Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

April 21, 2026 updated by: Regeneron Pharmaceuticals

A Phase 3 Trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called REGN2810, also known as cemiplimab (each individually called a "study drug" or called "study drugs" when combined).

The study is focused on patients with a type of skin cancer known as melanoma. The aims of the study are to see how effective the combination of fianlimab and cemiplimab are in treating the melanoma skin cancer, in comparison with a medication, pembrolizumab, approved for the treatment of melanoma skin cancer in adults, and to observe any similarities, or differences, in how the study drugs work in adolescent participants compared with adult participants.

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 drugs (which could make the drugs 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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1546

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1125
        • Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion)
      • San Miguel de Tucumán, Argentina, 4000
        • Exelsus
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1061
        • DIABAID - Instituto de Asistencia Integral en Diabetes
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1408
        • Centro Medico Austral
      • Pergamino, Buenos Aires, Argentina, B2700CPM
        • Centro de Investigación Pergamino
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000KZE
        • Instituto de Oncología de Rosario
  • Australia
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Gold Coast Hospital and Health Service
      • Townsville, Queensland, Australia, 4814
        • Townsville University Hospital
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
        • Calvary North Adelaide Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Icon Cancer Centre Hobart
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • Andrew Love Cancer Centre
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
  • Austria
      • Vienna, Austria, 1090
        • Medical University Vienna
    • Lower Austria
      • Sankt Pölten, Lower Austria, Austria, 3100
        • University Hospital Saint Poelten
    • Styria
      • Graz, Styria, Austria, 8036
        • Medical University of Graz
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Medical University Innsbruck
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques universitaires Saint-Luc
      • Namur, Belgium, B5000
        • Centre Hospitalier Universitaire Universite Catholique de Louvain Namur Site Sainte Elisabeth
    • West-Vlaanderen
      • Kortrijk, West-Vlaanderen, Belgium, 8500
        • AZ Groeninge
      • Sint-Niklaas, West-Vlaanderen, Belgium, 9100
        • AZ Nikolaas
  • Brazil
      • Ijuí, Brazil, 98700-000
        • Oncosite Centro De Pesquisa Em Oncologia
      • Rio de Janeiro, Brazil, 23793-080
        • Instituto Coi
      • Rio de Janeiro, Brazil, 20220-280
        • INCA - Brazilian National Cancer Institute
      • São Paulo, Brazil, 01308-050
        • Hospital Sirio Libanes
      • São Paulo, Brazil, 04014-002
        • Sao Camilo Oncologia
      • São Paulo, Brazil, 01236030
        • Hemomed
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 41253900
        • Hospital Sao Rafael
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-090
        • Hospital das Clinicas da Universidade Federal de Minas Gerais
    • Paraná
      • Curitiba, Paraná, Brazil, 81520-060
        • Liga Paranaense de Combate ao Câncer - Hospital Erasto Gaertner
    • Rio Grande do Sul
      • Lajeado, Rio Grande do Sul, Brazil, 95900-022
        • Hospital Bruno Born
      • 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 Clínicas 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
    • Rondônia
      • Porto Velho, Rondônia, Brazil, 76834-899
        • Fundação PIO XII - Hospital de Amor Amazônia
    • Santa Catarina
      • Itajaí, 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
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784400
        • Fundacao PIO XII - Hospital de Amor
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G172
        • Cross Cancer Institute
    • 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
      • Antofagasta, Chile, 1240000
        • Centro Oncologico del Norte
      • Santiago, Chile, 8940575
        • Bradford Hill
    • Independencia
      • Santiago, Independencia, Chile, 8380456
        • Hospital Clínico Universidad de Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7560907
