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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03564340
Registration number
NCT03564340
Ethics application status
Date submitted
17/05/2018
Date registered
20/06/2018
Date last updated
3/06/2024
Titles & IDs
Public title
Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers
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Scientific title
A Phase 1/2 Study of REGN4018 (A MUC16xCD3 Bispecific Antibody) Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers
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Secondary ID [1]
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2019-003298-24
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Secondary ID [2]
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R4018-ONC-1721
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Recurrent Ovarian Cancer
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Recurrent Fallopian Tube Cancer
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Recurrent Primary Peritoneal Cancer
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Recurrent Endometrial Cancer
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Condition category
Condition code
Cancer
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0
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Ovarian and primary peritoneal
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Cancer
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0
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0
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Womb (Uterine or endometrial cancer)
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Other
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0
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - REGN4018
Treatment: Drugs - cemiplimab
Treatment: Drugs - Sarilumab
Experimental: Monotherapy - REGN4018 administration
Experimental: Combination Therapy - REGN4018 and cemiplimab administration
Treatment: Drugs: REGN4018
REGN4018 will be administered in a series of dose escalation and dose expansion cohorts by intravenous (IV) infusion and/or subcutaneous (SC) as described in the protocol.
Treatment: Drugs: cemiplimab
Cemiplimab will be administered by IV infusion after REGN4018 monotherapy lead-in phase.
Treatment: Drugs: Sarilumab
Sarilumab will be administered by IV, one-time-only, prior to IV/SC REGN4018.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with Dose-limiting toxicity (DLTs) for REGN4018 monotherapy
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Assessment method [1]
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Dose Escalation Phase
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Timepoint [1]
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From Cycle 1, Day 1 up to 35 days
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Primary outcome [2]
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0
Number of participants with DLTs for REGN4018 with cemiplimab
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Assessment method [2]
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0
Dose Escalation Phase
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Timepoint [2]
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From Cycle 2, Day 1 up to 21 days
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Primary outcome [3]
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Number of participants with Treatment-emergent adverse event (TEAE)s (including immune-related adverse events (imAEs)) for REGN4018 monotherapy
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Assessment method [3]
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0
Dose Escalation Phase
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Timepoint [3]
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Up to 62 weeks
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Primary outcome [4]
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0
Number of participants with TEAEs (including imAEs) for REGN4018 with cemiplimab
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Assessment method [4]
0
0
Dose Escalation Phase
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Timepoint [4]
0
0
Up to 62 weeks
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Primary outcome [5]
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0
Number of participants with serious adverse events (SAEs) for REGN4018 monotherapy
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Assessment method [5]
0
0
Dose Escalation Phase
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Timepoint [5]
0
0
Up to 62 weeks
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Primary outcome [6]
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0
Number of participants with SAEs for REGN4018 with cemiplimab
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Assessment method [6]
0
0
Dose Escalation Phase
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Timepoint [6]
0
0
Up to 62 weeks
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Primary outcome [7]
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0
Number of deaths for REGN4018 monotherapy
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Assessment method [7]
0
0
Dose Escalation Phase
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Timepoint [7]
0
0
Up to 62 weeks
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Primary outcome [8]
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Number of deaths for REGN4018 with cemiplimab
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Assessment method [8]
0
0
Dose Escalation Phase
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Timepoint [8]
0
0
Up to 62 weeks
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Primary outcome [9]
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0
Number of participants with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) for REGN4018 monotherapy
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Assessment method [9]
0
0
Dose Escalation Phase
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Timepoint [9]
0
0
Up to 62 weeks
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Primary outcome [10]
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0
Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for REGN4018 with cemiplimab
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Assessment method [10]
0
0
Dose Escalation Phase
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Timepoint [10]
0
0
Up to 62 weeks
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Primary outcome [11]
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Concentration of REGN4018 in serum over time for REGN4018 monotherapy
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Assessment method [11]
0
0
Dose Escalation Phase
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Timepoint [11]
0
0
Up to 62 weeks
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Primary outcome [12]
0
0
Concentration of REGN4018 in serum over time for REGN4018 with cemiplimab
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Assessment method [12]
0
0
Dose Escalation Phase
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Timepoint [12]
0
0
Up to 62 weeks
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Primary outcome [13]
