).

Drug: Placebo

Interventions

Farletuzumab DRUG

Farletuzumab will be administered intravenously (IV) weekly

Farletuzumab

Placebo DRUG

Placebo will be administered intravenously (IV) weekly

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subjects who are at least 18 years of age at the time of informed consent
• CA125 less than or equal to 3 x upper limit of normal (ULN) \[105 units per millilitre (U/mL)\] confirmed within 2 weeks of randomization using a centralized laboratory assay
• A histologically confirmed diagnosis of high-grade serous epithelial ovarian cancer including primary peritoneal and fallopian tube malignancies; all other histologies, including mixed histology, are excluded
• Have been treated with debulking surgery and a first-line platinum-based chemotherapy regimen
• Maintenance therapy during the first platinum-free interval is allowed; however, the last dose must have been at least 21 days prior to Randomization.
• Must be in a first relapse and have evaluable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan, according to RECIST 1.1 (subjects with measurable disease per RECIST 1.1 or radiographically visible and evaluable disease). Subjects with only ascites or pleural effusion are excluded.
• Must have relapsed radiographically between 6 months and 36 months of completion of first-line platinum chemotherapy
• Must be a candidate for treatment with either carboplatin plus paclitaxel or carboplatin plus PLD with no medical contraindications present as outlined in the product labels for the selected regimen to be used in this study
• Have a life expectancy of at least 6 months, as estimated by the investigator
• Other significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to Randomization
• Have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• Subjects being enrolled to receive paclitaxel plus carboplatin treatment must have neuropathic function (sensory and motor less than or equal to Grade 2 according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v4.03 (2010)
• Laboratory results within the 2 weeks prior to Randomization must be as follows:
• Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10\^9/L
• Platelet count greater than or equal to 100 x 10\^9/L

You may not qualify if:

• Known central nervous system (CNS) tumor involvement
• Evidence of other active invasive malignancy requiring treatment other than surgery in the past 3 years
• Clinically significant heart disease (eg, congestive heart failure of New York Heart Association Class 3 or 4 angina, not well controlled by medication, or myocardial infarction within 6 months)
• Electrocardiogram (ECG) demonstrating clinically significant arrhythmias that are not adequately medically managed (Note: subjects with chronic atrial arrhythmia, ie, atrial fibrillation or paroxysmal supraventricular tachycardia \[SVT\], are eligible)
• Active serious systemic disease, including active bacterial or fungal infection
• Other concurrent immunotherapy (eg, immunosuppressants or chronic use of systemic corticosteroids, with the exception that low-dose corticosteroids \[50 mg/day prednisone or equivalent corticosteroid\] are allowed; these should be discussed with the Medical Monitor)
• Known allergic reaction to a prior monoclonal antibody therapy or have any documented Anti-Drug Antibody (ADA) response; additionally known allergic reaction to the concomitant chemotherapies selected by the investigator for planned treatment in this study unless desensitization is planned
• Previous treatment with farletuzumab or other folate receptor targeting agents
• Previous treatment with cancer vaccine therapy
• For subjects being enrolled to receive PLD plus carboplatin, prior treatment with anthracyclines or anthracenodiones
• Breast-feeding, pregnant, or likely to become pregnant during the study
• Any medical or other condition that, in the opinion of the investigator, would preclude the subject's participation in a clinical study including medical contraindications as outlined in the product labels for the chemotherapies selected by the investigator for planned treatment in this study
• Patients who have had secondary debulking surgery or any second line therapy
• Currently enrolled in another clinical study or used any investigational drug or device within 30 days (or 5 x half-life for investigational drugs where the half-life is known) preceding informed consent

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (68)

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Phoenix, Arizona, United States

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Los Angeles, California, United States

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Orange, California, United States

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Roseville, California, United States

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Sacramento, California, United States

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Aurora, Colorado, United States

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Miami, Florida, United States

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Miramar, Florida, United States

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Orlando, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Savannah, Georgia, United States

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Chicago, Illinois, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Minneapolis, Minnesota, United States

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Grand Island, Nebraska, United States

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New York, New York, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Centerville, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Chattanooga, Tennessee, United States

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Knoxville, Tennessee, United States

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Austin, Texas, United States

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Annandale, Virginia, United States

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Charlottesville, Virginia, United States

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Edegem, Antwerpen, Belgium

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Brussels, Brussels Capital, Belgium

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Hasselt, Limburg, Belgium

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Ghent, Oost-Vlaanderen, Belgium

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Leuven, Belgium

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Liège, Belgium

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Ulm, Baden-Wurttemberg, Germany

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Chemnitz, Saxony, Germany

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Berlin, Germany

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Dresden, Germany

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Essen, Germany

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Bari, Apulia, Italy

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Napoli, Campania, Italy

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Rome, Lazio, Italy

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Avellino, Italy

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Bologna, Italy

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Milan, Italy

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Napoli, Italy

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Perugia, Italy

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Chūōku, Japan

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Hidaka, Japan

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Kashiwa, Japan

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Kōtoku, Japan

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Kurume, Japan

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Matsuyama, Japan

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Minatoku, Japan

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SuntoGun, Japan

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Palma de Mallorca, Balearic Islands, Spain

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Córdoba, Córdoba, Spain

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Madrid, Spain

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Sabadell, Spain

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Plymouth, Devon, United Kingdom

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London, United Kingdom

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Related Publications (1)

• Herzog TJ, Pignata S, Ghamande SA, Rubio MJ, Fujiwara K, Vulsteke C, Armstrong DK, Sehouli J, Coleman RL, Gabra H, Scambia G, Monk BJ, Arranz JA, Ushijima K, Hanna R, Zamagni C, Wenham RM, Gonzalez-Martin A, Slomovitz B, Jia Y, Ramsay L, Tewari KS, Weil SC, Vergote IB. Randomized phase II trial of farletuzumab plus chemotherapy versus placebo plus chemotherapy in low CA-125 platinum-sensitive ovarian cancer. Gynecol Oncol. 2023 Mar;170:300-308. doi: 10.1016/j.ygyno.2023.01.003. Epub 2023 Feb 7.

  PMID: 36758420 DERIVED

MeSH Terms

Interventions

farletuzumab

Results Point of Contact

• Title: Eisai Medical Information
• Organization: Eisai Inc.

esi_oncmedinfo@eisai.com

888-274-2378

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: November 13, 2014
• Study Start: March 19, 2015
• Primary Completion: May 31, 2019
• Study Completion: August 13, 2020
• Last Updated: September 2, 2021
• Results First Posted: September 2, 2021

Record last verified: 2021-08

Locations

BE (6); ES (4); GB (2); DE (5); IT (8); US (35); JP (8)