        • Centro Oncologia de Precision Universidad Mayor
      • Santiago, Santiago Metropolitan, Chile, Providencia
        • Oncovida
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Oncocentro Apys
  • Czechia
      • Ostrava, Czechia, 70852
        • University Hospital Ostrava
    • North Central Czech Republic
      • Hradec Králové, North Central Czech Republic, Czechia, 50005
        • University hospital Hradec Králové
    • Prague
      • Vinohrady, Prague, Czechia, 10034
        • Fn Kralovske Vinohrady, Dermatological Clinic
  • France
      • Boulogne, France, 92104
        • Hopital Ambroise Pare
      • Clermont-Ferrand, France, 63003
        • CHU Estaing
      • Lyon, France, 69008
        • Centre Leon Berard
      • Nantes, France, 44000
        • Nantes University Hospital
      • Strasbourg, France, 67000
        • Clinique Sainte Anne
    • Auvergne-Rhône-Alpes
      • Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69495
        • Hospices Civils de Lyon
    • Burgundy
      • Dijon, Burgundy, France, 21000
        • CHU-Dijon
    • Doubs
      • Besançon, Doubs, France, 25000
        • Besancon Regional University Hospital Center
    • Gironde
      • Bordeaux, Gironde, France, 33075
        • CHU de Bordeaux
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59000
        • Centre Hospitalier Universitaire (CHU) de Lille
    • Isere
      • La Tronche, Isere, France, 38700
        • Centre Hospitalier Universitaire Grenoble Alpes
    • New Aquitaine
      • Poitiers, New Aquitaine, France, 86000
        • Centre Hospitalier Universitaire de Poitiers
    • Normandy
      • Rouen, Normandy, France, 76031
        • CHU Charles Nicolle
    • Pays de la Loire Region
      • Le Mans, Pays de la Loire Region, France, 72037
        • Centre Hospitalier Le Mans
      • Saint Priest En Jarez, Pays de la Loire Region, France, 42270
        • CHU de St Etienne
    • Val de Marne / Ile de France
      • Villejuif, Val de Marne / Ile de France, France, 94805
        • Gustave Rroussy
    • Île-de-France Region
      • Bobigny, Île-de-France Region, France, 93000
        • Hopital Avicenne
      • Créteil, Île-de-France Region, France, 94000
        • Hospital Henri Mondor
      • Paris, Île-de-France Region, France, 75014
        • Cochin Hospital
  • 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
      • Tbilisi, Georgia, 0144
        • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
      • Tbilisi, Georgia, 186
        • ltd Multiprofile Clinic Consilium Medulla
  • Germany
      • Berlin, Germany, 10117
        • Charité Universitaetsmedizin Berlin
      • Göttingen, Germany, 37075
        • University Medical Center Göttingen
      • Schwerin, Germany, 19055
        • Helios Kliniken Schwerin
    • Baden-Wurttemberg
      • Mannheim, Baden-Wurttemberg, Germany, 68167
        • University Medical Center Mannheim
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • University of Tuebingen
    • Bavaria
      • Munich, Bavaria, Germany, 80337
        • LMU Klinikum
      • Nuremberg, Bavaria, Germany, 90408
        • Klinikum Nurnberg, Hautklinik, Universitatsklinik fur Dermatologie der Paracelsus Medizinischen Privatuniversitat
      • Regensburg, Bavaria, Germany, 93053
        • University Hospital of Regensburg
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • University Clinic Frankfurt
      • Giessen, Hesse, Germany, 35385
        • University Hospital Giessen
    • Lower Saxony
      • Buxtehude, Lower Saxony, Germany, 21614
        • Elbekliniken Stade Buxtehude
    • North Rhine-Westphalia
      • Bochum, North Rhine-Westphalia, Germany, 44791
        • Ruhr University Bochum
      • Münster, North Rhine-Westphalia, Germany, 48157
        • Fachklinik Hornheide
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Universitatsmedizin der Johannes-Gutenberg Universitat Mainz
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • University Hospital Dresden
      • Leipzig, Saxony, Germany, 04103
        • Universitatsklinikum Leipzig, AoR
    • Saxony-Anhalt
      • Dessau, Saxony-Anhalt, Germany, 06847
        • Dermatologie
      • 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
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Universitatsklinikum Schleswig Holstein Campus Luebeck
    • Thuringia
      • Erfurt, Thuringia, Germany, D-99089
        • Helios Klinikum Erfurt
  • Hungary
    • Baranya
      • Pécs, Baranya, Hungary, 7632
        • University of Pecs Medical School
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, H-4032
        • University of Debrecen
