AzTrials
AzTrials

MelanomaPhase 3NCT05608291

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 study testing Fianlimab, Cemiplimab and Pembrolizumab in people with Melanoma, run by Regeneron Pharmaceuticals at 211 sites in 22 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 cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with an approved medication called pembrolizumab. 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
1,564 participants
Where
211 sitesin 22 countries
Study dates
16 Jan 2023to 3 Apr 2030
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

  • 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
  • Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery
  • 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

Who cannot join

  • Uveal melanoma
  • Any evidence of residual disease after surgery by imaging, pathology, or cytology.
  • Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required treatment
  • 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
  • Another malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocol
  • Participants with a history of myocarditis
  • Adolescent patients (≥12 to <18 years old) with body weight <40 kg
  • Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Trial locations and contacts

211 sites in 22 countries.

211 sites in 22 countries

United States28 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22903

  • Northwestern University

    Chicago, Illinois, 60611

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • The Ohio State University James Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Duke Cancer Institute, University Hospital

    Durham, North Carolina, 27710

  • St Lukes University Health Network

    Easton, Pennsylvania, 18045

  • The Melanoma And Skin Cancer Institute

    Englewood, Colorado, 80113

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • UC San Diego

    La Jolla, California, 92093

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida, 33176

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Tennessee Oncology - Centennial Clinic Location

    Nashville, Tennessee, 37203-1625

  • Verdi Oncology

    Nashville, Tennessee, 37203

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

  • Columbia University

    New York, New York, 10032

  • Orlando Health

    Orlando, Florida, 32806

  • University Of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • University of Rochester

    Rochester, New York, 14642

  • UCSF Medical Center at Mission Bay

    San Francisco, California, 94158

  • John Wayne Cancer Institute (JWCI)

    Santa Monica, California, 90404

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

Germany22 sites

  • University Hospital Augsburg

    Augsburg, Bavaria, 86179

  • Charite Universitaetsmedizin Berlin

    Berlin, 10117

  • Ruhr University Bochum

    Bochum, North Rhine-Westphalia, 44791

  • Klinikum Bremen Ost

    Bremen, 28325

  • Klinikum Darmstadt GmbH

    Darmstadt, Hesse, 64283

  • University Hospital Dresden

    Dresden, Saxony, 01307

  • Helios Klinikum Erfurt

    Erfurt, Thuringia, D-99089

  • Dermatology Erlangen

    Erlangen, Bavaria, 91054

  • Universitatsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

  • University Clinic Frankfurt

    Frankfurt am Main, Hesse, 60590

  • University Medical Center Goettingen

    Göttingen, Lower Saxony, 37075

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

    Kiel, Schleswig-Holstein, 24105

  • Universitatsklinikum Schleswig Holstein Campus Luebeck

    Lübeck, Schleswig-Holstein, 23538

  • Hautklinik

    Ludwigshafen am Rhein, Rhineland-Palatinate, D-67063

  • University Medical Center Mannheim

    Mannheim, Baden-Wurttemberg, 68167

  • LMU Klinikum

    Munich, Bavaria, 80337

  • University Hospital Muenster

    Münster, North Rhine-Westphalia, 48149

  • Fachklinik Hornheide

    Münster, North Rhine-Westphalia, 48157

  • Skin Cancer Center Harz

    Quedlinburg, Saxony-Anhalt, 06484

  • University Hospital of Regensburg

    Regensburg, Bavaria, 93053

  • Helios Kliniken Schwerin

    Schwerin, Mecklenburg-Vorpommern, 19055

  • University of Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

France21 sites

  • CHU Amiens-Picardie

    Amiens, Picardie, 80000

  • Sainte Catherine Institut du Cancer Avignon Provence

    Avignon, 84918

  • Besancon Regional University Hospital Center

    Besançon, Doubs, 25000

  • Hopital Avicenne

    Bobigny, Île-de-France Region, 93000

  • Chu De Bordeaux

    Bordeaux, Gironde, 33075

  • N_Hôpital Ambroise-Paré

    Boulogne-Billancourt, 92100

  • Centre Francois Baclesse (CFB)

    Caen, Normandy, 14076

  • CHU Estaing

    Clermont-Ferrand, 63003

  • Hospital Henri Mondor

    Créteil, Île-de-France Region, 94000

  • Centre Georges Francois Leclerc

    Dijon, Bourgogne-Franche-Comté, 21000

  • 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

  • CHU de Lille

    Lille, Hauts-de-France, 59000

  • Service de Dermatologie CHU Saint Eloi

    Montpellier, Herault, 34295

  • Nantes University Hospital

    Nantes, Pays de la Loire Region, 44093

  • Centre Hospitalier Universitaire De Nice Hopital De L Archet

    Nice, 06202

  • Saint Louis Hospital

    Paris, Île-de-France Region, 75010

  • Institut Claudius Regaud, IUCT-Oncopole

    Toulouse, Haute-Garonne, 31059

  • Centre Hospitalier de Valence

    Valence, 26000

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Brazil18 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, Rio Grande do Sul, 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

