AzTrials
AzTrials

MelanomaPhase 3NCT05352672

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

A Phase 3 study testing Fianlimab, Cemiplimab and Pembrolizumab in people with Melanoma, run by Regeneron Pharmaceuticals at 210 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Melanoma
What is being tested?
Fianlimab, Cemiplimab and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,546 participants
Where
210 sitesin 24 countries
Study dates
14 Jul 2022to 16 Sep 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age ≥12 years on the date of providing informed consent
  • 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
  • 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.
  • Patients with acral and mucosal melanomas are eligible. Accrual will be limited to 10% of the total population.
  • Measurable disease per RECIST v1.1
  • Previously irradiated lesions can only be counted as target lesions if they have been demonstrated to progress and no other target lesion is available
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  • Cutaneous lesions should be evaluated as non-target lesions
  • Performance status:
  • For adult patients: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • For pediatric patients: Karnofsky performance status ≥70 (patients ≥16 years) or Lansky performance status ≥70 (patients ≤16 years)
  • Anticipated life expectancy of at least 3 months

Who cannot join

  • Uveal melanoma
  • 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.
  • 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
  • Unknown BRAF V600 mutation status as described in the protocol
  • Systemic immune suppression:
  • 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.
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  • Other clinically relevant forms of systemic immune suppression
  • 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.
  • 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.
  • Active or untreated brain metastases or spinal cord compression. Patients with leptomeningeal disease are excluded. Patients with known brain metastases are eligible if they:
  • Received radiotherapy or another appropriate standard therapy for the brain metastases,
  • Have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment) for at least 14 days prior to enrollment
  • Did not require immunosuppressive doses of corticosteroids therapy (>10mg of prednisone per day or equivalent) in the 14 days prior to enrollment
  • Are asymptomatic with a single untreated brain metastasis <10 mm in size
  • Participants with a history of myocarditis.
  • Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Trial locations and contacts

210 sites in 24 countries.

210 sites in 24 countries

Germany21 sites

  • Charite Universitaetsmedizin Berlin

    Berlin, 10117

  • Ruhr University Bochum

    Bochum, North Rhine-Westphalia, 44791

  • Elbekliniken Stade Buxtehude

    Buxtehude, Lower Saxony, 21614

  • Dermatologie

    Dessau, Saxony-Anhalt, 06847

  • University Hospital Dresden

    Dresden, Saxony, 01307

  • Helios Klinikum Erfurt

    Erfurt, Thuringia, D-99089

  • University Clinic Frankfurt

    Frankfurt am Main, Hesse, 60590

  • University Hospital Giessen

    Giessen, Hesse, 35385

  • University Medical Center Gottingen

    Göttingen, 37075

  • University Hospital of Universitatsklinikum Schleswig Holstein (UKSH) Campus Kiel

    Kiel, Schleswig-Holstein, 24105

  • Universitatsklinikum Leipzig, AoR

    Leipzig, Saxony, 04103

  • Universitatsklinikum Schleswig Holstein Campus Luebeck

    Lübeck, Schleswig-Holstein, 23538

  • Universitatsmedizin der Johannes-Gutenberg Universitat Mainz

    Mainz, Rhineland-Palatinate, 55131

  • University Medical Center Mannheim

    Mannheim, Baden-Wurttemberg, 68167

  • LMU Klinikum

    Munich, Bavaria, 80337

  • Fachklinik Hornheide

    Münster, North Rhine-Westphalia, 48157

  • Klinikum Nurnberg, Hautklinik, Universitatsklinik fur Dermatologie der Paracelsus Medizinischen Privatuniversitat

    Nuremberg, Bavaria, 90408

  • Skin Cancer Center Harz

    Quedlinburg, Saxony-Anhalt, 06484

  • University Hospital of Regensburg

    Regensburg, Bavaria, 93053

  • Helios Kliniken Schwerin

    Schwerin, 19055

  • University of Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Italy21 sites

  • Istituto dei Tumori

    Bari, 70124

  • Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia

    Brescia, 25123

  • FPO IRCCS Candiolo

    Candiolo, Torino, 10060

  • Azienda Ospedaliera Santa Croce i Carle

    Cuneo, 12100

  • IRCCS Ospedale Policlinico San Martino

    Genoa, Liguria, 16132

  • Fondazione IRCCS Istituto Nazionale dei Tumori.