    • Szabolcs-Szatmár-Bereg
      • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
        • Szabolcs Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz
  • Ireland
      • Cork, Ireland, T12 EC8P
        • Cork University Hospital
      • Dublin, Ireland, D24NROA
        • Tallaght University Hospital
      • Dublin, Ireland, DO4YN63
        • St Vincents University Hospital
    • Connacht
      • Galway, Connacht, Ireland, H91 YR71
        • Galway University Hospital
  • Italy
      • Bari, Italy, 70124
        • Istituto dei Tumori
      • Brescia, Italy, 25123
        • Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia
      • Cuneo, Italy, 12100
        • Azienda Ospedaliera Santa Croce i Carle
      • Milan, Italy, 20141
        • Istituto Europeo di Oncologia
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori.
      • Monza, Italy, 20052
        • Universita Degli Studi Di Milano-Bicocca - Azienda Ospedaliera San Gerardo Di Monza
      • Naples, Italy, 80131
        • Istituto Nazionale Tumori IRCCS Fondazione G Pascale
      • Novara, Italy, 28100
        • Azienda Ospedaliero-Universitaria Maggiore della Carita - Oncology
      • Padova, Italy, 35128
        • Vento Institute of Oncology IOV-IRCCS
      • Rome, Italy, 00144
        • IRCCS Regina Elena National Cancer Institute
      • Rome, Italy, 00128
        • Campus Bio-Medico di Roma
      • Rome, Italy, 00167
        • Istituto Dermopatico dell'Immacolata
      • Torino, Italy, 10126
        • Aou Citta della Salute e della Scienza di Torino - SC Dermatologia U
      • Trento, Italy, 38122
        • Santa Chiara Hospital
      • Udine, Italy, 33100
        • Azienda Sanitaria Universitaria del Friuli Centrale
    • Campania
      • Naples, Campania, Italy, 80121
        • U.O.C. Oncologia Medica ed Ematologia (U.O.C Medical Oncology and Hematology)
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
        • IRCCS Casa Sollievo della Sofferenza
    • Liguria
      • Genoa, Liguria, Italy, 16132
        • IRCCS Ospedale Policlinico San Martino
    • Milan
      • Rozzano, Milan, Italy, 20089
        • Istituto Clinico Humanitas
    • Torino
      • Candiolo, Torino, Italy, 10060
        • FPO IRCCS Candiolo
    • Tuscany
      • Pisa, Tuscany, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Centro Estatal de Cancerologia
      • Veracruz, Mexico, 91910
        • FAICIC S. de R.L. de C.V.
    • Chiapas
      • Tuxtla Gutiérrez, Chiapas, Mexico, 29038
        • Centro De Estudios Y Prevention Del Cancer
    • Guanajuato
      • León, Guanajuato, Mexico, 37178
        • Preparaciones Oncologica SC
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
      • Zapopan, Jalisco, Mexico, 45070
        • Investigacion Biomedica para el Desarrollo de Farmacos SA de CV
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64710
        • iCan Oncology
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 80020
        • Neurociencias Estudios Clínicos SC
    • Yucatán
      • Mérida, Yucatán, Mexico, 97134
        • Centro De Atencion E Investigacion Clinica En Oncologia SCP
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Netherlands Cancer Institute
      • Groningen, Netherlands, 9713 GZ
        • University Medical Centre Groningen
  • Peru
      • Arequipa, Peru, 054
        • Centro Medico Monte Carmelo
      • Arequipa, Peru, 04000
        • Hospital Goyeneche
      • Lima, Peru, 15036.
        • Clinica Internacional SA
    • Departamento de Junín
      • Concepción, Departamento de Junín, Peru, 12125
        • Instituto Regional de Enfermedades Neoplasicas del Centro - IREN CENTRO
    • La Libertad
      • Trujillo, La Libertad, Peru, 13001
        • Clinica Peruano Americana (Private practice)
    • Lima region
      • San Borja, Lima region, Peru, 41
        • Clinica Oncosalud
      • Surquillo, Lima region, Peru, 34
        • Instituto Nacional de Enfermedades Neoplasicas
    • Provincia Constitucional del Callao
      • Lima, Provincia Constitucional del Callao, Peru, 07016
        • Hospital Nacional Daniel A. Carrion
  • Poland
      • Warsaw, Poland, 02-781
        • Maria Sklodowska-Curie National Research Institute of Oncology
    • Mazxowieckie
      • Siedlce, Mazxowieckie, Poland, 08-110
        • Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii
    • Pomeranian
      • Słupsk, Pomeranian, Poland, 76-200
        • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne (UCK)
    • Wielkopolska
      • Poznan, Wielkopolska, Poland, 60-788
        • Poznan University of Meidcla Science
  • Romania
