A Phase 2 interventional study of cemiplimab and Fixed Dose Combination (FDC) cemiplimab+fianlimab in Melanoma, sponsored by Regeneron Pharmaceuticals. Active, not recruiting at 104 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Regeneron Pharmaceuticals · Phase 2, Interventional, and Treatment
This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with cemiplimab alone. These types of immunotherapy study drugs are collectively known as immune checkpoint inhibitors. Immunotherapies are treatments that use the immune system to recognize and kill cancer cells. The study is focused on participants with a type of skin cancer known as melanoma.
The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to cemiplimab in participants with high-risk, resectable melanoma. Participants will receive treatment before surgery, undergo resection, and then will have the option to continue treatment after resection.
The study is looking at several other research questions, including:
3,006 studies on the registry are indexed under Melanoma; 519 are open to participants now.
This study's enrollment of 151 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.
Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Medical conditions:
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 as described in the protocol.
Prior/concomitant therapy:
Treatment with any anti-cancer therapy for malignancies other than melanoma, including immuno- therapy, chemotherapy, radiotherapy, or biological therapy in the 5 years prior to randomization as described in the protocol.
Other comorbidities:
Note: Other protocol-defined inclusion/ exclusion criteria apply
As described in the protocol
Drug: cemiplimab · Drug: Placebo
As described in the protocol
Drug: Fixed Dose Combination (FDC) cemiplimab+fianlimab
As described in the protocol
Drug: Fixed Dose Combination (FDC) cemiplimab+fianlimab
Administered per the protocol
Also known as: REGN2810, Libtayo
Or coadministration, depending on availability.
Also known as: REGN2810, Libtayo, REGN3767
Administered per the protocol
Pathological complete response (pCR) rate as assessed by Blinded Independent Pathological Review (BIPR)
Time frame: Up to 1 year
pCR rate as assessed by local pathologic review
Time frame: Up to 1 year
Event-Free Survival (EFS)
Time frame: Up to 4 years
Distant metastasis-free survival (DMFS)
Time frame: Up to 4 years
Overall survival (OS)
Time frame: Up to 4 years
Major pathological response (MPR) as assessed by BIPR
Time frame: Up to 4 years
MPR rate as assessed by local pathologic review
Time frame: Up to 4 years
Objective Response Rate (ORR) assessed by investigator per RECIST 1.1 criteria
Time frame: Up to 4 years
ORR assessed by Blinded Independent Central Review (BICR) per RECIST 1.1 criteria
Time frame: Up to 4 years
Relapse-free survival (RFS)
Time frame: Up to 4 years
Occurrence of treatment-emergent adverse events (TEAEs)
Time frame: 90 days following last dose of study drug, approximately 4 years
Occurrence of immune-mediated adverse events (imAEs)
Time frame: 90 days following last dose of study drug, approximately 4 years
Occurrence of serious adverse events (SAEs)
Time frame: 90 days following last dose of study drug, approximately 4 years
Occurrence of adverse events of special interest (AESIs)
Time frame: 90 days following last dose of study drug, approximately 4 years
Occurrence of TEAEs resulting in death
Time frame: 90 days following last dose of study drug, approximately 4 years
Occurrence of interruption or discontinuation of study drug(s) due to TEAE.
Time frame: 90 days following last dose of study drug, approximately 4 years
Occurrence of cancellation of surgery due to TEAE or delay to surgery
Time frame: 90 days following last dose of study drug, approximately 4 years
Occurrence of laboratory abnormalities
Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)
Time frame: 90 days following last dose of study drug, approximately 4 years
Concentrations of fianlimab in serum
Time frame: Up to 4 years
Concentrations of cemiplimab in serum
Time frame: Up to 4 years
Anti-drug antibodies (ADA) in serum to fianlimab
Time frame: Up to 4 years
ADA in serum to cemiplimab
Time frame: Up to 4 years
Change from baseline in disease-related symptoms per Functional Assessment of Cancer Therapy-Melanoma (FACT-M) subscale
The FACT-M is a melanoma-specific quality of life questionnaire that is composed of items from the Functional Assessment of Cancer Therapy-General (FACT-G). The FACT-M 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).
Time frame: Up to 4 years
Change from baseline in functioning per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QoL) C30 (EORTC QLQ-C30)
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.
Time frame: Up to 4 years
Change from baseline in global health status/QoL per EORTC QLQ-C30
Time frame: Up to 4 years
Change from baseline in overall health state per European Quality of Life Dimension 5 (EQ-5D-5L)
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.
Time frame: Up to 4 years
Showing the first 100 of 104 sites across 8 countries.
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Regeneron Pharmaceuticals