    Milan, 20133

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Universita Degli Studi Di Milano-Bicocca - Azienda Ospedaliera San Gerardo Di Monza

    Monza, 20052

  • U.O.C. Oncologia Medica ed Ematologia (U.O.C Medical Oncology and Hematology)

    Naples, Campania, 80121

  • Istituto Nazionale Tumori IRCCS Fondazione G Pascale

    Naples, 80131

  • Azienda Ospedaliero-Universitaria Maggiore della Carita - Oncology

    Novara, 28100

  • Vento Institute of Oncology IOV-IRCCS

    Padova, 35128

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56126

  • Campus Bio-Medico di Roma

    Rome, 00128

  • IRCCS Regina Elena National Cancer Institute

    Rome, 00144

  • Istituto Dermopatico dell'Immacolata

    Rome, 00167

  • Istituto Clinico Humanitas

    Rozzano, Milan, 20089

  • IRCCS Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia, 71013

  • Aou Citta della Salute e della Scienza di Torino - SC Dermatologia U

    Torino, 10126

  • Santa Chiara Hospital

    Trento, 38122

  • Azienda Sanitaria Universitaria del Friuli Centrale

    Udine, 33100

Other trials in Italy

Spain21 sites

  • Hospital Teresa Herrera-Chuac

    A Coruña, Spain/La Coruna, 15006

  • H. Germans Trias i Pujol, ICO-Badalona

    Badalona, Barcelona, 08916

  • Instituto Oncologico Dr Rosell Hospital Universitari Quiron Dexeus Location

    Barcelona, Catalonia, 08028

  • Catalan Institute of Oncology (ICO) Hospitalet

    Barcelona, 08908

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8025

  • Hospital Universitario Reina Sofia

    Córdoba, Andalusia, 14004

  • Onkologikoa

    Donostia / San Sebastian, Gipuzkoa, 20014

  • Hospital Clinico Universitario Virgen De La Arrixaca

    El Palmar, Murcia, 30120

  • Catalan Institute Of Oncology

    Girona, 17007

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • Hospital Universitario Lucus Augusti

    Lugo, 27003

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario La Pa<

    Madrid, 28046

  • Centro Integral Oncologico HM Clara Campal

    Madrid, 28050

  • Hospital Regional Universitario de Malaga

    Málaga, 29011

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Instituto Valenciano de Oncologia

