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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/NCT05352672
Registration number
NCT05352672
Ethics application status
Date submitted
6/04/2022
Date registered
29/04/2022
Date last updated
22/02/2024
Titles & IDs
Public title
Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
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Scientific title
A Phase 2 and Phase 3 Trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
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Secondary ID [1]
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2021-004453-23
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Secondary ID [2]
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R3767-ONC-2011
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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:
Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Fianlimab
Treatment: Drugs - Cemiplimab
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Placebo
Experimental: A: fianlimab+cemiplimab dose 1 - Phase 2 and Phase 3
Experimental: A1: fianlimab+cemiplimab dose 2 - Phase 2 and Phase 3 (except for PA1 patients as described in the protocol)
Experimental: B: pembrolizumab+placebo - Phase 2 and Phase 3
Experimental: C: cemiplimab+placebo - Phase 2 (as described in the protocol)
Treatment: Drugs: Fianlimab
Intravenous (IV) infusion
Treatment: Drugs: Cemiplimab
IV infusion
Treatment: Drugs: Pembrolizumab
IV infusion
Treatment: Drugs: Placebo
IV infusion
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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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Objective response rate (ORR)
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Assessment method [1]
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Phase 2 Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Blinded Independent Central Review (BICR)
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Timepoint [1]
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Approximately 27 months
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Primary outcome [2]
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Progression-free survival (PFS)
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Assessment method [2]
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Phase 3 Per RECIST 1.1 based on BICR
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Timepoint [2]
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Approximately 27 months
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Secondary outcome [1]
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PFS
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Assessment method [1]
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Per RECIST 1.1 based on BICR or investigator assessment according to RECIST 1.1 and immune RECIST (iRECIST)
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Timepoint [1]
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Up to 27 months
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Secondary outcome [2]
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Overall survival (OS)
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Assessment method [2]
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Timepoint [2]
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Up to 96 months
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Secondary outcome [3]
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ORR
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Assessment method [3]
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Per RECIST 1.1 based on BICR or investigator assessment according to RECIST 1.1 and iRECIST
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Timepoint [3]
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Up to 27 months
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Secondary outcome [4]
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Disease control rate (DCR)
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Assessment method [4]
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Per RECIST 1.1 based on BICR or investigator assessment according to RECIST 1.1 and iRECIST
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Timepoint [4]
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Up to 27 months
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Secondary outcome [5]
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Duration of response (DoR)
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Assessment method [5]
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Per RECIST 1.1 based on BICR or investigator assessment according to RECIST 1.1 and iRECIST
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Timepoint [5]
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Up to 27 months
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Secondary outcome [6]
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Incidence of Adverse Events (AEs)
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Assessment method [6]
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Including treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and/ or immune-related adverse event (imAEs)
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Timepoint [6]
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Up to 90 days post last dose, approximately 6 years
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Secondary outcome [7]
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Occurrence of interruption and discontinuation of study drug(s) due to AEs
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Assessment method [7]
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Including TEAEs, AESIs, and/ or imAEs
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Timepoint [7]
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Up to 90 days post last dose, approximately 6 years
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Secondary outcome [8]
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Incidence of deaths related to TEAEs
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Assessment method [8]
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0
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Timepoint [8]
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Up to 6 years
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Secondary outcome [9]
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Incidence of laboratory abnormalities
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Assessment method [9]
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Will be graded using the current version of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading system (version 5.0)
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Timepoint [9]
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Up to 90 days post last dose, approximately 6 years
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Secondary outcome [10]
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Concentrations of cemiplimab in serum
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Assessment method [10]
0
0
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Timepoint [10]
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Up to 90 days post last dose, approximately 6 years
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Secondary outcome [11]
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Concentrations of fianlimab in serum
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Assessment method [11]
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Timepoint [11]
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Up to 90 days post last dose, approximately 6 years
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Secondary outcome [12]
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Incidence of anti-drug antibodies (ADA) to fianlimab over time
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Assessment method [12]
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Timepoint [12]
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Up to 30 days post last dose, approximately 6 years
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Secondary outcome [13]
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Titer of anti-drug antibodies (ADA) to fianlimab over time
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Assessment method [13]
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0
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Timepoint [13]
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Up to 30 days post last dose, approximately 6 years
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Secondary outcome [14]
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Incidence of ADA to cemiplimab over time
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Assessment method [14]
0
0
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Timepoint [14]
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Up to 30 days post last dose, approximately 6 years
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Secondary outcome [15]
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Titer of ADA to cemiplimab over time
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Assessment method [15]
0
0
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Timepoint [15]
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Up to 30 days post last dose, approximately 6 years
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Secondary outcome [16]
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Incidence of neutralizing antibodies (NAb) to fianlimab over time
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Assessment method [16]
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Timepoint [16]
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Up to 30 days post last dose, approximately 6 years
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Secondary outcome [17]
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Incidence of NAb to cemiplimab over time
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Assessment method [17]
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0
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Timepoint [17]
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Up to 30 days post last dose, approximately 6 years
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Secondary outcome [18]
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Patient-reported outcomes (PROs) as measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)
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Assessment method [18]
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EORTC-QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
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Timepoint [18]
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Up to 90 days post last dose, approximately 6 years
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Secondary outcome [19]
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PROs as measured by EQ-5D-5L
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Assessment method [19]
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The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Overall scores range from 0 to 1, with low scores representing a higher level of dysfunction.