  • 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

  • Instituto COI

    Rio de Janeiro, 23793-080

  • INCA Instituto Nacional de Cancer

    Santo Cristo, Rio de Janeiro, 20220-410

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base

    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

  • Unimed Sorocaba

    Sorocaba, São Paulo, 18052-210

Other trials in Brazil

Spain16 sites

  • H. Germans Trias i Pujol, ICO-Badalona

    Badalona, Barcelona, 08916

  • Instituto Oncologico Dr Rosell Hospital Universitari Quiron Dexeus Location

    Barcelona, Catalonia, 08028

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Catalan Institute of Oncology (ICO) Hospitalet

    Barcelona, 08908

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • Hospital Universitario Lucus Augusti

    Lugo, 27003

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM

    Madrid, 28041

  • Hospital Universitario La Pa<

    Madrid, 28046

  • Centro Integral Oncologico HM Clara Campal

    Madrid, 28050

  • Hospital Universitario Central De Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Instituto Valenciano de Oncologia

    Valencia, 46009

  • Incliva - Instituto de Investigacion Sanitaria

    Valencia, 46010

Other trials in Spain

Italy14 sites

  • Clinica Oncologica, AOU Riuniti Ancona

    Ancona, An, 60020

  • Istituto dei Tumori

    Bari, 70124

  • Azienda Ospedaliera Santa Croce i Carle

    Cuneo, 12100

  • Istituto Romagnolo per lo Studio dei Tumori (IRST)

    Meldola, Forli Cesena, 47014

  • Istituto Clinico Humanitas

    Milan, Lombardy, 20089

  • Istituto Europeo di Oncologia

    Milan, 20141

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

    Naples, Campania, 80121

  • Instituto Nazionale Tumori Fondazione Giovanni Pascale

    Naples, 80131

  • University of Perugia

    Perugia, 06132

  • Fondazione Policlinico Universitrio a. Gemelli - IRCCS

    Rome, 000168

  • Campus Bio-Medico di Roma

    Rome, 00128

  • Istituto Dermopatico dell'Immacolata

    Rome, 00167

  • Santa Chiara Hospital

    Trento, 38122

  • Azienda Sanitaria Universitaria del Friuli Centrale

    Udine, 33100

Other trials in Italy

Turkey (Türkiye)11 sites

  • Gulhane Research And Training Hospital

    Ankara, 06010

  • Ozel Liv Hospital

    Ankara, 06100

  • Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam

    Ankara, 06100

  • Memorial Ankara Hospital

    Ankara, 0906520

  • Trakya University

    Edirne, 22030

  • Gaziantep Medicalpoint Hospital

    Gaziantep, Sehitkamil, 27584

  • Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty

    Istanbul, 34450

  • Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital

    Istanbul, 81450

  • Kocaeli University

    İzmit, Kocaeli, 41380

  • Dicle University - Medical Faculty Campus

    Sur, Diyarbakır, 21200

  • Baskent University

    Yüreğir, Adana, 01230

Other trials in Turkey (Türkiye)

Australia10 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Blacktown Cancer and Haematology Centre - Blacktown Hospital

    Blacktown, New South Wales, 2148

  • Eastern Health

    Box Hill, Victoria, 3128

  • Andrew Love Cancer Centre

    Geelong, Victoria, 3220

  • Lismore Base Hospital

    Lismore, New South Wales, 2480

  • Liverpool Hospital - Cancer Therapy Centre

    Liverpool, New South Wales, 2170

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • One Clinical Research at Hollywood Private Hospital