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0
Objective response rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for REGN4018 monotherapy
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Assessment method [13]
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0
Dose Expansion Phase
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Timepoint [13]
0
0
Up to 62 weeks
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Primary outcome [14]
0
0
ORR defined by RECIST 1.1 for REGN4018 with cemiplimab
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Assessment method [14]
0
0
Dose Expansion Phase
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Timepoint [14]
0
0
Up to 62 weeks
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Secondary outcome [1]
0
0
ORR based on RECIST 1.1 for REGN4018 monotherapy
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Assessment method [1]
0
0
Dose Escalation Phase
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Timepoint [1]
0
0
Up to 62 weeks
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Secondary outcome [2]
0
0
ORR based on RECIST 1.1 for REGN4018 with cemiplimab
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Assessment method [2]
0
0
Dose Escalation Phase
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Timepoint [2]
0
0
Up to 62 weeks
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Secondary outcome [3]
0
0
Number of participants with TEAEs (including imAEs) for REGN4018 monotherapy
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Assessment method [3]
0
0
Dose Expansion Phase
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Timepoint [3]
0
0
Up to 62 weeks
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Secondary outcome [4]
0
0
Number of participants with TEAEs (including imAEs) for REGN4018 with cemiplimab
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Assessment method [4]
0
0
Dose Expansion Phase
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Timepoint [4]
0
0
Up to 62 weeks
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Secondary outcome [5]
0
0
Number of participants with SAEs for REGN4018 monotherapy
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Assessment method [5]
0
0
Dose Expansion Phase
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Timepoint [5]
0
0
Up to 62 weeks
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Secondary outcome [6]
0
0
Number of participants with SAEs for REGN4018 with cemiplimab
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Assessment method [6]
0
0
Dose Expansion Phase
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Timepoint [6]
0
0
Up to 62 weeks
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Secondary outcome [7]
0
0
Number of deaths for REGN4018 monotherapy
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Assessment method [7]
0
0
Dose Expansion Phase
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Timepoint [7]
0
0
Up to 62 weeks
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Secondary outcome [8]
0
0
Number of deaths for REGN4018 with cemiplimab
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Assessment method [8]
0
0
Dose Expansion Phase
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Timepoint [8]
0
0
Up to 62 weeks
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Secondary outcome [9]
0
0
Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for REGN4018 monotherapy
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Assessment method [9]
0
0
Dose Expansion Phase
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Timepoint [9]
0
0
Up to 62 weeks
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Secondary outcome [10]
0
0
Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for REGN4018 with cemiplimab
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Assessment method [10]
0
0
Dose Expansion Phase
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Timepoint [10]
0
0
Up to 62 weeks
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Secondary outcome [11]
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0
Concentration of REGN4018 in serum over time for REGN4018 monotherapy
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Assessment method [11]
0
0
Dose Expansion Phase
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Timepoint [11]
0
0
Up to 62 weeks
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Secondary outcome [12]
0
0
Concentration of REGN4018 in serum over time for REGN4018 with cemiplimab
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Assessment method [12]
0
0
Dose Expansion Phase
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Timepoint [12]
0
0
Up to 62 weeks
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Secondary outcome [13]
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Change from baseline in quality of life (QoL) as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 GHS/QoL score for REGN4018 monotherapy
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Assessment method [13]
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Dose Expansion Phase
The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social) , symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
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Timepoint [13]
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Baseline up to 62 weeks
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Secondary outcome [14]
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Change from baseline in quality of life (QoL) as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 GHS/QoL score for REGN4018 with cemiplimab
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Assessment method [14]
0
0
Dose Expansion Phase
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Timepoint [14]
0
0
Baseline up to 62 weeks
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Secondary outcome [15]
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Change from baseline in physical functioning as measured by the EORTC QLQ-C30 physical functioning score for REGN4018 monotherapy
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Assessment method [15]
0
0
Dose Expansion Phase
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Timepoint [15]
0
0
Baseline up to 62 weeks
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Secondary outcome [16]
0
0
Change from baseline in physical functioning as measured by the EORTC QLQ-C30 physical functioning score for REGN4018 with cemiplimab
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Assessment method [16]
0
0
Dose Expansion Phase
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Timepoint [16]
0
0
Baseline up to 62 weeks
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Secondary outcome [17]
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0
Change from baseline in abdominal symptoms as measured by the Measure of Ovarian Symptoms and Treatment (MOST)-Abdominal index score for REGN4018 monotherapy
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Assessment method [17]
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0
Dose Expansion Phase excluding the Endometrial Cancer Cohort
The MOST-24 is a 24-item questionnaire used to measure the impact of chemotherapy on symptoms (21 items) and well-being (3 items). The expected questionnaire completion time is less than 5 minutes.
