New immunotherapy duo aims to stop melanoma recurrence

NCT ID NCT05608291

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether combining two immunotherapy drugs—fianlimab and cemiplimab—can better prevent melanoma from coming back after surgical removal, compared to the standard drug pembrolizumab. The study enrolls people with high-risk melanoma (stages IIB–IV) who have had all visible cancer removed. Participants receive either the combination or pembrolizumab every three weeks, and researchers track how long they remain cancer-free.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
fianlimab and cemiplimab (combination immunotherapy)
What this could lead to
If successful, this combination could offer a new option to reduce the risk of melanoma returning after surgery, potentially improving relapse-free survival.
What could go wrong
This is an early-stage comparison against an already approved drug, so the new combination may not prove superior. Side effects from immunotherapy can be serious, including immune-related inflammation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AZ Groeninge

    Kortrijk, West-Vlaanderen, 8500, Belgium

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

    Tbilisi, 0112, Georgia

  • Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • Andrew Love Cancer Centre

    Geelong, Victoria, 3220, Australia

  • Animi Unidade de Tratamento Oncologico

    Lages, Santa Catarina, 88501-001, Brazil

  • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, Jalisco, 44280, Mexico

  • Azienda Ospedaliera Santa Croce i Carle

    Cuneo, 12100, Italy

  • Azienda Sanitaria Universitaria del Friuli Centrale

    Udine, 33100, Italy

  • Baskent University

    Yüreğir, Adana, 01230, Turkey (Türkiye)

  • Beaumont Hospital

    Dublin, D09 V2N0, Ireland

  • Besancon Regional University Hospital Center

    Besançon, Doubs, 25000, France

  • BioClinic Thessaloniki

    Thessaloniki, 54622, Greece

  • Blacktown Cancer and Haematology Centre - Blacktown Hospital

    Blacktown, New South Wales, 2148, Australia

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

    Bristol, Somerset, BS2 8ED, United Kingdom

  • CHU Amiens-Picardie

    Amiens, Picardie, 80000, France

  • CHU Estaing

    Clermont-Ferrand, 63003, France

  • CHU de Lille

    Lille, Hauts-de-France, 59000, France

  • CHU-Dijon

    Dijon, Burgundy, 21000, France

  • Calvary North Adelaide Hospital

    North Adelaide, South Australia, 5006, Australia

  • Campus Bio-Medico di Roma

    Rome, 00128, Italy

  • Cancer Center of Adjara

    Batumi, 6000, Georgia

  • Cape Town Oncology Trials

    Kraaifontein, Western Cape, 7570, South Africa

  • Cardiomed

    Cluj-Napoca, Cluj, 400015, Romania

  • Catalan Institute of Oncology (ICO) Hospitalet

    Barcelona, 08908, Spain

  • Catarina Pesquisa Clinica

    Itajaí, Santa Catarina, 88301-220, Brazil

  • Centre Francois Baclesse (CFB)

    Caen, Normandy, 14076, France

  • Centre Georges Francois Leclerc

    Dijon, Bourgogne-Franche-Comté, 21000, France

  • Centre Hospitalier Le Mans

    Le Mans, Pays de la Loire Region, 72037, France

  • Centre Hospitalier Universitaire De Nice Hopital De L Archet

    Nice, 06202, France

  • Centre Hospitalier Universitaire Grenoble Alpes

    La Tronche, Isere, 38700, France

  • Centre Hospitalier de Valence

    Valence, 26000, France

  • Centro De Atencion E Investigacion Clinica En Oncologia SCP

    Mérida, Yucatán, 97134, Mexico

  • Centro Integral Oncologico HM Clara Campal

    Madrid, 28050, Spain

  • Centro Medico San Roque

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Centro Oncologia de Precision Universidad Mayor

    Santiago, Santiago Metropolitan, 7560907, Chile

  • Centro de Investigacion Pergamino

    Pergamino, Buenos Aires, B2700CPM, Argentina

  • Centro de Pesquisa em Oncologia PUCRS

    Porto Alegre, Rio Grande do Sul, 90619900, Brazil

  • Centrul De Oncologie Euroclinic

    Iași, 700106, Romania

  • Charite Universitaetsmedizin Berlin

    Berlin, 10117, Germany

  • Chu De Bordeaux

    Bordeaux, Gironde, 33075, France

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Clinica Oncologica, AOU Riuniti Ancona

    Ancona, An, 60020, Italy

  • Clinica UC San Carlos de Apoquindo

    Santiago, Santiago Metropolitan, 7550000, Chile

  • Clinica Viedma S.A.