      • Iași, Romania, 7000106
        • Centrul de Oncologie Euroclinic
      • Iași, Romania, 700383
        • Regional Institute of Oncology
    • Bucharest
      • Bucharest, Bucharest, Romania, 022328
        • Institute of Oncology Bucharest
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Cardiomed
      • Cluj-Napoca, Cluj, Romania, 400124
        • Medisprof
      • Floreşti, Cluj, Romania, 407280
        • Radiotherapy Center Cluj
    • Dolj
      • Craiova, Dolj, Romania, 200347
        • Sfantul Nectarie Oncology Center
    • Ilfov
      • Otopeni, Ilfov, Romania, 075100
        • SC RTC Radiology Therapeutic Center SRL
    • Timiș County
      • Timișoara, Timiș County, Romania, 300166
        • Oncocenter Oncologie clinica S.R.L
      • Timișoara, Timiș County, Romania, 300239
        • OncoMed
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2196
        • The Medical Oncology Centre of Rosebank
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Groote Schuur Hospital
      • Cape Town, Western Cape, South Africa, 7570
        • Cape Town Oncology Trials
  • Spain
      • Barcelona, Spain, 8025
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spain, 08908
        • Catalan Institute of Oncology (ICO) Hospitalet
      • Girona, Spain, 17007
        • Catalan Institute of Oncology
      • Granada, Spain, 18014
        • Hospital Universitario Virgen De Las Nieves
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Augusti
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain, 28046
        • Hospital Universitario La Pa<
      • Madrid, Spain, 28050
        • Centro Integral Oncologico HM Clara Campal
      • Málaga, Spain, 29011
        • Hospital Regional Universitario de Malaga
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncologia
      • Valencia, Spain, 46010
        • Incliva - Instituto de Investigacion Sanitaria
    • Andalusia
      • Córdoba, Andalusia, Spain, 14004
        • Hospital Universitario Reina Sofía
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • H. Germans Trias i Pujol, ICO-Badalona
    • Catalonia
      • Barcelona, Catalonia, Spain, 08028
        • Instituto Oncologico Dr Rosell Hospital Universitari Quiron Dexeus Location
    • Gipuzkoa
      • Donostia / San Sebastian, Gipuzkoa, Spain, 20014
        • Onkologikoa
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Hospital Clinico Universitario Virgen de La Arrixaca
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias
    • Spain/La Coruna
      • A Coruña, Spain/La Coruna, Spain, 15006
        • Hospital Teresa Herrera-Chuac
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06010
        • Gulhane Training and Research Hospital
      • Ankara, Turkey (Türkiye), 06100
        • Ozel Liv Hospital
      • Ankara, Turkey (Türkiye), 0906520
        • Memorial Ankara Hospital
      • Diyarbakır, Turkey (Türkiye), 21200
        • Dicle University - Medical Faculty Campus
      • Edirne, Turkey (Türkiye), 22030
        • Trakya University
      • Istanbul, Turkey (Türkiye), 34450
        • Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty
      • Istanbul, Turkey (Türkiye), 81450
        • Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital
    • Adana
      • Yüreğir, Adana, Turkey (Türkiye), 01230
        • Baskent University
    • Bakirkoy
      • Istanbul, Bakirkoy, Turkey (Türkiye), 34147
        • Medical oncology
    • Bornova
      • Izmir, Bornova, Turkey (Türkiye), 35100
        • Ege University
    • Kocaeli
      • İzmit, Kocaeli, Turkey (Türkiye), 41380
        • Kocaeli University
    • Sehitkamil
      • Gaziantep, Sehitkamil, Turkey (Türkiye), 27584
        • Gaziantep Medicalpoint Hospital
    • Turkey
      • Istanbul, Turkey, Turkey (Türkiye), 34093
        • Bezmialem University
  • United Kingdom
      • Guildford, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital NHS Trust
    • East Yorkshire
      • Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
        • Hull University Teaching Hospitals NHS Trust
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS6 2HA
        • Leeds Teaching Hospitals NHS Trust
  • United States
    • California
      • La Jolla, California, United States, 92093
        • UC San Diego
      • Los Angeles, California, United States, 90025
        • The Angeles Clinic and Research Institute
    • Florida
      • Orlando, Florida, United States, 32806
        • Orlando Health
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Seidman Cancer Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Age ≥12 years on the date of providing informed consent