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Timepoint [19]
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Up to 90 days post last dose, approximately 6 years
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Secondary outcome [20]
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PROs as measured by Functional Assessment of Cancer Therapy melanoma (FACTM) (melanoma subscale only)
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Assessment method [20]
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The FACTM is a melanoma-specific quality of life questionnaire that is composed of items from the Functional Assessment of Cancer Therapy-General (FACT-G). The FACTM is scored on a 5 point Likert-scale: "Not at all", "A little bit", "Somewhat", "Quite a bit", and "Very much.". A Higher score represents higher Health Related Quality of Life (HRQoL).
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Timepoint [20]
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Up to 90 days post last dose, approximately 6 years
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Secondary outcome [21]
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PROs as measured by Patient Global Impression of Severity (PGIS)
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Assessment method [21]
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The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe".
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Timepoint [21]
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Up to 21 days post last dose, approximately 6 years
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Secondary outcome [22]
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PROs as measured by Patient Global Impression of Change (PGIC)
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Assessment method [22]
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The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change"
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Timepoint [22]
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Up to 21 days post last dose, approximately 6 years
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Secondary outcome [23]
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Change in physical functioning per EORTC QLQ-C30
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Assessment method [23]
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0
EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
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Timepoint [23]
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Baseline to Week 25
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Secondary outcome [24]
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Change in role functioning per EORTC QLQ-C30
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Assessment method [24]
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0
EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
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Timepoint [24]
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Baseline to Week 25
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Secondary outcome [25]
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Change in global health status/quality of life (GHS/QoL) per EORTC QLQ-C30
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Assessment method [25]
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Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
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Timepoint [25]
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0
Baseline to Week 25
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Secondary outcome [26]
0
0
Change in physical functioning per EORTC QLQ-C30
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Assessment method [26]
0
0
EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
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Timepoint [26]
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Baseline to end of study, approximately 6 years
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Secondary outcome [27]
0
0
Change in role functioning per EORTC QLQ-C30
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Assessment method [27]
0
0
EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
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Timepoint [27]
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0
Baseline to end of study, approximately 6 years
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Secondary outcome [28]
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Change in GHS/QoL per EORTC QLQ-C30
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Assessment method [28]
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0
EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
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Timepoint [28]
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Baseline to end of study, approximately 6 years
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Eligibility
Key inclusion criteria
Key
1. Age =12 years on the date of providing informed consent
2. Patients with histologically confirmed unresectable Stage III and Stage IV
(metastatic) melanoma (AJCC, 8th revised edition) who have not received prior systemic
therapy for advanced unresectable disease
1. Patients who received adjuvant and/or neoadjuvant systemic therapies are eligible
if they did not have evidence of progression or recurrence of disease and/or
discontinued due to occurrence of unmanageable imAEs = grade 3 (with the
exclusion of endocrinopathies which are fully controlled by hormone replacement)
while on such therapies. Also, patients must have had a treatment-free and
disease-free interval of >6 months. Accrual of these patients is limited to
approximately 10% of the total population enrolled in each of the Phase 2 and
Phase 3 parts of the study.
2. Patients with acral and mucosal melanomas are eligible. Combined accrual will be
limited to 10% of the total population enrolled in the Phase 3 part of the study.
