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

A Phase 3 Trial of Fianlimab (Anti-LAG-3) and Cemiplimab Versus Pembrolizumab in the Adjuvant Setting in Patients With Completely Resected High-risk Melanoma

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Melanoma
• Intervention / Treatment: Drug: Fianlimab; Drug: Cemiplimab; Drug: Pembrolizumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1564
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, 1061
    • DIABAID - Instituto de Asistencia Integral en Diabetes
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, 1125
      • Fundacion Centro de Investigaciones para la Transformacion (CENIT)
    • Pergamino, Buenos Aires, Argentina, B2700CPM
      • Centro de Investigación Pergamino
  • Rio Negro
    • Viedma, Rio Negro, Argentina, 8500
      • Clinica Viedma S.A.
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000KZE
      • Instituto de Oncología de Rosario
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, 4000
      • Centro Medico San Roque
• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Blacktown Cancer and Haematology Centre - Blacktown Hospital
    • Lismore, New South Wales, Australia, 2480
      • Lismore Base Hospital
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital - Cancer Therapy Centre
    • Wollstonecraft, New South Wales, Australia, 2065
      • Melanoma Institute of Australia
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
    • North Adelaide, South Australia, Australia, 5006
      • Calvary North Adelaide Hospital
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Eastern Health
    • Geelong, Victoria, Australia, 3220
      • Andrew Love Cancer Centre
    • Melbourne, Victoria, Australia, 3004
      • Alfred Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • One Clinical Research at Hollywood Private Hospital
• Belgium
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires Saint-Luc
  • Oost-Vlaanderen
    • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
      • Vitaz campus Sint-Niklaas Moerland
  • West-Vlaanderen
    • Kortrijk, West-Vlaanderen, Belgium, 8500
      • Az Groeninge
• Brazil
  • Rio de Janeiro, Brazil, 23793-080
    • Instituto Coi
  • Sao Paulo, Brazil, 01308-050
    • Hospital Sírio Libanês
  • Sao Paulo, Brazil, 01236030
    • Hemomed
  • Sao Paulo, Brazil, 04014-002
    • Sao Camilo Oncologia
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-090
      • Hospital das Clinicas da Universidade Federal de Minas Gerais
  • Parana
    • Curitiba, Parana, Brazil, 81520-060
      • Liga Paranaense de Combate ao Câncer - Hospital Erasto Gaertner
  • Rio De Janeiro
    • Santo Cristo, Rio De Janeiro, Brazil, 20220-410
      • Inca Instituto Nacional de Cancer
  • Rio Grande Do Sul
    • Ijui, Rio Grande Do Sul, Brazil, 98700-000
      • Oncosite Centro De Pesquisa Em Oncologia
    • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-090
      • Instituto do Cancer em Hospital Sao Vicente de Paulo
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035007
      • Hospital de Clinicas de Porto Alegre
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90440140
      • Hospital Moinhos de Vento
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90619900
      • Centro de Pesquisa em Oncologia PUCRS
  • Santa Catarina
    • Itajai, Santa Catarina, Brazil, 88301-220
      • Catarina Pesquisa Clinica
    • Joinville, Santa Catarina, Brazil, 89201260
      • Instituto Joinvilense de Hematologia e Oncologia
    • Lages, Santa Catarina, Brazil, 88501-001
      • Animi Unidade de Tratamento Oncologico
  • Sao Paulo
    • Barretos, Sao Paulo, Brazil, 14784400
      • Fundacao PIO XII - Hospital de Amor
    • Sao Jose do Rio Preto, Sao Paulo, Brazil, 15090-000
      • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
    • Sorocaba, Sao Paulo, Brazil, 18052-210
      • Unimed Sorocaba
• Canada
