Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse
TerminatedPhase 3Results postedLast updated 30 December 2022
What this trial tests
Phase 3 trial testing Farletuzumab in Ovarian Cancer in 1,100 participants. Terminated before completion.
18 and older, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival (PFS)Primary· From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)
PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression based on the independent radiologic assessment (modified response evaluation criteria in solid tumors \[RECIST\]), or date of death, whatever the cause. As per RECIST, disease progression was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. If progression or death was not observed for a participant, the PFS time was censored at the date of the last tumor assessment
Group
Value
95% CI
1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin
9.5
8.6 – 10.2
2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin
9.7
8.8 – 10.4
Placebo Plus Taxane and Carboplatin
9.0
8.4 – 9.8
Overall Survival (OS)Secondary· From the date of randomization until date of death from any cause, or study termination by sponsor, whichever came first (up to 48 months)
OS was defined as the time (in months) from the date of randomization to the date of death, due to any cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.
Group
Value
95% CI
1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin
28.7
26.6 – 33.5
2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin
32.1
26.7 – 35.0
Placebo Plus Taxane and Carboplatin
29.1
25.6 – 30.7
Cancer Antigen-125 (CA-125) Progression-Free SurvivalSecondary· From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)
CA-125 PFS was defined as the time (in months) from the date of randomization until the date of the first observation of progression based on the Rustin criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, the CA-125 PFS time was censored at the date of the last CA-125 assessment without evidence of progression before the date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Based on Rustin criteria, progressive disease (PD) was a rise in CA125 since beginning of consolidation or p
Group
Value
95% CI
1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin
13.2
11.8 – 14.4
2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin
18.1
12.7 – NA
Placebo Plus Taxane and Carboplatin
12.0
11.1 – 14.6
Progression-Free Survival Based on Gynecologic Cancer InterGroup (GCIG) CriteriaSecondary· From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)
PFS using GCIG criteria was defined as time (in months) from date of randomization until date of first observation of progression based on GCIG criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, GCIG PFS time was censored at later date of last tumor assessment or CA-125 assessment without evidence of progression before date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Disease progression per GCIG: Participants with elevated CA-125 pretreatment and normalisation of CA-125 must
Group
Value
95% CI
1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin
8.8
8.4 – 9.7
2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin
8.6
8.3 – 9.5
Placebo Plus Taxane and Carboplatin
8.4
8.2 – 9.0
Percentage of Participants With Length of Second Remission Greater Than First RemissionSecondary· From the date of last dose of platinum-based chemotherapy to date of relapse and date of last dose of platinum-based chemotherapy to first observation of progression (up to 48 months)
Length of first remission was defined as a.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy until date of first relapse (that is, first observation of progression). It was assumed that the date of first relapse was the earlier of progression by CA-125 or progression by radiologic assessment, as judged by the investigator using GCIG criteria. b.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy (used prior to study entry) until date of randomization. The length of the second remission was defin
Group
Value
95% CI
1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin
4.0
1.8 – 7.8
2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin
6.5
3.5 – 10.9
Placebo Plus Taxane and Carboplatin
4.5
2.1 – 8.3
Percentage of Participants With Objective ResponseSecondary· From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 48 months)
Objective response was defined as either a confirmed complete response (CR) or confirmed partial response (PR) as assessed by investigator based on response evaluation criteria in solid tumors version 1.1 (RECIST version 1.1). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.
Group
Value
95% CI
1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin
57.6
52.4 – 62.7
2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin
58.2
53.0 – 63.3
Placebo Plus Taxane and Carboplatin
55.8
50.5 – 60.9
Duration of Tumor ResponseSecondary· From the first date of confirmed objective response (CR or PR) to first date of progression or death due to any cause (up to 48 months)
Duration of response was defined as the time (in months) from first documentation of objective response (confirmed CR or PR) to the first documentation of objective tumor progression or death due to any cause. Duration of response was derived only for those participants with objective evidence of confirmed CR or PR.