    Nedlands, Western Australia, 6009

  • Calvary North Adelaide Hospital

    North Adelaide, South Australia, 5006

  • Melanoma Institute of Australia

    Wollstonecraft, New South Wales, 2065

Other trials in Australia

United Kingdom9 sites

  • Bristol Haematology And Oncology Centre (BHOC) - Bristol Cancer Institute

    Bristol, Somerset, BS2 8ED

  • University Hospital Coventry and Warwickshire Nhs Trust

    Coventry, West Midlands, CV2 2DX

  • Edinburgh Cancer Centre

    Edinburgh, Lothian, EH4 2XU

  • Royal Devon and Exeter Hospital NHS Trust

    Exeter, Devon, EX2 5DW

  • Saint Bartholomew's Hospital

    London, EC1A 7BE

  • University College London Hospitals

    London, NW1 2PG

  • The Christie

    Manchester, M20 4BX

  • The Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT

  • Taunton and Somerset NHS Foundation Trust

    Taunton, TA1 5DA

Other trials in United Kingdom

Romania8 sites

  • Institute of Oncology Bucharest

    Bucharest, Bucharest, 022328

  • Cardiomed

    Cluj-Napoca, Cluj, 400015

  • Institute of Oncology Prof. Dr Ion Chirircuta

    Cluj-Napoca, Cluj, 400015

  • Sfantul Nectarie Oncology Center

    Craiova, Dolj, 200347

  • Radiotherapy Center Cluj

    Floreşti, Cluj, 407280

  • Centrul De Oncologie Euroclinic

    Iași, 700106

  • Oncocenter Oncologie Clinica S.R.L

    Timișoara, Timiș County, 300166

  • Oncomed

    Timișoara, Timiș County, 300239

Other trials in Romania

Georgia7 sites

  • Cancer Center of Adjara

    Batumi, 6000

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

    Tbilisi, Caucasus, 0144

  • 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

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

    Tbilisi, 0159

  • TIM - Tbilisi Institute of Medicine

    Tbilisi, 0160

Other trials in Georgia

Mexico7 sites

  • Neurociencias Estudios Clinicos SC

    Culiacán, Sinaloa, 80020

  • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, Jalisco, 44280

  • Pan American Clinical Research

    Guadalajara, Jalisco, 44670

  • Preparaciones Oncologica SC

    León, Guanajuato, 37178

  • Centro De Atencion E Investigacion Clinica En Oncologia SCP

    Mérida, Yucatán, 97134

  • iCan Oncology

    Monterrey, Nuevo León, 64710

  • Faicic Centro de Investigacion Clinica de Veracruz

    Veracruz, 91910

Other trials in Mexico

Argentina6 sites

  • Fundacion Centro de Investigaciones para la Transformacion (CENIT)

    Caba, Buenos Aires, 1125

  • DIABAID - Instituto de Asistencia Integral en Diabetes

    Caba, 1061

  • Centro de Investigacion Pergamino

    Pergamino, Buenos Aires, B2700CPM

  • Instituto de Oncologia de Rosario

    Rosario, Santa Fe Province, S2000KZE

  • Centro Medico San Roque

    San Miguel de Tucumán, Tucumán Province, 4000

  • Clinica Viedma S.A.

    Viedma, Río Negro Province, 8500

Other trials in Argentina

Greece5 sites

  • National and Kapodistrian University of Athens

    Athens, Attica, 11527

  • Metropolitan Hospital

    Neo Faliro, Attica, 18547

  • Ongology Theageneio Thessaloniki

    Thessaloniki, 54007

  • BioClinic Thessaloniki

    Thessaloniki, 54622

  • Interbalkan Medical Center

    Thessaloniki, 57001

Other trials in Greece

Poland5 sites

  • UCK

    Gdansk, Pomeranian Voivodeship, 80-214

  • Copernicus Podmiot Leczniczy Sp. z o.o.Wojewodzie Centrum Onkologii

    Gdansk, Pomeranian Voivodeship, 80-219

  • 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 Słupsku Sp. z o.o.

    Słupsk, Pomeranian Voivodeship, 76-200

Other trials in Poland

Canada4 sites

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • 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

Ireland4 sites

  • Cork University Hospital

    Cork, T12 EC8P

  • Beaumont Hospital

    Dublin, D09 V2N0

  • St Vincents University Hospital

    Dublin, DO4YN63

  • Galway University Hospital

    Galway, Connacht, H91 YR71

Other trials in Ireland

South Africa4 sites

  • Groote Schuur Hospital

    Cape Town, Western Cape, 7925

  • The Medical Oncology Centre of Rosebank

    Johannesburg, Gauteng, 2196

  • Cape Town Oncology Trials

    Kraaifontein, Western Cape, 7570

  • Wilgers Oncology Centre

    Pretoria, Gauteng, 0081

Other trials in South Africa

Belgium3 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • AZ Groeninge

    Kortrijk, West-Vlaanderen, 8500

  • Vitaz campus Sint-Niklaas Moerland

    Sint-Niklaas, Oost-Vlaanderen, 9100

Other trials in Belgium

Chile3 sites

  • Clinica UC San Carlos de Apoquindo

    Santiago, Santiago Metropolitan, 7550000

  • Centro Oncologia de Precision Universidad Mayor

    Santiago, Santiago Metropolitan, 7560907

  • Oncocentro APYS

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Czechia3 sites

  • Masaryk Memorial Cancer Institute

    Brno, Brno Mesto, 65653

  • University Hospital Hradec Kralove

    Hradec Králové, North Central Czech Republic, 50005

  • University Hospital Ostrava

    Ostrava, 70852

Other trials in Czechia

Israel3 sites

  • Haemek Medical Center

    Afula, Northern District, 18340000

  • Hadassah Medical Organization

    Jerusalem, 91120

  • Sheba Medical Center

    Tel HaShomer, 5265601

Other trials in Israel

About this study

Official title: 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.