    Valencia, 46009

  • Incliva - Instituto de Investigacion Sanitaria

    Valencia, 46010

Other trials in Spain

Brazil20 sites

  • Fundacao Pio XII - Hospital de Amor

    Barretos, São Paulo, 14784400

  • Hospital das Clinicas da Universidade Federal de Minas Gerais

    Belo Horizonte, Minas Gerais, 30130-090

  • Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060

  • Oncosite Centro De Pesquisa Em Oncologia

    Ijuí, 98700-000

  • Catarina Pesquisa Clinica

    Itajaí, Santa Catarina, 88301-220

  • Instituto Joinvilense de Hematologia e Oncologia

    Joinville, Santa Catarina, 89201260

  • Animi Unidade de Tratamento Oncologico

    Lages, Santa Catarina, 88501-001

  • Hospital Bruno Born

    Lajeado, Rio Grande do Sul, 95900-022

  • Instituto do Cancer em Hospital Sao Vicente de Paulo

    Passo Fundo, Rio Grande do Sul, 99010-090

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035007

  • Hospital Moinhos de vento

    Porto Alegre, Rio Grande do Sul, 90440140

  • Centro de Pesquisa em Oncologia PUCRS

    Porto Alegre, Rio Grande do Sul, 90619900

  • Fundacao Pio XII - Hospital de Amor Amazonia

    Porto Velho, Rondônia, 76834-899

  • INCA - Brazilian National Cancer Institute

    Rio de Janeiro, 20220-280

  • Instituto COI

    Rio de Janeiro, 23793-080

  • Hospital Sao Rafael

    Salvador, Estado de Bahia, 41253900

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

  • Hemomed

    São Paulo, 01236030

  • Hospital Sirio Libanes

    São Paulo, 01308-050

  • Sao Camilo Oncologia

    São Paulo, 04014-002

Other trials in Brazil

France19 sites

  • Besancon Regional University Hospital Center

    Besançon, Doubs, 25000

  • Hopital Avicenne

    Bobigny, Île-de-France Region, 93000

  • Chu De Bordeaux

    Bordeaux, Gironde, 33075

  • Hopital Ambroise Pare

    Boulogne, 92104

  • CHU Estaing

    Clermont-Ferrand, 63003

  • Hospital Henri Mondor

    Créteil, Île-de-France Region, 94000

  • CHU-Dijon

    Dijon, Burgundy, 21000

  • Centre Hospitalier Universitaire Grenoble Alpes

    La Tronche, Isere, 38700

  • Centre Hospitalier Le Mans

    Le Mans, Pays de la Loire Region, 72037

  • Centre Hospitalier Universitaire (CHU) de Lille

    Lille, Hauts-de-France, 59000

  • Centre Leon Berard

    Lyon, 69008

  • Nantes University Hospital

    Nantes, 44000

  • Cochin Hospital

    Paris, Île-de-France Region, 75014

  • Hospices Civils de Lyon

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

  • Centre Hospitalier Universitaire De Poitiers

    Poitiers, New Aquitaine, 86000

  • CHU Charles Nicolle

    Rouen, Normandy, 76031

  • CHU de St Etienne

    Saint Priest En Jarez, Pays de la Loire Region, 42270

  • Clinique Sainte Anne

    Strasbourg, 67000

  • Gustave Rroussy

    Villejuif, Val de Marne / Ile de France, 94805

Other trials in France

Turkey (Türkiye)13 sites

  • Gulhane Training and Research Hospital

    Ankara, 06010

  • Ozel Liv Hospital

    Ankara, 06100

  • Memorial Ankara Hospital

    Ankara, 0906520

  • Dicle University - Medical Faculty Campus

    Diyarbakır, 21200

  • Trakya University

    Edirne, 22030

  • Gaziantep Medicalpoint Hospital

    Gaziantep, Sehitkamil, 27584

  • Medical oncology

    Istanbul, Bakirkoy, 34147

  • Bezmialem University

    Istanbul, Turkey, 34093

  • Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty

    Istanbul, 34450

  • Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital

    Istanbul, 81450

  • Ege University

    Izmir, Bornova, 35100

  • Kocaeli University

    İzmit, Kocaeli, 41380

  • Baskent University

    Yüreğir, Adana, 01230

Other trials in Turkey (Türkiye)

Romania10 sites

  • Institute of Oncology Bucharest

    Bucharest, Bucharest, 022328

  • Cardiomed

    Cluj-Napoca, Cluj, 400015

  • Medisprof

    Cluj-Napoca, Cluj, 400124

  • Sfantul Nectarie Oncology Center

    Craiova, Dolj, 200347

  • Radiotherapy Center Cluj

    Floreşti, Cluj, 407280

  • Centrul De Oncologie Euroclinic

    Iași, 7000106

  • Regional Institute of Oncology

    Iași, 700383

  • SC RTC Radiology Therapeutic Center SRL

    Otopeni, Ilfov, 075100

  • Oncocenter Oncologie Clinica S.R.L

    Timișoara, Timiș County, 300166

  • Oncomed

    Timișoara, Timiș County, 300239

Other trials in Romania

Mexico9 sites

  • Centro Estatal de Cancerologia

    Chihuahua City, 31000

  • Neurociencias Estudios Clinicos SC

    Culiacán, Sinaloa, 80020

  • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, Jalisco, 44280

  • Preparaciones Oncologica SC

    León, Guanajuato, 37178

  • Centro De Atencion E Investigacion Clinica En Oncologia SCP

    Mérida, Yucatán, 97134

  • iCan Oncology

    Monterrey, Nuevo León, 64710

  • Centro De Estudios Y Prevention Del Cancer

    Tuxtla Gutiérrez, Chiapas, 29038

  • FAICIC S. de R.L. de C.V.