3. Measurable disease per RECIST v1.1
1. Previously irradiated lesions can only be counted as target lesions if they have
been demonstrated to progress and no other target lesion is available
2. Cutaneous lesions should be evaluated as non-target lesions
4. Performance status:
1. For adult patients: Eastern Cooperative Oncology Group (ECOG) performance status
(PS) 0 or 1
2. For pediatric patients: Karnofsky performance status =70 (patients =16 years) or
Lansky performance status =70 (patients =16 years)
5. Anticipated life expectancy of at least 3 months
Key
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Uveal melanoma
2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required
systemic treatment with immunosuppressive agents. The following are non-exclusionary:
vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires
only hormone replacement, psoriasis not requiring systemic treatment.
3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or
hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related
to, or results in chronic infection
4. Unknown v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status as
described in the protocol
5. Systemic immune suppression:
1. Use of immunosuppressive doses of corticosteroids (>10mg of prednisone per day or
equivalent) within 14 days of the first dose of study medication. Physiologic
replacement doses are allowed up to and including 10mg of prednisone/day or
equivalent. Inhaled or topical steroids are permitted, if they are not for
treatment of an autoimmune disorder.
2. Other clinically relevant forms of systemic immune suppression
6. Treatment with other anti-cancer therapy including immuno- therapy, chemotherapy,
major surgery or biological therapy within 21 days prior to the first dose of trial
treatment. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive
cancers in long term remission is allowed.
7. History or current evidence of significant (CTCAE Grade =2) local or systemic
infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic
treatment within 14 days prior to the first dose of trial medication.
8. Participants with a history of myocarditis.
9. Active or untreated brain metastases or spinal cord compression. Patients with
leptomeningeal disease are excluded. Patients with known brain metastases are eligible
if they:
1. Received radiotherapy or another appropriate standard therapy for the brain
metastases,
2. Have neurologically returned to baseline (except for residual signs and symptoms
related to the CNS treatment) for at least 14 days prior to enrollment
3. Did not require immunosuppressive doses of corticosteroids therapy (>10mg of
prednisone per day or equivalent) in the 14 days prior to enrollment
4. Are asymptomatic with a single untreated brain metastasis <10 mm in size
Note: Other protocol-defined Inclusion/ Exclusion criteria apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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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
14/07/2022
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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
31/08/2032
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Actual
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Sample size
Target
1925
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Calvary North Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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Barwon Health Andrew Love Cancer Centre, University Hospital Geelong - Geelong
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Recruitment hospital [3]
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Icon Cancer Centre Hobart - Hobart
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Recruitment hospital [4]
0
0
The Alfred Hospital - Melbourne
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Recruitment hospital [5]
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Gold Coast University Hospital - Southport
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Recruitment hospital [6]
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The Townsville Hospital and Health Service - Townsville
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Recruitment hospital [7]
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Ballarat Oncology and Haematology Clinical Trials Unit - Wendouree
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Recruitment postcode(s) [1]
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05006 - Adelaide
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Recruitment postcode(s) [2]
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03220 - Geelong
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Recruitment postcode(s) [3]
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7000 - Hobart
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Recruitment postcode(s) [4]
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03004 - Melbourne
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Recruitment postcode(s) [5]
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0
4215 - Southport
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Recruitment postcode(s) [6]
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04814 - Townsville
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Recruitment postcode(s) [7]
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03355 - Wendouree
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Florida
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Country [3]
0
0
United States of America
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State/province [3]
0
0
New Jersey
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Ohio
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Tennessee
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Country [6]
0
0
Argentina
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State/province [6]
0
0
Buenos Aires
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Country [7]
0
0
Argentina
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State/province [7]
0
0
Caba
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Country [8]
0
0
Argentina
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State/province [8]
0
0
Ciudad Autonoma de Buenos Aires
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Country [9]
0
0
Argentina
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State/province [9]
0
0
Rosario
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Country [10]
0
0
Argentina
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State/province [10]
0
0
San Miguel de Tucuman
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Country [11]
0
0
Austria
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State/province [11]
0
0
Tyrol
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Country [12]
0
0
Austria
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State/province [12]
0
0
Graz
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Country [13]
0
0
Austria
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State/province [13]
0
0
St. Poelten
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Country [14]
0
0
Austria
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State/province [14]
0
0
Vienna
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Country [15]
0
0
Belgium
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State/province [15]
0
0
Brussels
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Country [16]
0
0
Belgium
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State/province [16]
0
0
Kortrijk
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Country [17]
0
0
Belgium
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State/province [17]
0
0
Namur
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Country [18]
0
0
Belgium
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State/province [18]
0
0
Sint Niklaas
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Country [19]
0
0
Brazil
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State/province [19]
0
0
Barretos
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Country [20]
0
0
Brazil
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State/province [20]
0
0
Belo Horizonte
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Country [21]
0
0
Brazil
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State/province [21]
0
0
Curitiba
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Country [22]
0
0
Brazil
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State/province [22]
0
0
Ijui
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Country [23]
0
0
Brazil
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State/province [23]
0
0
Itajai
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Country [24]
0
0
Brazil
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State/province [24]
0
0
Joinville
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Country [25]
0
0
Brazil
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State/province [25]
0
0
Lages
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Country [26]
0
0
Brazil
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State/province [26]
0
0
Lajeado
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Country [27]
0
0
Brazil
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State/province [27]
0
0
Passo Fundo
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Country [28]
0
0
Brazil
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State/province [28]
0
0
Porto Alegre
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Country [29]
0
0
Brazil
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State/province [29]
0
0
Porto Velho
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Country [30]
0
0
Brazil
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State/province [30]
0
0
Rio de Janeiro
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Country [31]
0
0
Brazil
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State/province [31]
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0
Salvador
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Country [32]
0
0
Brazil
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State/province [32]
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0
Santo Cristo
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Country [33]
0
0
Brazil
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State/province [33]
0
0
Sao Jose do Rio Preto
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Country [34]
0
0
Brazil
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State/province [34]
0
0
Sao paulo
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Country [35]
0
0
Brazil
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State/province [35]
0
0
Sao Paulo
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Country [36]
0
0
Canada
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State/province [36]
0
0
Ontario
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Country [37]
0
0
Canada
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State/province [37]
0
0
Barrie
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Country [38]
0
0
Canada
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State/province [38]
0
0
Edmonton
