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 · tracked via the Priya Life Science UK tracker

Sponsor

Regeneron Pharmaceuticals

Phase

Phase 3

Started

2023-01-16

Last updated

2026-07-06

Condition(s) studied

Melanoma

Investigational drug(s) / intervention(s)

FianlimabCemiplimabPembrolizumabPlacebo

Fianlimab: Fianlimab will be administered by intravenous (IV) infusion every (Q) 3 weeks

Cemiplimab: Cemiplimab will be administered by IV infusion Q 3 weeks

Pembrolizumab: Pembrolizumab will be administered by IV infusion Q 3 weeks

Placebo: Matching placebo co-infused with pembrolizumab IV, will be administered by IV infusion Q 3 weeks

Study 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.

Eligibility

Sex

ALL

Min age

12 Years

Max age

—

Healthy volunteers

Key Inclusion Criteria: 1. 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 2. Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery 3. 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: 1. Uveal melanoma 2. Any evidence of residual disease after surgery by imaging, pathology, or cytology. 3. Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required treatment 4. 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 5. Another malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocol 6. Participants with a history of myocarditis 7. Adolescent patients (≥12 to \<18 years old) with body weight \<40 kg Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Primary outcome measure(s)

Relapse free survival (RSF) — Up to 5 Years
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.

Trial sites (211)

Facility	City	Region
UC San Diego	La Jolla	California
UCSF Medical Center at Mission Bay	San Francisco	California
John Wayne Cancer Institute (JWCI)	Santa Monica	California
The Melanoma And Skin Cancer Institute	Englewood	Colorado
Miami Cancer Institute at Baptist Health, Inc.	Miami	Florida
Orlando Health	Orlando	Florida
Moffitt Cancer Center	Tampa	Florida
Northwestern University	Chicago	Illinois
Massachusetts General Hospital	Boston	Massachusetts
Dana-Farber Cancer Institute	Boston	Massachusetts
Karmanos Cancer Institute	Detroit	Michigan
Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health	New York	New York
Columbia University	New York	New York
University of Rochester	Rochester	New York
Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina
Duke Cancer Institute, University Hospital	Durham	North Carolina
University Hospitals Cleveland Medical Center	Cleveland	Ohio
Cleveland Clinic Foundation	Cleveland	Ohio
The Ohio State University James Comprehensive Cancer Center	Columbus	Ohio
St Lukes University Health Network	Easton	Pennsylvania
University Of Pittsburgh	Pittsburgh	Pennsylvania
University of Tennessee Medical Center	Knoxville	Tennessee
Tennessee Oncology - Centennial Clinic Location	Nashville	Tennessee
Verdi Oncology	Nashville	Tennessee
UT Southwestern Medical Center	Dallas	Texas
Intermountain Medical Center	Murray	Utah
University of Virginia Medical Center	Charlottesville	Virginia
Fundacion Centro de Investigaciones para la Transformacion (CENIT)	Caba	Buenos Aires
Centro de Investigacion Pergamino	Pergamino	Buenos Aires
Clinica Viedma S.A.	Viedma	Río Negro Province
Instituto de Oncologia de Rosario	Rosario	Santa Fe Province
Centro Medico San Roque	San Miguel de Tucumán	Tucumán Province
DIABAID - Instituto de Asistencia Integral en Diabetes	Caba	Argentina
Blacktown Cancer and Haematology Centre - Blacktown Hospital	Blacktown	New South Wales
Lismore Base Hospital	Lismore	New South Wales
Liverpool Hospital - Cancer Therapy Centre	Liverpool	New South Wales
Melanoma Institute of Australia	Wollstonecraft	New South Wales
Flinders Medical Centre	Bedford Park	South Australia
Calvary North Adelaide Hospital	North Adelaide	South Australia

+ 171 more sites — see the full list on the official registry below.

On this site

📄 Libtayo (cemiplimab) drug profile → 📄 Keytruda (pembrolizumab) drug profile →

More Regeneron Pharmaceuticals trials in the UK

A Study in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate How Safe Long-term Treatment With Pozelimab + Cemdisiran Combination Therapy is and How Well it Works Recruiting

A Study to Test the Safety, Tolerability, and Efficacy of an Antibody, REGN7999, Injected Under the Skin for the Treatment of Iron Overload in Adult Participants With Non-Transfusion Dependent β-thalassemia, Using MRI Scans to Measure Iron Levels in the Body Active, not recruiting

A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis) Recruiting

A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy Recruiting

A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma Recruiting

Other trials for the same condition

Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma. Recruiting

A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001) Active, not recruiting

A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition Active, not recruiting

Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. Active, not recruiting

Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05608291 on ClinicalTrials.gov ↗ ← All trials in the UK