    Veracruz, 91910

  • Investigacion Biomedica para el Desarrollo de Farmacos SA de CV

    Zapopan, Jalisco, 45070

Other trials in Mexico

Georgia8 sites

  • Cancer Center of Adjara

    Batumi, 6000

  • Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine

    Tbilisi, 0112

  • Israeli Georgian Medical Research Clinic Helsicore

    Tbilisi, 0112

  • LTD New Hospitals

    Tbilisi, 0114

  • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

    Tbilisi, 0144

  • JSC K. Eristavi National Center of Experimental and Clinical Surgery

    Tbilisi, 0159

  • TIM - Tbilisi Institute of Medicine

    Tbilisi, 0160

  • ltd Multiprofile Clinic Consilium Medulla

    Tbilisi, 186

Other trials in Georgia

Peru8 sites

  • Hospital Goyeneche

    Arequipa, 04000

  • Centro Medico Monte Carmelo

    Arequipa, 054

  • Instituto Regional de Enfermedades Neoplasicas del Centro - IREN CENTRO

    Concepción, Departamento de Junín, 12125

  • Hospital Nacional Daniel A. Carrion

    Lima, Provincia Constitucional del Callao, 07016

  • Clinica Internacional SA

    Lima, 15036.

  • Clinica Oncosalud

    San Borja, Lima region, 41

  • Instituto Nacional de Enfermedades Neoplasicas

    Surquillo, Lima region, 34

  • Clinica Peruano Americana (Private practice)

    Trujillo, La Libertad, 13001

Other trials in Peru

Argentina6 sites

  • Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion)

    Buenos Aires, 1125

  • DIABAID - Instituto de Asistencia Integral en Diabetes

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1061

  • Centro Medico Austral

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1408

  • Centro de Investigacion Pergamino

    Pergamino, Buenos Aires, B2700CPM

  • Instituto de Oncologia de Rosario

    Rosario, Santa Fe Province, S2000KZE

  • Exelsus

    San Miguel de Tucumán, 4000

Other trials in Argentina

Australia6 sites

  • Andrew Love Cancer Centre

    Geelong, Victoria, 3220

  • Icon Cancer Centre Hobart

    Hobart, Tasmania, 7000

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Calvary North Adelaide Hospital

    North Adelaide, South Australia, 5006

  • Gold Coast Hospital and Health Service

    Southport, Queensland, 4215

  • Townsville University Hospital

    Townsville, Queensland, 4814

Other trials in Australia

Chile6 sites

  • Centro Oncologico del Norte

    Antofagasta, 1240000

  • Hospital Clinico Universidad de Chile

    Santiago, Independencia, 8380456

  • Centro Oncologia de Precision Universidad Mayor

    Santiago, Santiago Metropolitan, 7560907

  • Oncovida

    Santiago, Santiago Metropolitan, Providencia

  • Bradford Hill

    Santiago, 8940575

  • Oncocentro APYS

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

United States5 sites

  • Seidman Cancer Center

    Cleveland, Ohio, 44106

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • UC San Diego

    La Jolla, California, 92093

  • The Angeles Clinic and Research Institute

    Los Angeles, California, 90025

  • Orlando Health

    Orlando, Florida, 32806

Other trials in United States

Canada5 sites

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G172

  • Dr. Everett Chalmers Hospital

    Fredericton, New Brunswick, E3B 5N5

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Poland5 sites

  • Uniwersyteckie Centrum Kliniczne (UCK)

    Gdansk, Pomeranian Voivodeship, 80-214

  • Poznan University of Meidcla Science

    Poznan, Wielkopolska, 60-788

  • Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii

    Siedlce, Mazxowieckie, 08-110

  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.