  2. Patients with histologically confirmed unresectable Stage III and Stage IV (metastatic) melanoma (AJCC, 8th revised edition) who have not received prior systemic therapy for advanced unresectable disease

    1. Patients who received adjuvant and/or neoadjuvant systemic therapies are eligible if they did not have evidence of progression or recurrence of disease and/or discontinued due to occurrence of unmanageable imAEs ≥ grade 3 (with the exclusion of endocrinopathies which are fully controlled by hormone replacement) while on such therapies. Also, patients must have had a treatment-free and disease-free interval of >6 months. Accrual of these patients is limited to approximately 10% of the total population enrolled.
    2. Patients with acral and mucosal melanomas are eligible. Accrual will be limited to 10% of the total population.

  3. Measurable disease per RECIST v1.1

    1. Previously irradiated lesions can only be counted as target lesions if they have been demonstrated to progress and no other target lesion is available
    2. Cutaneous lesions should be evaluated as non-target lesions

  4. Performance status:

    1. For adult patients: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
    2. For pediatric patients: Karnofsky performance status ≥70 (patients ≥16 years) or Lansky performance status ≥70 (patients ≤16 years)
  5. Anticipated life expectancy of at least 3 months

Key Exclusion Criteria:

  1. Uveal melanoma
  2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.
  3. 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
  4. Unknown BRAF V600 mutation status as described in the protocol

  5. Systemic immune suppression:

    1. Use of immunosuppressive doses of corticosteroids (>10mg of prednisone per day or equivalent) within 14 days of the first dose of study medication. Physiologic replacement doses are allowed up to and including 10mg of prednisone/day or equivalent. Inhaled or topical steroids are permitted, if they are not for treatment of an autoimmune disorder.
    2. Other clinically relevant forms of systemic immune suppression
  6. Treatment with other anti-cancer therapy including immuno- therapy, chemotherapy, major surgery or biological therapy within 21 days prior to the first dose of trial treatment. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.
  7. History or current evidence of significant (CTCAE Grade ≥2) local or systemic infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 14 days prior to the first dose of trial medication.

  8. Active or untreated brain metastases or spinal cord compression. Patients with leptomeningeal disease are excluded. Patients with known brain metastases are eligible if they:

    1. Received radiotherapy or another appropriate standard therapy for the brain metastases,
    2. Have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment) for at least 14 days prior to enrollment
    3. Did not require immunosuppressive doses of corticosteroids therapy (>10mg of prednisone per day or equivalent) in the 14 days prior to enrollment
    4. Are asymptomatic with a single untreated brain metastasis <10 mm in size
  9. Participants with a history of myocarditis.