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 5N5
      • Dr. Everett Chalmers Hospital
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Royal Victoria Regional Health Centre
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
• Chile
  • Region Metropolitana
    • Santiago, Region Metropolitana, Chile, 7550000
      • Clínica UC San Carlos de Apoquindo
    • Santiago, Region Metropolitana, Chile, 7560907
      • Centro Oncologia de Precision Universidad Mayor
  • Valparaiso
    • Vina del Mar, Valparaiso, Chile, 2520598
      • Oncocentro Apys
• Czechia
  • Ostrava, Czechia, 70852
    • University Hospital Ostrava
  • Brno Mesto
    • Brno, Brno Mesto, Czechia, 65653
      • Masaryk Memorial Cancer Institute
  • North Central Czech Republic
    • Hradec Kralove, North Central Czech Republic, Czechia, 50005
      • University Hospital Hradec Kralove
• France
  • Avignon, France, 84918
    • Sainte Catherine Institut du Cancer Avignon Provence
  • Boulogne Billancourt, France, 92100
    • N_Hôpital Ambroise-Paré
  • Clermont Ferrand, France, 63003
    • CHU Estaing
  • Nice, France, 06202
    • Centre Hospitalier Universitaire De Nice Hopital De L Archet
  • Valence, France, 26000
    • Centre Hospitalier de Valence
  • Villejuif, France, 94805
    • Institut Gustave Roussy
  • Bourgogne
    • Dijon, Bourgogne, France, 21000
      • Centre Georges François Leclerc
  • Burgundy
    • Dijon, Burgundy, France, 21000
      • CHU-Dijon
  • Doubs
    • Besancon, Doubs, France, 25000
      • Besancon Regional University Hospital Center
  • Gironde
    • Bordeaux, Gironde, France, 33075
      • CHU de Bordeaux
  • Haute-Garonne
    • Toulouse, Haute-Garonne, France, 31059
      • Institut Claudius Regaud, IUCT-Oncopole
  • Hauts-de-France
    • Lille, Hauts-de-France, France, 59000
      • CHU de Lille
  • Herault
    • Montpellier Cedex 5, Herault, France, 34295
      • Service de Dermatologie CHU Saint Eloi
  • Ile De France
    • Bobigny, Ile De France, France, 93000
      • Hopital Avicenne
    • Creteil, Ile De France, France, 94000
      • Hospital Henri Mondor
    • Paris, Ile De France, France, 75010
      • Saint Louis Hospital
  • Isere
    • La Tronche, Isere, France, 38700
      • Centre Hospitalier Universitaire Grenoble Alpes
  • Normandy
    • Caen, Normandy, France, 14076
      • Centre Francois Baclesse (CFB)
  • Pays De La Loire
    • Le Mans, Pays De La Loire, France, 72037
      • Centre Hospitalier Le Mans
    • Nantes, Pays De La Loire, France, 44093
      • Nantes University Hospital
  • Picardie
    • Amiens, Picardie, France, 80000
      • CHU AMIENS-PICARDIE
• Georgia
  • Batumi, Georgia, 6000
    • Cancer Center of Adjara
  • Tbilisi, Georgia, 0159
    • JSC K. Eristavi National Center of Experimental and Clinical Surgery
  • Tbilisi, Georgia, 0114
    • LTD New Hospitals
  • Tbilisi, Georgia, 0112
    • Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine
  • Tbilisi, Georgia, 0112
    • Israeli Georgian Medical Research Clinic Helsicore
  • Tbilisi, Georgia, 0160
    • TIM - Tbilisi Institute of Medicine
  • Caucasus
    • Tbilisi, Caucasus, Georgia, 0144
      • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
• Germany
  • Berlin, Germany, 10117
    • Charité Universitaetsmedizin Berlin
  • Bremen, Germany, 28325
    • Klinikum Bremen Ost
  • Baden Wurttemberg
    • Mannheim, Baden Wurttemberg, Germany, 68167
      • University Medical Center Mannheim
    • Tuebingen, Baden Wurttemberg, Germany, 72076
      • University of Tuebingen
  • Bavaria
    • Augsburg, Bavaria, Germany, 86179
      • University Hospital Augsburg
    • Erlangen, Bavaria, Germany, 91054
      • Dermatology Erlangen
    • Regensburg, Bavaria, Germany, 93053
      • University Hospital of Regensburg
  • Bayern
    • Munich, Bayern, Germany, 80337
      • LMU Klinikum
  • Hessen
    • Darmstadt, Hessen, Germany, 64283
      • Klinikum Darmstadt GmbH