    Viedma, Río Negro Province, 8500, Argentina

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Columbia University

    New York, New York, 10032, United States

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

    Gdansk, Pomeranian Voivodeship, 80-219, Poland

  • Cork University Hospital

    Cork, T12 EC8P, Ireland

  • DIABAID - Instituto de Asistencia Integral en Diabetes

    Caba, 1061, Argentina

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dermatology Erlangen

    Erlangen, Bavaria, 91054, Germany

  • Dicle University - Medical Faculty Campus

    Sur, Diyarbakır, 21200, Turkey (Türkiye)

  • Dr. Everett Chalmers Hospital

    Fredericton, New Brunswick, E3B 5N5, Canada

  • Duke Cancer Institute, University Hospital

    Durham, North Carolina, 27710, United States

  • Eastern Health

    Box Hill, Victoria, 3128, Australia

  • Edinburgh Cancer Centre

    Edinburgh, Lothian, EH4 2XU, United Kingdom

  • Fachklinik Hornheide

    Münster, North Rhine-Westphalia, 48157, Germany

  • Faicic Centro de Investigacion Clinica de Veracruz

    Veracruz, 91910, Mexico

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • Fondazione Policlinico Universitrio a. Gemelli - IRCCS

    Rome, 000168, Italy

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

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

  • Fundacao Pio XII - Hospital de Amor

    Barretos, São Paulo, 14784400, Brazil

  • Fundacion Centro de Investigaciones para la Transformacion (CENIT)

    Caba, Buenos Aires, 1125, Argentina

  • Galway University Hospital

    Galway, Connacht, H91 YR71, Ireland

  • Gaziantep Medicalpoint Hospital

    Gaziantep, Sehitkamil, 27584, Turkey (Türkiye)

  • Groote Schuur Hospital

    Cape Town, Western Cape, 7925, South Africa

  • Gulhane Research And Training Hospital

    Ankara, 06010, Turkey (Türkiye)

  • H. Germans Trias i Pujol, ICO-Badalona

    Badalona, Barcelona, 08916, Spain

  • Hadassah Medical Organization

    Jerusalem, 91120, Israel

  • Haemek Medical Center

    Afula, Northern District, 18340000, Israel

  • Hautklinik

    Ludwigshafen am Rhein, Rhineland-Palatinate, D-67063, Germany

  • Helios Kliniken Schwerin

    Schwerin, Mecklenburg-Vorpommern, 19055, Germany

  • Helios Klinikum Erfurt

    Erfurt, Thuringia, D-99089, Germany

  • Hemomed

    São Paulo, 01236030, Brazil

  • Hopital Avicenne

    Bobigny, Île-de-France Region, 93000, France

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Henri Mondor

    Créteil, Île-de-France Region, 94000, France

  • Hospital Moinhos de vento

    Porto Alegre, Rio Grande do Sul, 90440140, Brazil

  • Hospital Sirio Libanes

    São Paulo, 01308-050, Brazil

  • Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM

    Madrid, 28041, Spain

  • Hospital Universitario Central De Asturias

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario La Pa<

    Madrid, 28046, Spain

  • Hospital Universitario Lucus Augusti

    Lugo, 27003, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014, Spain

  • Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital das Clinicas da Universidade Federal de Minas Gerais

    Belo Horizonte, Minas Gerais, 30130-090, Brazil

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035007, Brazil

  • INCA Instituto Nacional de Cancer

    Santo Cristo, Rio de Janeiro, 20220-410, Brazil

  • Incliva - Instituto de Investigacion Sanitaria

    Valencia, 46010, Spain

  • Institut Claudius Regaud, IUCT-Oncopole

    Toulouse, Haute-Garonne, 31059, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Institute of Oncology Bucharest