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A: fianlimab+cemiplimab dose 1
As defined in Protocol Amendment 5
Drug: Fianlimab
Intravenous (IV) infusion
Other Names:
  • REGN3767
Drug: Cemiplimab
IV infusion
Other Names:
  • REGN2810
  • Libtayo
Experimental: A1: fianlimab+cemiplimab dose 2
As defined in Protocol Amendment 5
Drug: Fianlimab
Intravenous (IV) infusion
Other Names:
  • REGN3767
Drug: Cemiplimab
IV infusion
Other Names:
  • REGN2810
  • Libtayo
Experimental: B: pembrolizumab+placebo
As defined in Protocol Amendment 5
Drug: Placebo
IV infusion
Drug: Pembrolizumab
IV infusion
Other Names:
  • Keytruda
  • lambrolizumab
  • MK-3475
Experimental: C: cemiplimab+placebo
As defined in Protocol Amendment 5
Drug: Placebo
IV infusion
Drug: Cemiplimab
IV infusion
Other Names:
  • REGN2810
  • Libtayo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Approximately 27 months
Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Blinded Independent Central Review (BICR)
Approximately 27 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to 96 months
Up to 96 months
Incidence of laboratory abnormalities
Time Frame: Up to 90 days post last dose, approximately 6 years
Will be graded using the current version of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading system (version 5.0)
Up to 90 days post last dose, approximately 6 years
Concentrations of cemiplimab in serum
Time Frame: Up to 90 days post last dose, approximately 6 years
Up to 90 days post last dose, approximately 6 years
Concentrations of fianlimab in serum
Time Frame: Up to 90 days post last dose, approximately 6 years
Up to 90 days post last dose, approximately 6 years
Incidence of anti-drug antibodies (ADA) to fianlimab over time
Time Frame: Up to 30 days post last dose, approximately 6 years
Up to 30 days post last dose, approximately 6 years
Titer of anti-drug antibodies (ADA) to fianlimab over time
Time Frame: Up to 30 days post last dose, approximately 6 years
Up to 30 days post last dose, approximately 6 years
Incidence of ADA to cemiplimab over time
Time Frame: Up to 30 days post last dose, approximately 6 years
Up to 30 days post last dose, approximately 6 years
Titer of ADA to cemiplimab over time
Time Frame: Up to 30 days post last dose, approximately 6 years
Up to 30 days post last dose, approximately 6 years
Incidence of neutralizing antibodies (NAb) to fianlimab over time
Time Frame: Up to 30 days post last dose, approximately 6 years
Up to 30 days post last dose, approximately 6 years
Incidence of NAb to cemiplimab over time
Time Frame: Up to 30 days post last dose, approximately 6 years
Up to 30 days post last dose, approximately 6 years
Patient-reported outcomes (PROs) as measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)
Time Frame: Up to 90 days post last dose, approximately 6 years
EORTC-QLQ-C30 is a 30-item participant 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.
Up to 90 days post last dose, approximately 6 years
PROs as measured by EQ-5D-5L
Time Frame: Up to 90 days post last dose, approximately 6 years
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. Overall scores range from 0 to 1, with low scores representing a higher level of dysfunction.
Up to 90 days post last dose, approximately 6 years
PROs as measured by Patient Global Impression of Severity (PGIS)
Time Frame: Up to 21 days post last dose, approximately 6 years
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 21 days post last dose, approximately 6 years
PROs as measured by Patient Global Impression of Change (PGIC)
Time Frame: Up to 21 days post last dose, approximately 6 years
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 21 days post last dose, approximately 6 years
Change in physical functioning per EORTC QLQ-C30
Time Frame: Baseline to Week 25
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.
Baseline to Week 25
Change in role functioning per EORTC QLQ-C30
Time Frame: Baseline to Week 25
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.
Baseline to Week 25
Change in global health status/quality of life (GHS/QoL) per EORTC QLQ-C30
Time Frame: Baseline to Week 25
Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). 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.
Baseline to Week 25
Change in physical functioning per EORTC QLQ-C30
Time Frame: Baseline to end of study, approximately 6 years
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.
Baseline to end of study, approximately 6 years
Change in role functioning per EORTC QLQ-C30
Time Frame: Baseline to end of study, approximately 6 years
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.
Baseline to end of study, approximately 6 years
Change in GHS/QoL per EORTC QLQ-C30
Time Frame: Baseline to end of study, approximately 6 years
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.
Baseline to end of study, approximately 6 years
Occurrence of interruption and discontinuation of study drug(s) due to AEs
Time Frame: Up to 90 days post last dose, approximately 6 years
Including TEAEs, AESIs, and/ or imAEs
Up to 90 days post last dose, approximately 6 years
PROs as measured by Functional Assessment of Cancer Therapy melanoma (FACTM) (melanoma subscale only)
Time Frame: Up to 90 days post last dose, approximately 6 years
The FACTM is a melanoma-specific quality of life questionnaire that is composed of items from the Functional Assessment of Cancer Therapy-General (FACT-G). The FACTM 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 90 days post last dose, approximately 6 years
Objective response rate (ORR)
Time Frame: Up to 27 months
Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Blinded Independent Central Review (BICR) or based on investigator assessment according to RECIST 1.1
Up to 27 months
Disease control rate (DCR)
Time Frame: Up to 27 months
Per RECIST 1.1 based on BICR or based on investigator assessment according to RECIST 1.1
Up to 27 months
Duration of response (DoR)
Time Frame: Up to 27 months
Per RECIST 1.1 via BICR or based on investigator assessment according to RECIST 1.1
Up to 27 months
PFS
Time Frame: Up to 27 months
Based on investigator assessment according to RECIST 1.1
Up to 27 months
Incidence of Adverse Events (AEs)
Time Frame: Up to 90 days post last dose, approximately 6 years
Including treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and/ or immune-mediated adverse events (imAEs)
Up to 90 days post last dose, approximately 6 years
TEAEs leading to death
Time Frame: Up to 6 years
Up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2022

Primary Completion (Actual)

March 12, 2026

Study Completion (Estimated)

September 16, 2031

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

April 25, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R3767-ONC-2011
  • 2021-004453-23 (EudraCT Number)
  • 2023-505772-30-00 (Ctis: 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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