    • Frankfurt, Hessen, Germany, 60590
      • University Clinic Frankfurt
  • Lower Saxony
    • Gottingen, Lower Saxony, Germany, 37075
      • University Medical Center Goettingen
  • Mecklenburg / Vorpommern
    • Schwerin, Mecklenburg / Vorpommern, Germany, 19055
      • Helios Kliniken Schwerin
  • North Rhine Westphalia
    • Munster, North Rhine Westphalia, Germany, 48149
      • University hospital Muenster
  • North Rhine-Westphalia
    • Essen, North Rhine-Westphalia, Germany, 45147
      • Universitätsklinikum Essen
    • Muenster, North Rhine-Westphalia, Germany, 48157
      • Fachklinik Hornheide
  • Northrhine Westphalia
    • Bochum, Northrhine Westphalia, Germany, 44791
      • Ruhr University Bochum
  • Rheinland-Pfalz
    • Ludwigshafen, Rheinland-Pfalz, Germany, D-67063
      • Hautklinik
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • University Hospital Dresden
  • Saxony-Anhalt
    • Quedlinburg, Saxony-Anhalt, Germany, 06484
      • Skin Cancer Center Harz
  • Schleswig Holstein
    • Kiel, Schleswig Holstein, Germany, 24105
      • University Hospital of Universitatsklinikum Schleswig Holstein (UKSH) Campus Kiel
    • Luebeck, Schleswig Holstein, Germany, 23538
      • Universitatsklinikum Schleswig Holstein Campus Luebeck
  • Thuringia
    • Erfurt, Thuringia, Germany, D-99089
      • Helios Klinikum Erfurt
• Greece
  • Thessaloniki, Greece, 54622
    • Bioclinic Thessaloniki
  • Thessaloniki, Greece, 57001
    • Interbalkan Medical Center
  • Thessaloniki, Greece, 54007
    • Ongology Theageneio Thessaloniki
  • Attica
    • Athens, Attica, Greece, 11527
      • National and Kapodistrian University of Athens
    • Neo Faliro, Attica, Greece, 18547
      • Metropolitan Hospital
• Ireland
  • Cork, Ireland, T12 EC8P
    • Cork University Hospital
  • Dublin, Ireland, D09 V2N0
    • Beaumont Hospital
  • Dublin, Ireland, DO4YN63
    • St Vincents University Hospital
  • Connacht
    • Galway, Connacht, Ireland, H91 YR71
      • Galway University Hospital
• Israel
  • Jerusalem, Israel, 91120
    • Hadassah Medical Organization
  • Tel Hashomer, Israel, 5265601
    • Sheba Medical Center
  • Northern District
    • Afula, Northern District, Israel, 18340000
      • Haemek Medical Center
• Italy
  • Bari, Italy, 70124
    • Istituto dei Tumori
  • Cuneo, Italy, 12100
    • Azienda Ospedaliera Santa Croce i Carle
  • Milano, Italy, 20141
    • Istituto Europeo di Oncologia
  • Naples, Italy, 80131
    • Instituto Nazionale Tumori Fondazione Giovanni Pascale
  • Perugia, Italy, 06132
    • University Of Perugia
  • Rome, Italy, 000168
    • Fondazione Policlinico Universitrio a. Gemelli - IRCCS
  • Rome, Italy, 00128
    • Campus Bio-Medico di Roma
  • Rome, Italy, 00167
    • Istituto Dermopatico dell'Immacolata
  • Trento, Italy, 38122
    • Santa Chiara Hospital
  • Udine, Italy, 33100
    • Azienda Sanitaria Universitaria del Friuli Centrale
  • An
    • Ancona, An, Italy, 60020
      • Clinica Oncologica, AOU Riuniti ancona
  • Campania
    • Naples, Campania, Italy, 80121
      • U.O.C. Oncologia Medica ed Ematologia (U.O.C Medical Oncology and Hematology)
  • Forli Cesena
    • Meldola, Forli Cesena, Italy, 47014
      • Istituto Romagnolo per lo Studio dei Tumori (IRST)
  • Lombardy
    • Milan, Lombardy, Italy, 20089
      • Istituto Clinico Humanitas
• Mexico
  • Veracruz, Mexico, 91910
    • Faicic Centro de Investigacion Clinica de Veracruz
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37178
      • Preparaciones Oncologica SC
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
    • Guadalajara, Jalisco, Mexico, 44670
      • Pan American Clinical Research
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64710
      • iCan Oncology
  • Sinaloa
    • Culiacan, Sinaloa, Mexico, 80020
      • Neurociencias Estudios Clínicos SC
  • Yucatan
    • Merida, Yucatan, Mexico, 97134