The prevalence of each MOST item at assessment time points can be summarized by providing the mean, standard deviation and proportions based on the MOST response format, a numeric rating scale with integers from zero to 10, with five verbal anchors: 'No trouble at all' (0), 'Mild' (1-3), 'Moderate' (4-6), 'Severe' (7-10), and 'Worst I can imagine' (10).
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Timepoint [17]
0
0
Baseline up to 62 weeks
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Secondary outcome [18]
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0
Change from baseline in abdominal symptoms as measured by the MOST-Abdominal index score for REGN4018 with cemiplimab
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Assessment method [18]
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Dose Expansion Phase Not applicable to Endometrial Cancer Cohort
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Timepoint [18]
0
0
Baseline up to 62 weeks
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Secondary outcome [19]
0
0
Time to deterioration in GHS/QoL for REGN4018 monotherapy
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Assessment method [19]
0
0
Dose Expansion Phase
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Timepoint [19]
0
0
Up to 62 weeks
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Secondary outcome [20]
0
0
Time to deterioration in GHS/QoL for REGN4018 with cemiplimab
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Assessment method [20]
0
0
Dose Expansion Phase
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Timepoint [20]
0
0
Up to 62 weeks
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Secondary outcome [21]
0
0
Time to deterioration in physical functioning for REGN4018 monotherapy
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Assessment method [21]
0
0
Dose Expansion Phase
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Timepoint [21]
0
0
Up to 62 weeks
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Secondary outcome [22]
0
0
Time to deterioration in physical functioning for REGN4018 with cemiplimab
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Assessment method [22]
0
0
Dose Expansion Phase
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Timepoint [22]
0
0
Up to 62 weeks
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Secondary outcome [23]
0
0
Time to deterioration in abdominal symptoms for REGN4018 monotherapy
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Assessment method [23]
0
0
Dose Expansion Phase
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Timepoint [23]
0
0
Up to 62 weeks
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Secondary outcome [24]
0
0
Time to deterioration in abdominal symptoms for REGN4018 with cemiplimab
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Assessment method [24]
0
0
Dose Expansion Phase
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Timepoint [24]
0
0
Up to 62 weeks
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Secondary outcome [25]
0
0
Change from baseline in QoL as measured by EQ-5D for REGN4018 monotherapy
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Assessment method [25]
0
0
Dose Expansion Phase
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Timepoint [25]
0
0
Baseline up to 62 weeks
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Secondary outcome [26]
0
0
Change from baseline in QoL as measured by EQ-5D for REGN4018 with cemiplimab
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Assessment method [26]
0
0
Dose Expansion Phase
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Timepoint [26]
0
0
Baseline up to 62 weeks
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Secondary outcome [27]
0
0
ORR based on iRECIST for REGN4018 monotherapy
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Assessment method [27]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [27]
0
0
Up to 62 weeks
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Secondary outcome [28]
0
0
ORR based on iRECIST for REGN4018 with cemiplimab
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Assessment method [28]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [28]
0
0
Up to 62 weeks
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Secondary outcome [29]
0
0
Best overall response (BOR) based on RECIST 1.1 for REGN4018 monotherapy
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Assessment method [29]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [29]
0
0
Up to 62 weeks
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Secondary outcome [30]
0
0
BOR based on iRECIST for REGN4018 monotherapy
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Assessment method [30]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [30]
0
0
Up to 62 weeks