    Słupsk, Pomeranian, 76-200

  • Maria Sklodowska-Curie National Research Institute of Oncology

    Warsaw, 02-781

Other trials in Poland

Austria4 sites

  • Medical University of Graz

    Graz, Styria, 8036

  • Medical University Innsbruck

    Innsbruck, Tyrol, 6020

  • University Hospital Saint Poelten

    Sankt Pölten, Lower Austria, 3100

  • Medical University Vienna

    Vienna, 1090

Other trials in Austria

Belgium4 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • AZ Groeninge

    Kortrijk, West-Vlaanderen, 8500

  • Centre Hospitalier Universitaire Universite Catholique de Louvain Namur Site Sainte Elisabeth

    Namur, B5000

  • AZ Nikolaas

    Sint-Niklaas, West-Vlaanderen, 9100

Other trials in Belgium

Ireland4 sites

  • Cork University Hospital

    Cork, T12 EC8P

  • Tallaght University Hospital

    Dublin, D24NROA

  • St Vincents University Hospital

    Dublin, DO4YN63

  • Galway University Hospital

    Galway, Connacht, H91 YR71

Other trials in Ireland

United Kingdom4 sites

  • Hull University Teaching Hospitals NHS Trust

    Cottingham, East Yorkshire, HU16 5JQ

  • Royal Devon and Exeter Hospital NHS Trust

    Exeter, Devon, EX2 5DW

  • Royal Surrey County Hospital

    Guildford, GU2 7XX

  • Leeds Teaching Hospitals NHS Trust

    Leeds, West Yorkshire, LS6 2HA

Other trials in United Kingdom

Czechia3 sites

  • University Hospital Hradec Kralove

    Hradec Králové, North Central Czech Republic, 50005

  • University Hospital Ostrava

    Ostrava, 70852

  • Fn Kralovske Vinohrady, Dermatological Clinic

    Vinohrady, Prague, 10034

Other trials in Czechia

Hungary3 sites

  • University of Debrecen

    Debrecen, Hajdú-Bihar, H-4032

  • Szabolcs Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • University of Pecs Medical School

    Pécs, Baranya, 7632

Other trials in Hungary

South Africa3 sites

  • Cape Town Oncology Trials

    Cape Town, Western Cape, 7570

  • Groote Schuur Hospital

    Cape Town, Western Cape, 7925

  • The Medical Oncology Centre of Rosebank

    Johannesburg, Gauteng, 2196

Other trials in South Africa

Netherlands2 sites

  • Netherlands Cancer Institute

    Amsterdam, 1066 CX

  • University Medical Centre Groningen

    Groningen, 9713 GZ

Other trials in Netherlands

About this study

Official title: 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.

Read more

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
Conditions
Melanoma
Being tested
Fianlimab, Cemiplimab, Pembrolizumab, Placebo
Keywords
Unresectable, Metastatic, Stage III, Stage IV, Anti-Lymphocyte-activation gene 3 Pathway (LAG-3)
Medical subject headings
Melanoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FianlimabDrug

    Also called REGN3767

    Intravenous (IV) infusion

  • CemiplimabDrug

    Also called REGN2810, Libtayo

    IV infusion

  • PembrolizumabDrug

    Also called MK-3475, lambrolizumab, Keytruda

    IV infusion

  • PlaceboDrug

    IV infusion

Study groups in NCT05352672
Study groupRoleWhat they receive
A: fianlimab+cemiplimab dose 1ExperimentalAs defined in Protocol Amendment 5
Receives: Drug: Fianlimab; Drug: Cemiplimab
A1: fianlimab+cemiplimab dose 2ExperimentalAs defined in Protocol Amendment 5
Receives: Drug: Fianlimab; Drug: Cemiplimab
B: pembrolizumab+placeboExperimentalAs defined in Protocol Amendment 5
Receives: Drug: Pembrolizumab; Drug: Placebo
C: cemiplimab+placeboExperimentalAs defined in Protocol Amendment 5
Receives: Drug: Cemiplimab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Blinded Independent Central Review (BICR)

    Measured: Approximately 27 months

Secondary outcomes (28)

  1. Overall survival (OS)

    Measured: Up to 96 months

  2. Objective response rate (ORR)

    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

    Measured: Up to 27 months

  3. Disease control rate (DCR)

    Per RECIST 1.1 based on BICR or based on investigator assessment according to RECIST 1.1

    Measured: Up to 27 months

  4. Duration of response (DoR)

    Per RECIST 1.1 via BICR or based on investigator assessment according to RECIST 1.1