      • Centro De Atencion E Investigacion Clinica En Oncologia SCP
• Poland
  • Mazxowieckie
    • Siedlce, Mazxowieckie, Poland, 08-110
      • Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii
  • Pomerania
    • Gdansk, Pomerania, Poland, 80-214
      • UCK
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80-219
      • Copernicus Podmiot Leczniczy Sp. z o.o.Wojewodzie Centrum Onkologii
    • Slupsk, Pomorskie, Poland, 76-200
      • Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.
  • Wielkopolska
    • Poznan, Wielkopolska, Poland, 60-788
      • Poznan University of Meidcla Science
• Romania
  • Iasi, Romania, 700106
    • Centrul de Oncologie Euroclinic
  • Bucuresti
    • Bucharest, Bucuresti, Romania, 022328
      • Institute of Oncology Bucharest
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400015
      • Cardiomed
    • Cluj-Napoca, Cluj, Romania, 400015
      • Institute of Oncology Prof. Dr Ion Chirircuta
  • Cluj County
    • Floresti, Cluj County, Romania, 407280
      • Radiotherapy Center Cluj
  • Dolj
    • Craiova, Dolj, Romania, 200347
      • Sfantul Nectarie Oncology Center
  • Timis
    • Timisoara, Timis, Romania, 300239
      • OncoMed
    • Timisoara, Timis, Romania, 300166
      • Oncocenter Oncologie Clinica S.R.L
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2196
      • The Medical Oncology Centre of Rosebank
    • Pretoria, Gauteng, South Africa, 0081
      • Wilgers Oncology Centre
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7925
      • Groote Schuur Hospital
    • Kraaifontein, Western Cape, South Africa, 7570
      • Cape Town Oncology Trials
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Hospital Vall D'Hebron
  • Barcelona, Spain, 08908
    • Catalan Institute of Oncology (ICO) Hospitalet
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augusti
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM
  • Madrid, Spain, 28046
    • Hospital Universitario La Pa<
  • Madrid, Spain, 28050
    • Centro Integral Oncologico HM Clara Campal
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Valencia, Spain, 46009
    • Instituto Valenciano de Oncologia
  • Valencia, Spain, 46010
    • Incliva - Instituto de Investigacion Sanitaria
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • H. Germans Trias i Pujol, ICO-Badalona
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla
  • Catalunya
    • Barcelona, Catalunya, Spain, 08028
      • Instituto Oncologico Dr Rosell Hospital Universitari Quiron Dexeus Location
• Turkey
  • Ankara, Turkey, 06010
    • Gülhane Research and Training Hospital
  • Ankara, Turkey, 06100
    • Ozel Liv Hospital
  • Ankara, Turkey, 06100
    • Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam
  • Ankara, Turkey, 0906520
    • Memorial Ankara Hospital
  • Edirne, Turkey, 22030
    • Trakya University
  • Istanbul, Turkey, 34450
    • Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty
  • Istanbul, Turkey, 81450
    • Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital
  • Adana
    • Yuregir, Adana, Turkey, 01230
      • Baskent University
  • Diyarbakir
    • Sur, Diyarbakir, Turkey, 21200
      • Dicle University - Medical Faculty Campus
  • Kocaeli
    • İzmit, Kocaeli, Turkey, 41380
      • Kocaeli University
  • Sehitkamil
    • Gaziantep, Sehitkamil, Turkey, 27584
      • Gaziantep Medicalpoint Hospital
• United Kingdom
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals
  • London, United Kingdom, EC1A 7BE
    • Saint Bartholomew's Hospital
  • Manchester, United Kingdom, M20 4BX
    • The Christie
  • Taunton, United Kingdom, TA1 5DA
    • Taunton and Somerset NHS Foundation Trust
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Royal Devon and Exeter Hospital NHS Trust
  • Lothian
    • Edinburgh, Lothian, United Kingdom, EH4 2XU
      • Edinburgh Cancer Centre
  • Somerset
    • Bristol, Somerset, United Kingdom, BS2 8ED