    Bucharest, Bucharest, 022328, Romania

  • Institute of Oncology Prof. Dr Ion Chirircuta

    Cluj-Napoca, Cluj, 400015, Romania

  • Instituto COI

    Rio de Janeiro, 23793-080, Brazil

  • Instituto Joinvilense de Hematologia e Oncologia

    Joinville, Santa Catarina, 89201260, Brazil

  • Instituto Nazionale Tumori Fondazione Giovanni Pascale

    Naples, 80131, Italy

  • Instituto Oncologico Dr Rosell Hospital Universitari Quiron Dexeus Location

    Barcelona, Catalonia, 08028, Spain

  • Instituto Valenciano de Oncologia

    Valencia, 46009, Spain

  • Instituto de Oncologia de Rosario

    Rosario, Santa Fe Province, S2000KZE, Argentina

  • Instituto do Cancer em Hospital Sao Vicente de Paulo

    Passo Fundo, Rio Grande do Sul, 99010-090, Brazil

  • Interbalkan Medical Center

    Thessaloniki, 57001, Greece

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Israeli Georgian Medical Research Clinic Helsicore

    Tbilisi, 0112, Georgia

  • Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital

    Istanbul, 81450, Turkey (Türkiye)

  • Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty

    Istanbul, 34450, Turkey (Türkiye)

  • Istituto Clinico Humanitas

    Milan, Lombardy, 20089, Italy

  • Istituto Dermopatico dell'Immacolata

    Rome, 00167, Italy

  • Istituto Europeo di Oncologia

    Milan, 20141, Italy

  • Istituto Romagnolo per lo Studio dei Tumori (IRST)

    Meldola, Forli Cesena, 47014, Italy

  • Istituto dei Tumori

    Bari, 70124, Italy

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

    Tbilisi, 0159, Georgia

  • John Wayne Cancer Institute (JWCI)

    Santa Monica, California, 90404, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Klinikum Bremen Ost

    Bremen, 28325, Germany

  • Klinikum Darmstadt GmbH

    Darmstadt, Hesse, 64283, Germany

  • Kocaeli University

    İzmit, Kocaeli, 41380, Turkey (Türkiye)

  • LMU Klinikum

    Munich, Bavaria, 80337, Germany

  • LTD New Hospitals

    Tbilisi, 0114, Georgia

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016, United States

  • Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060, Brazil

  • Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599, United States

  • Lismore Base Hospital

    Lismore, New South Wales, 2480, Australia

  • Liverpool Hospital - Cancer Therapy Centre

    Liverpool, New South Wales, 2170, Australia

  • Masaryk Memorial Cancer Institute

    Brno, Brno Mesto, 65653, Czechia

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii

    Siedlce, Mazxowieckie, 08-110, Poland

  • Melanoma Institute of Australia

    Wollstonecraft, New South Wales, 2065, Australia

  • Memorial Ankara Hospital

    Ankara, 0906520, Turkey (Türkiye)

  • Metropolitan Hospital

    Neo Faliro, Attica, 18547, Greece

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida, 33176, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • N_Hôpital Ambroise-Paré

    Boulogne-Billancourt, 92100, France

  • Nantes University Hospital

    Nantes, Pays de la Loire Region, 44093, France

  • National and Kapodistrian University of Athens

    Athens, Attica, 11527, Greece

  • Neurociencias Estudios Clinicos SC

    Culiacán, Sinaloa, 80020, Mexico

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Oncocenter Oncologie Clinica S.R.L

    Timișoara, Timiș County, 300166, Romania

  • Oncocentro APYS

    Viña del Mar, Valparaiso, 2520598, Chile

  • Oncomed

    Timișoara, Timiș County, 300239, Romania

  • Oncosite Centro De Pesquisa Em Oncologia

    Ijuí, Rio Grande do Sul, 98700-000, Brazil

  • One Clinical Research at Hollywood Private Hospital

    Nedlands, Western Australia, 6009, Australia

  • Ongology Theageneio Thessaloniki

    Thessaloniki, 54007, Greece

  • Orlando Health

    Orlando, Florida, 32806, United States

  • Ozel Liv Hospital

    Ankara, 06100, Turkey (Türkiye)