    Measured: Up to 27 months

  5. PFS

    Based on investigator assessment according to RECIST 1.1

    Measured: Up to 27 months

  6. Incidence of Adverse Events (AEs)

    Including treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and/ or immune-mediated adverse events (imAEs)

    Measured: Up to 90 days post last dose, approximately 6 years

  7. Occurrence of interruption and discontinuation of study drug(s) due to AEs

    Including TEAEs, AESIs, and/ or imAEs

    Measured: Up to 90 days post last dose, approximately 6 years

  8. TEAEs leading to death

    Measured: Up to 6 years

  9. Incidence of laboratory abnormalities

    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)

    Measured: Up to 90 days post last dose, approximately 6 years

  10. Concentrations of cemiplimab in serum

    Measured: Up to 90 days post last dose, approximately 6 years

  11. Concentrations of fianlimab in serum

    Measured: Up to 90 days post last dose, approximately 6 years

  12. Incidence of anti-drug antibodies (ADA) to fianlimab over time

    Measured: Up to 30 days post last dose, approximately 6 years

  13. Titer of anti-drug antibodies (ADA) to fianlimab over time

    Measured: Up to 30 days post last dose, approximately 6 years

  14. Incidence of ADA to cemiplimab over time

    Measured: Up to 30 days post last dose, approximately 6 years

  15. Titer of ADA to cemiplimab over time

    Measured: Up to 30 days post last dose, approximately 6 years

  16. Incidence of neutralizing antibodies (NAb) to fianlimab over time

    Measured: Up to 30 days post last dose, approximately 6 years

  17. Incidence of NAb to cemiplimab over time

    Measured: Up to 30 days post last dose, approximately 6 years

  18. Patient-reported outcomes (PROs) as measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)

    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.

    Measured: Up to 90 days post last dose, approximately 6 years

  19. PROs as measured by EQ-5D-5L

    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.

    Measured: Up to 90 days post last dose, approximately 6 years

  20. PROs as measured by Functional Assessment of Cancer Therapy melanoma (FACTM) (melanoma subscale only)

    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).

    Measured: Up to 90 days post last dose, approximately 6 years

  21. PROs as measured by Patient Global Impression of Severity (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".

    Measured: Up to 21 days post last dose, approximately 6 years

  22. PROs as measured by Patient Global Impression of Change (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"

    Measured: Up to 21 days post last dose, approximately 6 years

  23. Change in physical functioning per EORTC QLQ-C30

    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.

    Measured: Baseline to Week 25

  24. Change in role functioning per EORTC QLQ-C30

    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.

    Measured: Baseline to Week 25

  25. Change in global health status/quality of life (GHS/QoL) per EORTC QLQ-C30

    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.

    Measured: Baseline to Week 25

  26. Change in physical functioning per EORTC QLQ-C30

    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.

    Measured: Baseline to end of study, approximately 6 years

  27. Change in role functioning per EORTC QLQ-C30

    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.

    Measured: Baseline to end of study, approximately 6 years

  28. Change in GHS/QoL per EORTC QLQ-C30

    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.

    Measured: Baseline to end of study, approximately 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2022
  2. Study start14 Jul 2022
  3. Primary completion12 Mar 2026
  4. Study completion16 Sep 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,546 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05352672
Sponsor's protocol ID
R3767-ONC-2011
Other IDs
2021-004453-23, 2023-505772-30-00, 2023
Status last verified
Apr 2026
First submitted
6 Apr 2022
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Publications

  • Bautista J, Echeverria CE, Maldonado-Noboa I, Adatty-Molina J, Suarez Urresta S, Coral-Riofrio EC, Araujo-Abad S, Kyriakidis NC, Lopez-Cortes A. Next-Generation Immune Checkpoints and Tumor Microenvironment Modulation in Cancer Immunotherapy. J Immunol Res. 2026;2026(1):e7864229. doi: 10.1155/jimr/7864229.

    PubMed 41811823

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fianlimab, Cemiplimab and Pembrolizumab in people with Melanoma, run by Regeneron Pharmaceuticals at 210 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 210 sites in Germany, Italy, Spain, Brazil, France and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Approximately 27 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05352672, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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