      • Bristol Haematology And Oncology Centre (BHOC) - Bristol Cancer Institute
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • The Royal Marsden NHS Foundation Trust
  • West Midlands
    • Coventry, West Midlands, United Kingdom, CV2 2DX
      • University Hospital Coventry and Warwickshire NHS Trust
• United States
  • California
    • La Jolla, California, United States, 92093
      • UC San Diego
    • San Francisco, California, United States, 94158
      • UCSF Medical Center at Mission Bay
    • Santa Monica, California, United States, 90404
      • John Wayne Cancer Institute (JWCI)
  • Colorado
    • Englewood, Colorado, United States, 80113
      • The Melanoma and Skin Cancer Institute
  • Florida
    • Miami, Florida, United States, 33176
      • Miami Cancer Institute at Baptist Health, Inc.
    • Orlando, Florida, United States, 32806
      • Orlando Health
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Cancer Institute of New Jersey
  • New York
    • New York, New York, United States, 10032
      • Columbia University
    • New York, New York, United States, 10016
      • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
    • Rochester, New York, United States, 14642
      • University of Rochester
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Lineberger Comprehensive Cancer Center
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Institute, University Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Columbus, Ohio, United States, 43210
      • The Ohio State University James Comprehensive Cancer Center
  • Pennsylvania
    • Easton, Pennsylvania, United States, 18045
      • St Lukes University Health Network
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center
    • Nashville, Tennessee, United States, 37203-1625
      • Tennessee Oncology - Centennial Clinic Location
    • Nashville, Tennessee, United States, 37203
      • Verdi Oncology
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fianlimab HD + Cemiplimab; Patients will be administered one combination dose of fianlimab high dose (HD) and cemiplimab	Drug: Fianlimab; Fianlimab will be administered by intravenous (IV) infusion every (Q) 3 weeks; Other Names: REGN3767; Drug: Cemiplimab; Cemiplimab will be administered by IV infusion Q 3 weeks; Other Names: REGN2810; Libtayo
Experimental: Fianlimab LD + Cemiplimab; Patients will be administered one combination dose of fianlimab low dose (LD) and cemiplimab	Drug: Fianlimab; Fianlimab will be administered by intravenous (IV) infusion every (Q) 3 weeks; Other Names: REGN3767; Drug: Cemiplimab; Cemiplimab will be administered by IV infusion Q 3 weeks; Other Names: REGN2810; Libtayo
Active Comparator: Pembrolizumab; Patients will be administered one dose of pembrolizumab co-infused with saline/dextrose placebo	Drug: Pembrolizumab; Pembrolizumab will be administered by IV infusion Q 3 weeks; Other Names: Keytruda; lambrolizumab; MK-3475; Drug: Placebo; Matching placebo co-infused with pembrolizumab IV, will be administered by IV infusion Q 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Time from randomization to the date of death.	Up to 5 Years
Distant metastasis-free survival (DMFS)	Time between the date of randomization and the date of the first distant metastasis.	Up to 5 Years
Occurrence of treatment-emergent adverse events (TEAEs)	A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.	Up to 5 Years
Occurrence of immune-mediated EAEs (im-EAEs)	imAEs are a unique set of toxicities thought to be caused by unrestrained cellular immune responses.	Up to 5 Years
Occurrence of serious adverse events (SAEs)	An SAE is any untoward medical occurrence that at any dose: Results in death - includes all deaths, even those that appear to be completely unrelated to study drug (eg, a car accident in which a patient is a passenger).; Is life-threatening; Requires in-patient hospitalization or prolongation of existing hospitalization.; Results in persistent or significant disability/incapacity; Is a congenital anomaly/birth defect.; Is an important medical event	Up to 5 Years