  • Pan American Clinical Research

    Guadalajara, Jalisco, 44670, Mexico

  • Poznan University of Meidcla Science

    Poznan, Wielkopolska, 60-788, Poland

  • Preparaciones Oncologica SC

    León, Guanajuato, 37178, Mexico

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Radiotherapy Center Cluj

    Floreşti, Cluj, 407280, Romania

  • Royal Devon and Exeter Hospital NHS Trust

    Exeter, Devon, EX2 5DW, United Kingdom

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2, Canada

  • Ruhr University Bochum

    Bochum, North Rhine-Westphalia, 44791, Germany

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901, United States

  • Saint Bartholomew's Hospital

    London, EC1A 7BE, United Kingdom

  • Saint Louis Hospital

    Paris, Île-de-France Region, 75010, France

  • Sainte Catherine Institut du Cancer Avignon Provence

    Avignon, 84918, France

  • Santa Chiara Hospital

    Trento, 38122, Italy

  • Sao Camilo Oncologia

    São Paulo, 04014-002, Brazil

  • Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam

    Ankara, 06100, Turkey (Türkiye)

  • Service de Dermatologie CHU Saint Eloi

    Montpellier, Herault, 34295, France

  • Sfantul Nectarie Oncology Center

    Craiova, Dolj, 200347, Romania

  • Sheba Medical Center

    Tel Litwinsky, 5265601, Israel

  • Skin Cancer Center Harz

    Quedlinburg, Saxony-Anhalt, 06484, Germany

  • St Lukes University Health Network

    Easton, Pennsylvania, 18045, United States

  • St Vincents University Hospital

    Dublin, DO4YN63, Ireland

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • TIM - Tbilisi Institute of Medicine

    Tbilisi, 0160, Georgia

  • Taunton and Somerset NHS Foundation Trust

    Taunton, TA1 5DA, United Kingdom

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

    Tbilisi, Caucasus, 0144, Georgia

  • Tennessee Oncology - Centennial Clinic Location

    Nashville, Tennessee, 37203-1625, United States

  • The Christie

    Manchester, M20 4BX, United Kingdom

  • The Medical Oncology Centre of Rosebank

    Johannesburg, Gauteng, 2196, South Africa

  • The Melanoma And Skin Cancer Institute

    Englewood, Colorado, 80113, United States

  • The Ohio State University James Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • The Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Trakya University

    Edirne, 22030, Turkey (Türkiye)

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

    Naples, Campania, 80121, Italy

  • UC San Diego

    La Jolla, California, 92093, United States

  • UCK

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • UCSF Medical Center at Mission Bay

    San Francisco, California, 94158, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Unimed Sorocaba

    Sorocaba, São Paulo, 18052-210, Brazil

  • Universitatsklinikum Essen

    Essen, North Rhine-Westphalia, 45147, Germany

  • Universitatsklinikum Schleswig Holstein Campus Luebeck

    Lübeck, Schleswig-Holstein, 23538, Germany

  • University Clinic Frankfurt

    Frankfurt am Main, Hesse, 60590, Germany

  • University College London Hospitals

    London, NW1 2PG, United Kingdom

  • University Hospital Augsburg

    Augsburg, Bavaria, 86179, Germany

  • University Hospital Coventry and Warwickshire Nhs Trust

    Coventry, West Midlands, CV2 2DX, United Kingdom

  • University Hospital Dresden

    Dresden, Saxony, 01307, Germany

  • University Hospital Hradec Kralove

    Hradec Králové, North Central Czech Republic, 50005, Czechia

  • University Hospital Muenster

    Münster, North Rhine-Westphalia, 48149, Germany

  • University Hospital Ostrava

    Ostrava, 70852, Czechia

  • University Hospital of Regensburg

    Regensburg, Bavaria, 93053, Germany

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

    Kiel, Schleswig-Holstein, 24105, Germany

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University Medical Center Goettingen

    Göttingen, Lower Saxony, 37075, Germany

  • University Medical Center Mannheim

    Mannheim, Baden-Wurttemberg, 68167, Germany

  • University Of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Perugia

    Perugia, 06132, Italy

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920, United States

  • University of Tuebingen

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22903, United States

  • Verdi Oncology

    Nashville, Tennessee, 37203, United States

  • Vitaz campus Sint-Niklaas Moerland

    Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

  • Wilgers Oncology Centre

    Pretoria, Gauteng, 0081, South Africa

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

    Słupsk, Pomeranian Voivodeship, 76-200, Poland

  • iCan Oncology

    Monterrey, Nuevo León, 64710, Mexico

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