A Trial to See if the Combination of Fianlimab With Cemip... | NCT05608291

Studies
A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery

NCT05608291

Sponsor

Regeneron Pharmaceuticals

Status

Active, not recruiting

Last Update Posted

Jul 6, 2026Actual

Enrollment

1,564Actual

Phase

Phase 3

Conditions

Melanoma

Interventions

Fianlimab
Cemiplimab
Pembrolizumab
Placebo

Countries

United States
Argentina
Australia
Belgium
Brazil
Canada
Chile
Czechia
France
Georgia
Germany
Greece
Ireland
Israel
Italy
Mexico
Poland
Romania
South Africa
Spain
Turkey (Türkiye)
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2022-501576-25-00	Registry Identifier	EUCT Number

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 16, 2023Actual

Primary Completion Date

Jul 27, 2026Estimated

Completion Date

Apr 3, 2030Estimated

First Submitted Date

Oct 14, 2022

First Submission Date that Met QC Criteria

Oct 31, 2022

First Posted Date

Nov 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2026

Last Update Posted Date

Jul 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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 an approved medication called pembrolizumab.

The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in patients that have had melanoma removal surgery but are still at high risk for the recurrence of the disease. Pembrolizumab is an approved treatment in some countries in this clinical setting.

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 drug (which could make the drug 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,564Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fianlimab HD + Cemiplimab	Experimental	Patients will be administered one combination dose of fianlimab high dose (HD) and cemiplimab	Drug: Fianlimab Drug: Cemiplimab
Fianlimab LD + Cemiplimab	Experimental	Patients will be administered one combination dose of fianlimab low dose (LD) and cemiplimab	Drug: Fianlimab Drug: Cemiplimab
Pembrolizumab	Active Comparator	Patients will be administered one dose of pembrolizumab co-infused with saline/dextrose placebo	Drug: Pembrolizumab Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fianlimab	Drug	Fianlimab will be administered by intravenous (IV) infusion every (Q) 3 weeks	Fianlimab HD + Cemiplimab Fianlimab LD + Cemiplimab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relapse free survival (RSF)	Time from randomization to the first documented recurrence of disease at any site (excluding new primary melanomas) or death from any cause, whichever occurs first.	Up to 5 Years

Secondary Outcomes

Measure	Description	Time Frame
Distant metastasis-free survival (DMFS)	Time between the date of randomization and the date of the first distant metastasis.	Up to 5 Years
Overall survival (OS)	Time from randomization to the date of death.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

All patients must be either stage IIB, IIC, III, or stage IV per American Joint Committee on Cancer (AJCC) 8th edition and have histologically confirmed melanoma that is completely surgically resected in order to be eligible as defined by the protocol
Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery
All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization, as described in the protocol

Key Exclusion Criteria:

Uveal melanoma
Any evidence of residual disease after surgery by imaging, pathology, or cytology.
Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required treatment
Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol
Another malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocol
Participants with a history of myocarditis
Adolescent patients (≥12 to <18 years old) with body weight <40 kg

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Trial Management	Regeneron Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
UC San Diego		La Jolla	California	92093	United States
UCSF Medical Center at Mission Bay

Label	URL
A clinical study for adults and adolescents who are melanoma-free following surgery.	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

When Regeneron has:

received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
the legal authority to share the data, and
ensured the ability to protect participant privacy.

Access Criteria

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

URL

https://vivli.org/

ID	Term
D008545	Melanoma
D012878	Skin Neoplasms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009380	Neoplasms, Nerve Tissue
D018326	Nevi and Melanomas
D009371	Neoplasms by Site
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases