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: Recruiting
• Conditions: Melanoma
• Intervention / Treatment: Drug: Fianlimab; Drug: Cemiplimab; Drug: Pembrolizumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 1530
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Trials Administrator; Phone Number: 844-734-6643; Email: clinicaltrials@regeneron.com

Study Locations

• Argentina
  • Buenos Aires
    • Ciudad Autonoma, Buenos Aires, Argentina
      • Recruiting
      • DIABAID - Instituto de Asistencia Integral en Diabetes
    • Ciudad Autonoma, Buenos Aires, Argentina, C1125ABD
      • Recruiting
      • Fundación CENIT para la Investigación en Neurociencias
  • Rio Negro
    • Viedma, Rio Negro, Argentina, 8500
      • Recruiting
      • Clinica Viedma S.A.
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000KZE
      • Recruiting
      • Instituto de Oncologia de Rosario - Departamento de Investigaciones
  • Tacuman Province
    • San Miguel de Tucumán, Tacuman Province, Argentina, 4000
      • Recruiting
      • Centro Medico San Roque
• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Recruiting
      • Liverpool Hospital (Cancer Therapy Pharmacy)
  • South Australia
    • Adelaide, South Australia, Australia, 5006
      • Recruiting
      • Calvary North Adelaid Hospital (HPS Pharmacies)
    • Bedford Park, South Australia, Australia, 5042
      • Recruiting
      • Flinders Medical Centre
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Recruiting
      • Box Hill Hospital
    • Geelong, Victoria, Australia, 3220
      • Recruiting
      • Andrew Love Cancer Centre, University Hospital Geelong
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • Alfred Health
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Recruiting
      • One Clinical Research
• Belgium
  • East Flanders
    • Sint Niklaas, East Flanders, Belgium, 9100
      • Recruiting
      • VITAZ vzw - pharm Sara Van Opdenbosch t.a.v. apotheek
  • Region De Bruxelles
    • Brussels, Region De Bruxelles, Belgium, 1200
      • Recruiting
      • Cliniques Universitaires Saint-Luc
  • West-Vlaaderen
    • Kortrijk, West-Vlaaderen, Belgium, 8500
      • Recruiting
      • Campus Kennedylaan Apotheek
• Brazil
  • Sao Paulo, Brazil, 01308-050
    • Recruiting
    • Hospital Sirio-Libanes
  • Sao Paulo, Brazil, 14784-400
    • Recruiting
    • Nucleo de Pesquisa da Rede Sao Camilo (Instituto Brasileiro de Controle do Cancer)
  • Minas Geraise
    • Belo Horizonte, Minas Geraise, Brazil, 30130-090
      • Recruiting
      • Centro Avancado de Tratamento Oncologico (CENANTRON)
  • Parana
    • Curitiba, Parana, Brazil, 81520-060
      • Recruiting
      • Hospital Erasto Gaertner
  • Rio De Janeiro
    • Santo Cristo, Rio De Janeiro, Brazil, 20220-410
      • Recruiting
      • INCA - Brazilian National Cancer Institute
  • Rio Grande Do Sul
    • Ijui, Rio Grande Do Sul, Brazil, 98700-000
      • Recruiting
      • ONCOSITE - CENTRO DE PESQUISA CLINICA EM ONCOLOGIA LTDA Setor Farmacia Pesquisa Clini
    • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
      • Recruiting
      • Hospital Sao Vicente de Paulo - Instituto do Cancer
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-001
      • Recruiting
      • Associacao Hospitalar Moinhos de Vento, Centro de Pesquisa Clinica
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • Recruiting
      • CPO - Centro de Pesquisas em Oncologia
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Recruiting
      • Hospital de Clinicas de Porto Alegre - UPCO- pesquisa Clinica em Oncologia do HCPA
  • Santa Catarina
    • Itajai, Santa Catarina, Brazil, 88301-220
      • Recruiting
      • Clinica de Neoplasias Litoral
    • Joinville, Santa Catarina, Brazil, 89201-260
      • Recruiting
      • Instituto Joinvilense de Hematologia e Oncologia
    • Lages, Santa Catarina, Brazil, 88501-001
      • Recruiting
      • Animi Unidade de Tratamento Oncologico Ltda
  • Sao Paulo
    • Barretos, Sao Paulo, Brazil, 14784-400
      • Recruiting
      • Fundacao Pio XII - Hospital de Cancer de Barretos
  • Sao Paulo Estado
    • Sao Paulo, Sao Paulo Estado, Brazil, 01236-030
      • Recruiting
      • Instituto de Ensino e Pesquisas Sao Lucas - IEP HEMOMED
• Canada
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B5N5
      • Recruiting
      • Dr. Everett Chalmers Hospital
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Recruiting
      • Royal Victoria Regional Health Centre
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Research Institute
    • Toronto, Ontario, Canada, M5G 2C1
      • Recruiting
      • University Health Network, Princess Margaret Cancer Centre
• Chile
  • Valparaiso, Chile, 2520598
    • Recruiting
    • Oncocentro APYS
  • Metropolitana De Santiago
    • Santiago, Metropolitana De Santiago, Chile, 7560907
      • Recruiting
      • Universidad Mayor - Centro Oncologia de Precision (PROFAR)
    • Santiago, Metropolitana De Santiago, Chile, 7620002
      • Recruiting
      • Clinica UC San Carlos de Apoquindo
  • Santiago Region Metropolitana De Santiago
    • Santiago, Santiago Region Metropolitana De Santiago, Chile, 7510032
      • Recruiting
      • Oncovida
• Czechia
  • Bohemia
    • Hradec Kralove, Bohemia, Czechia, 50005
      • Recruiting
      • University Hospital Hradec Kralove
  • Moravia Region
    • Ostrava, Moravia Region, Czechia, 70852
      • Recruiting
      • University Hospital Ostrava Pharmacy
  • South Moravian
    • Brno, South Moravian, Czechia, 65653
      • Recruiting
      • Masaryk Memorial Cancer Institute, Hospital Pharmacy
• France
  • Nice, France, 06200
    • Recruiting
    • Centre Hospitalier Universitaire de Nice,Hopital l Archet
  • Rouen, France, 76031
    • Recruiting
    • CHU Charles Nicolle
  • Bourgogne
    • Besancon Cedex, Bourgogne, France, 25030
      • Recruiting
      • CHU Jean Minjoz
  • Bourgogne-Franche-Comte
    • Dijon, Bourgogne-Franche-Comte, France, 21000
      • Recruiting
      • CHU de DIJON - Pharmacie Essais Cliniques
  • Bourgogne-Franche-Comté
    • Dijon, Bourgogne-Franche-Comté, France, 21079
      • Recruiting
      • Centre Georges Francois Leclerc
  • Grenoble
    • La Tronche, Grenoble, France, 38700
      • Recruiting
      • CHU Grenoble Alpes
  • Haute-Garonne
    • Toulouse, Haute-Garonne, France, 31059
      • Recruiting
      • Institut Claudius Regaud - Pharmacie
  • Ile De France
    • Vaillant, Ile De France, France, 94805
      • Recruiting
      • Gustave Roussy - Pharmacie Essais Cliniques -1
  • Ile-de-France
    • Paris, Ile-de-France, France, 75010
      • Recruiting
      • Hopital Saint Louis - APHP, Service de Pharmacie - Niveau
  • Nord Deparment
    • Lille, Nord Deparment, France, 59037
      • Recruiting
      • CHU Lille, Pharmacie Centrale
  • Normandy
    • Caen, Normandy, France, 14076
      • Recruiting
      • Centre Francois Baclesse
  • Nouvelle-Aquitaine
    • Bordeaux, Nouvelle-Aquitaine, France, 33075
      • Recruiting
      • Hopital Saint Andre, Pharmacie
  • Occitanie Region
    • Montpellier, Occitanie Region, France, 34090
      • Recruiting
      • Unite de Pharmacie Clinique Oncologique (UPCO)
  • Paris
    • Boulogne Billancourt, Paris, France, 92100
      • Recruiting
      • Hopital Ambroise Pare
    • Creteil, Paris, France, 94000
      • Recruiting
      • CHU HENRI MONDOR Pharmacie Secteur ESSAIS CLINIQUES
  • Pays De La Loire Région
    • Nantes, Pays De La Loire Région, France, 44000
      • Recruiting
      • CHU de Nantes hotel Dieu
  • Province Alpes Cote d'Azur
    • Avignon, Province Alpes Cote d'Azur, France, 84918
      • Recruiting
      • Sainte Catherine Institut du Cancer Avignon Provence
  • Puy-de-Dôme
    • Clermont-Ferrand, Puy-de-Dôme, France, 63003
      • Recruiting
      • CHU G. Montpied, Pharmacie, secteur recherche clinique
  • Sarthe
    • Le Mans, Sarthe, France, 72037
      • Recruiting
      • CH Le Mans - CCS Pharmacie-essais cliniques, aile B
  • Seine Saint Denis
    • Bobigny, Seine Saint Denis, France, 93000
      • Recruiting
      • Hopital Avicenne Service Pharmacie Secteur essais cliniques
  • Somme
    • Amiens, Somme, France, 80054
      • Recruiting
      • CHU Amiens-Picardie Site Sud
• Georgia
  • Adjara
    • Batumi, Adjara, Georgia, 6000
      • Recruiting
      • LTD Cancer Center of Adjara Autonomic Republic
  • South Caucasus
    • T'bilisi, South Caucasus, Georgia, 0112
      • Recruiting
      • Israeli Georgian medical research clinic Helsicore
    • T'bilisi, South Caucasus, Georgia, 0112
      • Recruiting
      • LTD Research Institute of Clinical Medicine (LLC Todua Clinic)
    • T'bilisi, South Caucasus, Georgia, 0114
      • Recruiting
      • Ltd New Hospitals
    • T'bilisi, South Caucasus, Georgia, 0144
      • Recruiting
      • High Technology Medical Center, University Clinic Tbilisi
    • T'bilisi, South Caucasus, Georgia, 0168
      • Recruiting
      • Tbilisi Institute of Medicine (TIM)
    • Tbilisi, South Caucasus, Georgia, 0159
      • Recruiting
      • JSC K. Eristavi National Center of Experimental and Clinical Surgery
• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Campus Virchow Klinikum, Apotheke Zytostatika Studien, Charite - Universitatsmedizin Berlin,
  • Bochum, Germany, 44791
    • Recruiting
    • Katholisches Klinikum Bochum -Zentral Apotheke
  • Bremen, Germany, 28325
    • Recruiting
    • Klinikum Bremen-Ost - Studienambulanz Dermatologie
  • Erfurt, Germany, 99089
    • Recruiting
    • Helios Klinikum Erfurt
  • Essen, Germany, 45147
    • Recruiting
    • Universitaetsklinikum Essen, Apotheke
  • Regensburg, Germany, 93053
    • Recruiting
    • Universitatsklinikum Regensburg Studienburo Dermatologie
  • Baden-Wurttemberg
    • Mannheim, Baden-Wurttemberg, Germany, 68167
      • Recruiting
      • University Medical Center Mannheim
    • Tubingen, Baden-Wurttemberg, Germany, 72076
      • Recruiting
      • University Hospital Tuebingen
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • Hautklinik Universitatsklinikum Erlangen
    • Munchen, Bavaria, Germany, 80337
      • Recruiting
      • LMU Klinikum Munchen, Pharmacy
  • Hessen
    • Darmstadt, Hessen, Germany, 64283
      • Recruiting
      • Klinikum Darmstadt GmbH
  • Lower Saxony
    • Gottingen, Lower Saxony, Germany, 37075
      • Recruiting
      • Universitatsmedizin Gottingen
  • Mecklenburg Vorpommern
    • Schwerin, Mecklenburg Vorpommern, Germany, 19055
      • Recruiting
      • Helios Kliniken Schwerin GmbH, Apotheke
  • North Rhine-Westphalia
    • Muenster, North Rhine-Westphalia, Germany, 48157
      • Suspended
      • Hohenzollernapotheke
    • Muenster, North Rhine-Westphalia, Germany, 48149
      • Recruiting
      • Universitaetstklinikum Muenster Central Study Coordination for innovative Dermatology (ZID)
  • Rhindeland Palatinate
    • Ludwigshafen, Rhindeland Palatinate, Germany, 67063
      • Recruiting
      • Klinikum der Stadt Ludwigshafen am Rhein
  • Sachsen-Anhalt
    • Quedlinburg, Sachsen-Anhalt, Germany, 06484
      • Recruiting
      • Harzklinikum Dorothea Christiane Erxleben GmbH, Zentrale Krankenhausapotheke
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Recruiting
      • Universitatsklinikum Carl Gustav Carus Dresden, Klinik Apotheke - building 60
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Recruiting
      • UKSH-Campus Kiel
• Greece
  • Athens
    • Goudi, Athens, Greece, 11527
      • Recruiting
      • A Oncology Dpt, Laiko General Hospital of Athens
  • Pireas
    • Athens, Pireas, Greece, 18547
      • Recruiting
      • A Oncology Dpt, Metropolitan Hospital
  • Pylaia
    • Thessaloniki, Pylaia, Greece, 54622
      • Recruiting
      • Bioclinic of Thessaloniki
    • Thessaloniki, Pylaia, Greece, 57001
      • Recruiting
      • Iatriko Diavalkaniko Thessaloniki, Pharmacy
  • Thessalonili
    • Efkarpia, Thessalonili, Greece, 56403
      • Recruiting
      • Theagenio Cancer Center
• Ireland
  • Dublin, Ireland, D04 T6F4
    • Recruiting
    • St Vincent's University Hospital
  • Connacht
    • Galway, Connacht, Ireland, H91 YR71
      • Recruiting
      • University Hospital Galway
  • Dublin
    • Beaumont, Dublin, Ireland, D09V2N0
      • Recruiting
      • Beaumont Hospital
  • Munster
    • Cork, Munster, Ireland
      • Recruiting
      • University College Cork-Cork University Maternity Hospital
• Israel
  • Jerusalem, Israel, 91120
    • Recruiting
    • Hadassah Ein Kerem Medical Center
  • Northern District
    • Afula, Northern District, Israel, 1834111
      • Recruiting
      • Haemek Medical Center
  • Tel Aviv
    • Ramat-Gan, Tel Aviv, Israel, 52621
      • Recruiting
      • The Chaim Sheba Medical Center
• Italy
  • Novara, Italy, 28100
    • Recruiting
    • Azienda Ospedaliero Universitaria Maggiore della Carita, Farmacia Ospedaliera
  • Taormina, Italy, 98039
    • Recruiting
    • UOC Oncologia Medica
  • Torrette, Italy, 60126
    • Recruiting
    • Farmacia Ospedaliera - Azienda Ospedaliero Universitaria delle Marche
  • Trento, Italy, 38123
    • Recruiting
    • Ospedale S.Chiara - APSS di Trento - Magazzino Farmacia
  • Abruzzo
    • L'Aquila, Abruzzo, Italy, 67100
      • Recruiting
      • UOC del Farmaco - PO San Salvatore
  • Campania
    • Napoli, Campania, Italy, 80131
      • Recruiting
      • Instituto Nazionale Tumori IRCCS Fondazione G. Pascale
    • Napoli, Campania, Italy, 80121
      • Recruiting
      • Universita della Campania Luigi Vanvitella
  • Friuli-Venezia Giulia
    • Udine, Friuli-Venezia Giulia, Italy, 33100
      • Recruiting
      • Clinica Malattie Infettive, Azienda Ospedaliero Universitaria
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Recruiting
      • Farmacia Ospedaliera, Fondazione Policlinico Universitario Agostini Gemeli IRCCS
    • Rome, Lazio, Italy, 00128
      • Recruiting
      • Fondazione Policlinico Campus Bio-Medico
  • Lombardy
    • Milan, Lombardy, Italy, 20141
      • Recruiting
      • Farmacia Ospedaliera, Instituto Europeo di Oncologia
  • Metropolitan City Of Bari
    • Bari, Metropolitan City Of Bari, Italy, 70124
      • Recruiting
      • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Tumori Giovanni Paolo II - Ospedale Oncologico di Bari
  • Piedmont
    • Cuneo, Piedmont, Italy, 12100
      • Recruiting
      • AO S.Croce E Carle
  • Rome Province
    • Roma, Rome Province, Italy, 00167
      • Recruiting
      • Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss)
  • Umbria
    • Perugia, Umbria, Italy, 06132
      • Recruiting
      • AO perugia SC Oncologia
  • Veneto
    • Cona, Veneto, Italy, 44124
      • Recruiting
      • Arcispedale SantAnna UOC Farmacia Ospedaliera Ufficio sperimentazioni cliniche, SETTORE 2B1 Presidi
• Mexico
  • Guanajuato
    • Leon Guanajuato, Guanajuato, Mexico, 37178
      • Recruiting
      • Preparaciones Oncologicas S. C.
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Recruiting
      • Hospital Civil de Guadalajara Fray Antonio Alcalde
    • Zapopan, Jalisco, Mexico, 45070
      • Recruiting
      • Investigacion Biomedica para el Desarrollo de Farmacos S.A de C.V
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64710
      • Recruiting
      • iCan Oncology Center S.A de C.V.
  • Sinaloa
    • Culiacan, Sinaloa, Mexico, 80020
      • Recruiting
      • Neurociencias Estudios Clinicos S. C.
  • Veracruz Estado
    • Veracruz, Veracruz Estado, Mexico, 91900
      • Recruiting
      • FAICIC S. de R.L. de C.V.
  • Yucatan
    • Merida, Yucatan, Mexico, 97134
      • Recruiting
      • Centro de Atención e Investigación Clínica en Oncología
• Poland
  • Mazowieckie
    • Siedlce, Mazowieckie, Poland, 08-110
      • Recruiting
      • Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii
  • Pomeria
    • Gdansk, Pomeria, Poland, 80-214
      • Recruiting
      • Uniwersyteckie Centrum Kliniczne (UCK)
  • Pomorskie
    • Slupsk, Pomorskie, Poland, 16-200
      • Recruiting
      • Wojewodzki Szpital Specjalistyczny im. J. Korczaka w Slupsku
• Romania
  • Bucharest, Romania, 022328
    • Recruiting
    • Institute of Oncology Bucharest
  • Dolj
    • Craiova, Dolj, Romania, 200542
      • Recruiting
      • Centrul de Oncologie Sf. Nectarie S.R.L/SC
  • Floresti
    • Cluj, Floresti, Romania, 407280
      • Recruiting
      • Radiotheraoy Center Cluj/Ph
  • Moldava
    • Iași, Moldava, Romania, 700106
      • Recruiting
      • Centrul de Oncologie Euroclinic
  • Timis
    • Timisoara, Timis, Romania, 300210
      • Recruiting
      • Oncocenter-Oncologie Clinica SRL
    • Timisoara, Timis, Romania, 300239
      • Recruiting
      • Oncomed
  • Transylvania
    • Cluj Napoca, Transylvania, Romania, 400015
      • Recruiting
      • Cardiomed
    • Cluj Napoca, Transylvania, Romania, 400015
      • Recruiting
      • Institul Oncologic Prof. Dr Ion Chiricuta
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2196
      • Recruiting
      • The Medical Oncology Centre of Rosebank
    • Pretoria, Gauteng, South Africa, 7570
      • Recruiting
      • Wilgers Oncology Center
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7570
      • Recruiting
      • Cape Gate Oncology Trials
• Spain
  • Badalona, Spain, 08916
    • Recruiting
    • Institut Catala d'Oncologia
  • Granada, Spain, 18014
    • Recruiting
    • Hospital Universitario Virgen de las Nieves
  • Lugo, Spain, 27003
    • Recruiting
    • Hospital Universitario Lucus Augusti
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital 12 de Octubre
  • Madrid, Spain, 28050
    • Recruiting
    • Hospital Universitario HM Sanchinarro
  • Madrid, Spain, 28007
    • Recruiting
    • Hospital General Universitario Gregorio Marañon (HGUGM)
  • Valencia, Spain, 46010
    • Recruiting
    • Hospital Clínico Universitario de Valencia
  • Valencia, Spain, 46009
    • Recruiting
    • Fundacion Instituto Valenciano de Oncologia
  • Andalucia
    • Sevilla, Andalucia, Spain, 41009
      • Recruiting
      • Hospital Universitario Virgen Macarena
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Recruiting
      • Hospital Universitario Central de Asturias
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • Hospital Universitario Marqués de Valdecilla
  • Catalonia
    • Barcelona, Catalonia, Spain, 08028
      • Recruiting
      • Hospital Universitario Quiron Dexeus Barcelona
    • Barcelona, Catalonia, Spain, 08035
      • Recruiting
      • Area dassajos clinics/Medicaments en investigacio, Servei de Farmacia Hospital Clinic de Barcelona (ICMHO)
    • Barcelona, Catalonia, Spain, 08035
      • Recruiting
      • Hospital Universitario Vall d'Hebron, Edificio General-Planta Baja, UITM, Unidad de Farmacia de Ensa
  • Madrid Provincia
    • Madrid, Madrid Provincia, Spain, 28046
      • Recruiting
      • Hospital Universitario La Paz
• Turkey
  • Anatolia
    • Ankara, Anatolia, Turkey, 06100
      • Recruiting
      • Sbu Dr. A.Y. Ankara Onkoloji Suam
  • Ankara
    • Keçiören, Ankara, Turkey, 06010
      • Recruiting
      • Gulhane Egitim ve Arastirma Hastanesi
  • Central Anatolia
    • Ankara, Central Anatolia, Turkey, 06010
      • Recruiting
      • Liv Hospital
    • Ankara, Central Anatolia, Turkey, 06520
      • Recruiting
      • Ankara Memorial Hospital
  • Cilicia