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 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.
Conditions
Melanoma
Being tested
Fianlimab, Cemiplimab, Pembrolizumab, Placebo
Keywords
Resected High Risk Melanoma, Skin Cancer, Stage IIB, Stage IIC, Stage III, Stage IV, LAG-3 Lymphocyte activation gene 3, Adjuvant Setting, anti-PD-1 Monoclonal Antibody
Medical subject headings
Melanoma, Skin Neoplasms

What participants receive

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

  • FianlimabDrug

    Also called REGN3767

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

  • CemiplimabDrug

    Also called REGN2810, Libtayo

    Cemiplimab will be administered by IV infusion Q 3 weeks

  • PembrolizumabDrug

    Also called MK-3475, lambrolizumab, Keytruda

    Pembrolizumab will be administered by IV infusion Q 3 weeks

  • PlaceboDrug

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

Study groups in NCT05608291
Study groupRoleWhat they receive
Fianlimab HD + CemiplimabExperimentalPatients will be administered one combination dose of fianlimab high dose (HD) and cemiplimab
Receives: Drug: Fianlimab; Drug: Cemiplimab
Fianlimab LD + CemiplimabExperimentalPatients will be administered one combination dose of fianlimab low dose (LD) and cemiplimab
Receives: Drug: Fianlimab; Drug: Cemiplimab
PembrolizumabActive comparatorPatients will be administered one dose of pembrolizumab co-infused with saline/dextrose placebo
Receives: Drug: Pembrolizumab; Drug: Placebo

What is being measured

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

  1. 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.

    Measured: Up to 5 Years

Secondary outcomes (22)

  1. Distant metastasis-free survival (DMFS)

    Time between the date of randomization and the date of the first distant metastasis.

    Measured: Up to 5 Years

  2. Overall survival (OS)

    Time from randomization to the date of death.

    Measured: Up to 5 Years

  3. 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.

    Measured: Up to 5 Years

  4. Occurrence of immune-mediated EAEs (im-EAEs)

    imAEs are a unique set of toxicities thought to be caused by unrestrained cellular immune responses.

    Measured: Up to 5 Years

  5. 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

    Measured: Up to 5 Years

  6. 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

    Measured: Up to 5 Years

  7. 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.

    Measured: Up to 5 Years

  8. 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.

    Measured: Up to 5 Years

  9. 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.

    Measured: Up to 5 Years

  10. Occurrence of laboratory abnormalities

    As assessed by the NCI-CTCAE grading system (≥ Grade 3 or higher)

    Measured: Up to 5 Years

  11. 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.

    Measured: Up to 5 Years

  12. 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.

    Measured: Up to 5 Years

  13. Concentration of finalimab anti-drug antibodies (ADA) and neutralizing antibodies

    Immunogenicity will be characterized per drug molecule by ADA and NAb status.

    Measured: Up to 5 Years

  14. Concentration of cemiplimab anti-drug antibodies (ADA) and neutralizing antibodies

    Immunogenicity will be characterized per drug molecule by ADA and NAb status.

    Measured: Up to 5 Years

  15. 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.

    Measured: Up to 5 Year

  16. 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.

    Measured: Up to 5 Years

  17. 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).

    Measured: Up to 5 Years

  18. 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".

    Measured: Up to 5 Years

  19. 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".

    Measured: Up to 5 Years

  20. Time to global health status/quality of life deterioration per EORTC QLQ-C30

    Measured: Up to 5 years

  21. Time to physical functioning deterioration per EORTC QLQ-C30

    Measured: Up to 5 Years

  22. Time to role functioning deterioration per EORTC QLQ-C30

    Measured: Up to 5 Years

Timeline

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

  1. First posted8 Nov 2022
  2. Study start16 Jan 2023
  3. Primary completion27 Jul 2026 (estimated)
  4. Study completion3 Apr 2030 (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
1,564 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05608291
Sponsor's protocol ID
R3767-ONC-2055
Other IDs
2022-501576-25-00
Status last verified
Jun 2026
First submitted
14 Oct 2022
Last updated
6 Jul 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.

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 211 sites in 22 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 3 inclusion and 8 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 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 211 sites in United States, Germany, France, Brazil, Spain and 17 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?

Relapse free survival (RSF) (time frame: Up to 5 Years). 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 NCT05608291.

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 6 Jul 2026.

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