Occurrence of adverse events of special interest (AESIs)	An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the sponsor can be appropriate. Such an event might warrant further investigation in order to characterize and understand it	Up to 5 Years
Occurrence of TEAEs resulting in death	A TEAE resulting in death is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.	Up to 5 Years
Occurrence of dose-limiting toxicity (DLT)	A DLT is defined as a study-drug related TEAE, including imAEs, that could preclude enrolling additional adolescent patients at the selected dose. Dose-limiting toxicity will be evaluated in adolescents only.	Up to 5 Years
Occurrence of interruption or discontinuation of study drug(s) due to TEAE	A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.	Up to 5 Years
Occurrence of laboratory abnormalities	As assessed by the NCI-CTCAE grading system (≥ Grade 3 or higher)	Up to 5 Years
Concentrations of fianlimab in serum over time	The concentrations of fianlimab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients.	Up to 5 Years
Concentrations of cemiplimab in serum over time	The concentrations of cemiplimab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients.	Up to 5 Years
Concentration of finalimab anti-drug antibodies (ADA) and neutralizing antibodies	Immunogenicity will be characterized per drug molecule by ADA and NAb status.	Up to 5 Years
Concentration of cemiplimab anti-drug antibodies (ADA) and neutralizing antibodies	Immunogenicity will be characterized per drug molecule by ADA and NAb status.	Up to 5 Years
Patient report outcomes (PRO) for adults as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)	The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. More points are considered to have a better outcome.	Up to 5 Year
PRO for adults as measured by the European Quality of Life Dimension 5 (EQ-5D-5L)	The EQ-5D-5L a descriptive system that 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. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	Up to 5 Years
PRO for adults as measured by the Functional Assessment of Cancer Therapy (FACT) - melanoma	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).	Up to 5 Years
PRO for adults as determined by the Patient Global Impressions Scale (PGIS)	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".	Up to 5 Years
PRO for adults as determined by the Patient Global Impressions of Change Scale (PGIC)	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".	Up to 5 Years
Time to global health status/quality of life deterioration per EORTC QLQ-C30		Up to 5 years
Time to physical functioning deterioration per EORTC QLQ-C30		Up to 5 Years
Time to role functioning deterioration per EORTC QLQ-C30		Up to 5 Years

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Publications and helpful links

Helpful Links

• A clinical study for adults and adolescents who are melanoma-free following surgery.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2023
• Primary Completion (Estimated): May 16, 2028
• Study Completion (Estimated): February 15, 2030

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 31, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Skin Cancer; Stage III; Resected High Risk Melanoma; Stage IIC; Stage IV; LAG-3 Lymphocyte activation gene 3; Adjuvant Setting; anti-PD-1 Monoclonal Antibody; Stage IIB
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Melanoma; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Cemiplimab; Pembrolizumab
• Other Study ID Numbers: R3767-ONC-2055; 2022-501576-25-00 (Registry Identifier: EUCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD Sharing 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.

• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No