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Country [39]
0
0
Canada
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State/province [39]
0
0
Fredericton
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Country [40]
0
0
Canada
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State/province [40]
0
0
Saskatoon
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Country [41]
0
0
Canada
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State/province [41]
0
0
Toronto
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Country [42]
0
0
Chile
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State/province [42]
0
0
Chi
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Country [43]
0
0
Chile
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State/province [43]
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0
Region Metropolitana De Santiago
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Country [44]
0
0
Chile
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State/province [44]
0
0
Antofagasta
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Country [45]
0
0
Chile
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Santiago
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Chile
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Vina del Mar
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Czechia
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Hradec Kralove
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Czechia
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Ostrava
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Czechia
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Prague 10
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France
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Besancon Cedex
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France
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Bobigny
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France
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Bordeaux Cedex
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France
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Boulogne Billancourt
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France
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Clermont-Ferrand
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France
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Creteil
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France
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Dijon
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France
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Grenoble
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France
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Le Mans
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France
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Lille Cedex
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France
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Lyon cedex 08
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France
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Nantes
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France
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Paris
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Country [63]
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France
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Pierre Benite Cedex
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Country [64]
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France
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Poitiers Cedex
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France
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Rouen
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France
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Saint-Etienne
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France
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Strasbourg
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France
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Villejuif Cedex
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Georgia
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Batumi
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Georgia
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Tbilisi
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Germany
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Augsburg
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Buxtehude
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Germany
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Dresden
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Germany
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Erfurt
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Germany
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Frankfurt
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Germany
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Giessen
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Country [79]
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Germany
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Göttingen
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Germany
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Kiel
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Country [81]
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Germany
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Leipzig
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Country [82]
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Germany
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Luebeck
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Germany
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Mannheim
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Germany
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Muenster
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Country [85]
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Germany
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Quedlinburg
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Country [86]
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Germany
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State/province [86]
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Regensburg
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Country [87]
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Germany
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State/province [87]
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Schwerin
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Country [88]
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Hungary
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State/province [88]
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Debrecen
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Country [89]
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Hungary
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State/province [89]
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Nyíregyhaza
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Country [90]
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Hungary
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State/province [90]
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Pecs
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Country [91]
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Hungary
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State/province [91]
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Szeged
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Ireland
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Cork
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Ireland
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Dublin 4
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Ireland
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Dublin
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Ireland
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Galway
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Country [96]
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Italy
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Bari
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Country [97]
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Italy
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Brescia
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Country [98]
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Italy
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Candiolo
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Country [99]
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Italy
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Cuneo
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Country [100]
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Italy
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Genova
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Country [101]
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Italy
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Monza
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Country [102]
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Italy
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Napoli
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Country [103]
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Italy
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Novara
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Country [104]
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Italy
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Padova
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Country [105]
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Italy
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Pisa
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Country [106]
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Italy
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Rome
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Country [107]
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Italy
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San Giovanni Rotondo
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Country [108]
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Italy
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Terni
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0
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Italy
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Trento
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Country [110]
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Italy
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Turin
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Country [111]
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Italy
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Udine
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Country [112]
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Mexico