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Secondary outcome [31]
0
0
BOR based on RECIST 1.1 for REGN4018 with cemiplimab
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Assessment method [31]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [31]
0
0
Up to 62 weeks
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Secondary outcome [32]
0
0
BOR based on iRECIST for REGN4018 with cemiplimab
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Assessment method [32]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [32]
0
0
Up to 62 weeks
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Secondary outcome [33]
0
0
Duration of response (DOR) based on RECIST 1.1 for REGN4018 monotherapy
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Assessment method [33]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [33]
0
0
Up to 62 weeks
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Secondary outcome [34]
0
0
DOR based on iRECIST for REGN4018 monotherapy
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Assessment method [34]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [34]
0
0
Up to 62 weeks
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Secondary outcome [35]
0
0
DOR based on RECIST 1.1 for REGN4018 with cemiplimab
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Assessment method [35]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [35]
0
0
Up to 62 weeks
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Secondary outcome [36]
0
0
DOR based on iRECIST for REGN4018 with cemiplimab
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Assessment method [36]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [36]
0
0
Up to 62 weeks
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Secondary outcome [37]
0
0
Disease control rate based on RECIST 1.1 for REGN4018 monotherapy
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Assessment method [37]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [37]
0
0
Up to 62 weeks
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Secondary outcome [38]
0
0
Disease control rate based on iRECIST for REGN4018 monotherapy
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Assessment method [38]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [38]
0
0
Up to 62 weeks
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Secondary outcome [39]
0
0
Disease control rate based on RECIST 1.1 for REGN4018 with cemiplimab
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Assessment method [39]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [39]
0
0
Up to 62 weeks
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Secondary outcome [40]
0
0
Disease control rate based on iRECIST for REGN4018 with cemiplimab
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Assessment method [40]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [40]
0
0
Up to 62 weeks
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Secondary outcome [41]
0
0
Complete response (CR) rate based on RECIST 1.1 for REGN4018 monotherapy
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Assessment method [41]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [41]
0
0
Up to 62 weeks
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Secondary outcome [42]
0
0
CR rate based on iRECIST 1.1 for REGN4018 monotherapy
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Assessment method [42]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [42]
0
0
Up to 62 weeks
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Secondary outcome [43]
0
0
CR rate based on RECIST 1.1 for REGN4018 with cemiplimab
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Assessment method [43]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [43]
0
0
Up to 62 weeks
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Secondary outcome [44]
0
0
CR rate based on iRECIST 1.1 for REGN4018 with cemiplimab
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Assessment method [44]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [44]
0
0
Up to 62 weeks
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Secondary outcome [45]
0
0
Progression-free survival (PFS) based on RECIST 1.1 for REGN4018 monotherapy
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Assessment method [45]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [45]
0
0
Up to 62 weeks
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Secondary outcome [46]
0
0
PFS based on iRECIST for REGN4018 monotherapy
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Assessment method [46]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [46]
0
0
Up to 62 weeks
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Secondary outcome [47]
0
0
PFS based on RECIST 1.1 for REGN4018 with cemiplimab
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Assessment method [47]
0
0
Dose Escalation and Dose Expansion Phases
Query!