    • Adana, Cilicia, Turkey, 01120
      • Recruiting
      • Adana Kisla Baskent Unv Hospital
  • Diyarbakir Province
    • Diyarbakir, Diyarbakir Province, Turkey, 21280
      • Recruiting
      • Dicle University, Faculty of Medicine
  • Edime
    • Iskender, Edime, Turkey, 22130
      • Recruiting
      • Trakya Universitesi, Balkan Onkoloji Hastanesi Linik Arastirmar Odasi
  • Gaziantep
    • Sehitkamil, Gaziantep, Turkey, 27310
      • Recruiting
      • Medical Park Gaziantep Hastanesi
  • Istanbul
    • Fatih, Istanbul, Turkey, 34098
      • Recruiting
      • Istanbul Universitesi CerrahpaSa- Cerrahpasa Tip Fakultesi
  • Istanbul Province
    • Istanbul, Istanbul Province, Turkey, 81450
      • Recruiting
      • Goztepe Prof. Dr. Suleyman Yalcin City Hospital
  • Izmir Province
    • Izmir, Izmir Province, Turkey, 35360
      • Recruiting
      • Izmir Katip Celebi University Ataturk training and Research Hospital
  • Kocaeli
    • Umuttepe, Kocaeli, Turkey, 41380
      • Recruiting
      • Kocaeli University Hospital
• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • Recruiting
    • Pharmacy Chemotherapy Unit, St Barthomews Hospital West Smithfield
  • Manchester, United Kingdom, M20 4BX
    • Recruiting
    • The Christie Nhs Foundation Trust
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Recruiting
      • Royal Devon University Healthcare NHS Foundation Trust, Clinical Trials Pharmacy
  • London
    • Chelsea, London, United Kingdom, SW3 6JJ
      • Recruiting
      • Clinical research pharmacy
  • Lothian
    • Edinburgh, Lothian, United Kingdom, EH4 2LF
      • Recruiting
      • Pharmacy Clinical Trials, Pharmacy Department, Alexander Donald Building, Western General Hospital
  • Somerset
    • Bristol, Somerset, United Kingdom, BS2 8ED
      • Recruiting
      • Clinical Trials Unit Bristol Haematology & Oncology Centre
    • Taunton, Somerset, United Kingdom, TA1 5DA
      • Recruiting
      • Musgrove Park Hospital, Somerset Foundation Trust
• United States
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • University of California San Diego
    • San Francisco, California, United States, 94158-3214
      • Recruiting
      • University of California, San Francisco
    • Santa Monica, California, United States, 90404-2312
      • Recruiting
      • John Wayne Cancer Institute - Saint John's Health Center
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Recruiting
      • The Melanoma and Skin Cancer Institute
  • Florida
    • Miami, Florida, United States, 33176
      • Recruiting
      • Miami Cancer Institute
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Orlando Health Cancer Institute
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Medical Group
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Cancer Center
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Rutgers Cancer Institute of New Jersey
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • Lineberger Comprehensive Cancer Center
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Foundation
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
  • Pennsylvania
    • Easton, Pennsylvania, United States, 18045
      • Recruiting
      • St. Luke's Hematology
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University Hospital
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Recruiting
      • University of Tennessee Medical Center
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Tennessee Oncology
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • SCRI Partners - Verdi Oncology
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • The University of Texas Southwestern Medical Center
  • Utah
    • Murray, Utah, United States, 84107
      • Recruiting
      • Intermountain Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia Health System
    • Fairfax, Virginia, United States, 22031
      • Withdrawn
      • Virginia Cancer Specialist Research Institute

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): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

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: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Melanoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Pembrolizumab; Cemiplimab
• 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, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has 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