Group
Value
95% CI
1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin
8.0
7.6 – 9.2
2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin
8.9
7.7 – 9.7
Placebo Plus Taxane and Carboplatin
7.6
7.1 – 8.7
Time to Tumor Response (TTR)Secondary· From the date of randomization to first documentation of objective response (up to 48 months)
Time to tumor response was defined as the time (in months) from the date of randomization to first documentation of objective tumor response. Time to tumor response was derived for those participants with objective evidence of CR or PR.
Group
Value
95% CI
1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin
1.5
1.4 – 1.7
2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin
1.5
1.4 – 1.7
Placebo Plus Taxane and Carboplatin
1.5
1.4 – 1.9
Percentage of Participants With Serologic Response (SR)Secondary· Up to 48 months
SR was defined as either normalization, 75% response, or 50% response using the Rustin criteria. Percentage of participants with 50% SR, 75% SR and SR leading to normalization were reported. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of four CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level). A 75% response was established if there had a serial decrease in serum CA-125 levels of 75% over three samples. In both the 50% and
50% SR (Responder)
Group
Value
95% CI
1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin
91.9
88.1 – 94.9
2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin
97.4
94.8 – 99.0
Placebo Plus Taxane and Carboplatin
92.3
88.4 – 95.2
75% SR (Responder)
Group
Value
95% CI
1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin
86.1
81.4 – 90.0
2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin
85.7
81.0 – 89.6
Placebo Plus Taxane and Carboplatin
82.0
76.9 – 86.4
SR leading to normalization (Responder)
Group
Value
95% CI
1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin
65.2
59.2 – 70.8
2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin
64.8
58.9 – 70.5
Placebo Plus Taxane and Carboplatin
59.9
53.8 – 65.8
Duration of 50% Serologic ResponseSecondary· From the first date of documentation of response to first documentation of serologic progression or death due to any cause (up to 48 months)
Duration of SR was defined as the time (in months) from first documentation of response to the first documentation of 50% serologic progression or death due to any cause. For responding participants who did not have serologic progression or did not die and who 1) were either still on study at the time of an analysis, 2) were given antitumor treatment other than study treatment, or 3) were withdrawn from study follow-up before documentation of serologic progression, the duration of SR was censored at the last date the participant was known to be without serologic progression. A 50% response acc
Group
Value
95% CI
1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin
10.7
9.7 – 12.0
2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin
12.0
10.4 – 16.7
Placebo Plus Taxane and Carboplatin
9.9
9.0 – 11.5
Time to 50% Serologic Response (TSR)Secondary· From the date of randomization to first documentation of 50% SR (up to 48 months)
TSR was defined as the time (in months) from the date of randomization to first documentation of 50% SR. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level).
Group
Value
95% CI
1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin
1.0
0.9 – 1.0
2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin
0.9
0.9 – 1.0
Placebo Plus Taxane and Carboplatin
1.2
1.0 – 1.4
Percentage of Participants With Clinical BenefitSecondary· Up to 48 months
Clinical benefit was defined as a confirmed CR or a confirmed PR, or stable disease (SD) using RECIST 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference small
Group
Value
95% CI
1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin
68.9
2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin
66.4
Placebo Plus Taxane and Carboplatin
64.6
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 48 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin
Serious: 140/376 (37%)
Deaths: 143/376
2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin
This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02289950 — A Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or
· Phase 2
· completed
NCT01218516 — A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung
· Phase 2
· completed
Other recruiting trials for Ovarian Cancer
Currently open trials in the same condition.
NCT06412120 — Study Evaluating Safety, Tolerability, and Metabolism of Niraparib
· Phase 4
· recruiting
NCT06930755 — Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer
· Phase 1
· recruiting
NCT07318558 — A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)
· Phase 3
· recruiting
NCT07491081 — EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection
· NA
· recruiting
NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors
· Phase 1, PHASE2
· recruiting
Other Morphotek trials
Trials by the same sponsor.
NCT02357147 — Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectabl
· Phase 2
· terminated
NCT01761240 — Dose Escalation Study MORAb-066 Targeting Tissue Factor (TF)-Expressing Malignancies Including Breast, Pancreatic, Color
· Phase 1
· completed
NCT01574716 — Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation
· Phase 2
· completed
NCT01507545 — Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO)
· Phase 2
· terminated
NCT01218516 — A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Morphotek
Last refreshed: 30 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00849667.