Timepoint [47]
0
0
Up to 62 weeks
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Secondary outcome [48]
0
0
PFS based on iRECIST for REGN4018 with cemiplimab
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Assessment method [48]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [48]
0
0
Up to 62 weeks
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Secondary outcome [49]
0
0
Cancer antigen-125 (CA-125) response for REGN4018 monotherapy
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Assessment method [49]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [49]
0
0
Up to 62 weeks
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Secondary outcome [50]
0
0
CA-125 response for REGN4018 with cemiplimab
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Assessment method [50]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [50]
0
0
Up to 62 weeks
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Secondary outcome [51]
0
0
Presence or absence of anti-drug antibodies against REGN4018
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Assessment method [51]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [51]
0
0
Up to 62 weeks
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Secondary outcome [52]
0
0
Presence or absence of anti-drug antibodies against cemiplimab
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Assessment method [52]
0
0
Dose Escalation and Dose Expansion Phases
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Timepoint [52]
0
0
Up to 62 weeks
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Eligibility
Key inclusion criteria
Key
1. Ovarian Cancer Cohorts Only: Patients with histologically or cytologically confirmed
diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary
peritoneal, or fallopian tube cancer who have all of the following:
1. serum CA-125 level =2 x upper limit of normal (ULN) (in screening)
2. has received at least 1 line of platinum-containing therapy or must be
platinum-intolerant (applicable for dose escalation and non-randomized dose
expansion cohorts)
3. documented relapse or progression on or after the most recent line of therapy
4. no standard therapy options likely to convey clinical benefit
2. Adequate organ and bone marrow function as defined in the protocol
3. Life expectancy of at least 3 months
4. Randomized phase 2 expansion cohort (Ovarian Cancer only): Platinum-resistant ovarian
cancer patients who have had 1 to 3 lines of platinum-based therapy as defined in the
protocol.
5. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has
progressed or recurrent after prior anti-Programmed Cell Death Ligand 1 (PD-1) therapy
and platinum-based chemotherapy:
1. MUC16 positivity of tumor cells =25% by immunohistochemistry (IHC)
2. 1-2 prior lines of systemic therapy
Key
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in
the protocol
2. Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic
chemotherapy
3. Prior treatment with a MUC16 - targeted therapy
4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, or
spinal cord compression, as described in the protocol
5. History and/or current cardiovascular disease, as defined in the protocol
6. Severe and/or uncontrolled hypertension at screening. Patients taking
anti-hypertensive medication must be on a stable anti-hypertensive regimen
Note: Other protocol Inclusion/Exclusion Criteria apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/05/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
21/06/2026
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Actual
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Sample size
Target
690
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
0
0
Prince of Wales Hospital - Randwick
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Recruitment hospital [2]
0
0
Peter MacCallum Cancer Center - Melbourne
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Recruitment postcode(s) [1]
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NSW 2031 - Randwick
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3000 - Melbourne
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Recruitment outside Australia
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United States of America
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Alabama
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Massachusetts
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Minnesota
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New York
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Ohio
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Oklahoma
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Tennessee
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Virginia
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Belgium
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Antwerp
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Belgium
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Hainaut
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Belgium
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Vlaams Brabant
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France
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Bourgogne
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France
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Cedex 2
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France
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Lyon
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France
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Bordeaux
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France
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France
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Villejuif Cedex
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Israel
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Haifa
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Israel
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Tel Hashomer
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Italy
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Lazio
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Italy
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Milano
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Italy
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Naples
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Korea, Republic of
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Seoul
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Netherlands
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Gelderland
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Netherlands
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Zuid Holland
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Netherlands
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Groningen
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Spain
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Navarra
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Spain
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Navarre
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Santiago de Compostela
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United Kingdom
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England
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United Kingdom
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Greater Manchester
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United Kingdom
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London
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United Kingdom
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Oxfordshire
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United Kingdom
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Surrey
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Regeneron Pharmaceuticals
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Address
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Ethics approval
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Summary
Brief summary
The main purpose of this study is to:
- Learn about the safety of REGN4018 and to find out what dose of REGN4018 can be given
alone or with cemiplimab to patients with ovarian cancer or cancer of the uterus
- The study will also look at the levels of REGN4018 and/or cemiplimab in your body and
measure how well your body can remove the study drug(s). This is called pharmacokinetics
- The study will also look at any signs that REGN4018 alone or with cemiplimab can treat
recurrent advanced ovarian cancer or cancer of the uterus
- To find out how safe and tolerable the sarilumab pretreatment is, in combination with
REGN4018 and cemiplimab
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03564340
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Clinical Trial Management
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Address
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Regeneron Pharmaceuticals
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Contact person for public queries
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Clinical Trials Administrator
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Address
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Phone
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844-734-6643
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03564340
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