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Chihuahua
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Country [113]
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Mexico
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Culiacan
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Country [114]
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Mexico
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Guadalajara
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Country [115]
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Mexico
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Leon
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Country [116]
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Mexico
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Merida
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Mexico
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Monterrey
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Mexico
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Mexico
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Veracruz
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Mexico
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Zapopan
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Amsterdam
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Netherlands
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Groningen
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Peru
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Arequipa
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Peru
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Bellavista
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Peru
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Concepcion
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Peru
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Lima
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Peru
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Trujillo
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Poland
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Gdansk
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Poland
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Krakow
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Poznan
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Poland
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Siedlce
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Poland
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Slupsk
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Country [133]
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Poland
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Warszawa
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Country [134]
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Romania
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Bucharest
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Country [135]
0
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Romania
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Cluj Napoca
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Romania
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Cluj-Napoca
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Romania
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Cluj
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Country [138]
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Romania
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Craiova
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Country [139]
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Romania
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Iasi
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Country [140]
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Romania
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State/province [140]
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Otopeni
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Country [141]
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Romania
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Timisoara
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Country [142]
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South Africa
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Cape Town
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Country [143]
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South Africa
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Johannesburg
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Country [144]
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South Africa
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Kraaifontein
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Country [145]
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Spain
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A Coruna
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Spain
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Badalona
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Spain
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Barcelona
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Country [148]
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Spain
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Cordoba
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Spain
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Girona
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Country [150]
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Spain
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Granada
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Country [151]
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Spain
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Lugo
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Country [152]
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Múrcia
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Spain
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Oviedo
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Country [156]
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Spain
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San Sebastian
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Country [157]
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Spain
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Sevilla
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Country [158]
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Spain
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Valencia
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Country [159]
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Turkey
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State/province [159]
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Adana
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Country [160]
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Turkey
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State/province [160]
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Ankara
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Country [161]
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Turkey
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State/province [161]
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Diyarbakir
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Country [162]
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Turkey
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Edirne
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Country [163]
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Turkey
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Gaziantep
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Country [164]
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Turkey
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Istanbul
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Country [165]
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Turkey
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Kocaeli
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Country [166]
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United Kingdom
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Devon
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Country [167]
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United Kingdom
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State/province [167]
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Guildford
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Country [168]
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United Kingdom
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State/province [168]
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Hull
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Country [169]
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United Kingdom
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State/province [169]
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Leeds
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Country [170]
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United Kingdom
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State/province [170]
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London
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is researching an experimental drug called REGN3767, also known as fianlimab
(R3767), when combined with another medication called REGN2810, also known as cemiplimab
(each individually called a "study drug" or called "study drugs" when combined). The study is
focused on patients with a type of skin cancer known as melanoma.
The aims of the study are to see how effective the combination of fianlimab and cemiplimab
are in treating the melanoma skin cancer, in comparison with a medication, pembrolizumab,
approved for the treatment of melanoma skin cancer in adults, and to observe any
similarities, or differences, in how the study drugs work in adolescent participants compared
with adult participants.
The study is looking at several other research questions, including:
- What side effects may happen from receiving the study drugs
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drugs (which could make the drugs
less effective or could lead to side effects). Antibodies are proteins that are
naturally found in the blood stream that fight infections.
- How administering the study drugs might improve quality of life
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05352672
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Clinical Trial Management
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Address
0
0
Regeneron Pharmaceuticals
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
Query!
Contact person for public queries
Name
0
0
Clinical Trials Administrator
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Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
844-734-6643
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Fax
0
0
Query!
Email
0
0
[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/NCT05352672
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