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NCT05608291Active, not recruitingPhase 3

A trial to see if the combination of fianlimab with cemiplimab works better than pembrolizumab for preventing or delaying melanoma from coming back after it has been removed with surgery

A Phase 3 Trial of Fianlimab (anti-LAG-3) and Cemiplimab versus Pembrolizumab in the Adjuvant Setting in Patients with Completely Resected High-risk Melanoma

Source: EU CTIS (euclinicaltrials.eu) · Last updated 6 Jul 2026

Brief summary (registry, in English)

To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by relapse free survival (RFS)

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
798 (estimated)
First submitted
1 Feb 2023
Start date
7 Jul 2023
Lead sponsor
Regeneron Pharmaceuticals Inc.
NCT number
NCT05608291
EU CT number
2022-501576-25-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 798
  • 100 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Age

  • Adolescent patients (≥12 to <18 years old) with body weight <40 kg

Other

  • Uveal melanoma

Who the study is looking for

  • All patients must be either stage IIB, IIC, III, or stage IV per American Joint Committee on Cancer (AJCC) 8th edition according to cutaneous melanoma staging criteria 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

Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (100)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Algemeen Ziekenhuis Groeninge
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KortrijkBelgiumActive, not recruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumActive, not recruiting
Verenigde Ziekenhuizen van Waas en Durme
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Sint-NiklaasBelgiumActive, not recruiting
Masaryk Memorial Cancer Institute
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Brno-StredCzechiaActive, not recruiting
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaActive, not recruiting
University Hospital Ostrava
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Ostrava-PorubaCzechiaActive, not recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Katholisches Klinikum Bochum gGmbH
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BochumGermanyRecruiting
Gesundheit Nord gGmbH Klinikverbund Bremen
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BremenGermanyRecruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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DresdenGermanyRecruiting
HELIOS Klinikum Erfurt GmbH
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ErfurtGermanyRecruiting
Universitaetsklinikum Erlangen AöR
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ErlangenGermanyRecruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyRecruiting
Universitaetsklinikum Frankfurt AöR
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Frankfurt Am MainGermanyRecruiting
Universitaetsmedizin Goettingen
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GoettingenGermanyRecruiting
University Medical Centre Schleswig-Holstein
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KielGermanyRecruiting
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
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Ludwigshafen Am RheinGermanyRecruiting
Universitaetsklinikum Schleswig-Holstein AöR
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LuebeckGermanyRecruiting
Universitätsklinikum Mannheim
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MannheimGermanyRecruiting
Fachklinik Hornheide e.V.
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MuensterGermanyRecruiting
Universitaetsklinikum Muenster AöR
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MuensterGermanyRecruiting
Klinikum Der Universitat Munchen AöR
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MunichGermanyRecruiting
Harzklinikum Dorothea Christiane Erxleben GmbH
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QuedlinburgGermanyRecruiting
Universitaetsklinikum Regensburg
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RegensburgGermanyRecruiting
HELIOS Kliniken Schwerin GmbH
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SchwerinGermanyRecruiting
Universitaetsklinikum Tuebingen
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TuebingenGermanyRecruiting
Institut Catala d'Oncologia
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BadalonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Instituto Oncologico Dr. Rosell S.L.
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BarcelonaSpainActive, not recruiting
Hospital Universitario Virgen de las Nieves
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GranadaSpainActive, not recruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainActive, not recruiting
Hospital Universitario Lucus Augusti
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LugoSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario La Paz
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Clara Campal Comprehesive Cancer Center
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MadridSpainActive, not recruiting
Hospital Universitario Central De Asturias
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OviedoSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainActive, not recruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainActive, not recruiting
Fundación Instituto Valenciano de Oncología
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ValenciaSpainActive, not recruiting
Centre Hospitalier Universitaire Amiens - Picardie
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AmiensFranceActive, not recruiting
Institut Sainte-Catherine
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AvignonFranceActive, not recruiting
Besancon University Hospital Center
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Besancon CedexFranceActive, not recruiting
Hopital Avicenne
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Bobigny CedexFranceActive, not recruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceActive, not recruiting
Hôpital Ambroise-Paré
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Boulogne-BillancourtFranceActive, not recruiting
Centre Francois Baclesse
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Caen Cedex 5FranceActive, not recruiting
University Hospital Of Clermont-Ferrand
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Clermont-FerrandFranceActive, not recruiting
Assistance Publique Hopitaux De Paris
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Creteil CedexFranceActive, not recruiting
Centre Hospitalier Universitaire de Dijon
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DijonFranceActive, not recruiting
Centr Georges Francois Leclerc
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DijonFranceActive, not recruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceActive, not recruiting
Centre Hospitalier Le Mans
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Le Mans Cedex 9FranceActive, not recruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceActive, not recruiting
Hopital Saint Eloi
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Montpellier Cedex 5FranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceActive, not recruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceActive, not recruiting
Hopital Saint Louis
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ParisFranceActive, not recruiting
CHU De Rouen
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Rouen CedexFranceActive, not recruiting
Institut Claudius Regaud
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ToulouseFranceActive, not recruiting
Centre Hospitalier Valence
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ValenceFranceActive, not recruiting
Institut Gustave Roussy
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VillejuifFranceActive, not recruiting
Laiko General Hospital of Athens
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AthensGreeceActive, not recruiting
Metropolitan Hospital
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PireasGreeceActive, not recruiting
Athens Medical Center S.A.
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ThessalonikiGreeceActive, not recruiting
Genesis Idiotiki Geniki Maieftiki Gynaikologiki Kliniki S.A.
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ThessalonikiGreeceActive, not recruiting
Theageneio Cancer Hospital
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ThessalonikiGreeceActive, not recruiting
Cork University Hospital
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CorkIrelandActive, not recruiting
St Vincent's University Hospital
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Dublin 4IrelandActive, not recruiting
Beaumont Hospital
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Dublin 9IrelandActive, not recruiting
University Hospital Galway
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GalwayIrelandActive, not recruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona
Coordinator of this site? Confirm its status
AnconaItalyActive, not recruiting
Istituto Tumori Bari Giovanni Paolo II
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BariItalyActive, not recruiting
Azienda Ospedaliera Santa Croce E Carle
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CuneoItalyActive, not recruiting
University Hospital Of Ferrara
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FerraraItalyActive, not recruiting
European Institute Of Oncology S.r.l.
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MilanItalyActive, not recruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyActive, not recruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyActive, not recruiting
University Hospital Of Perugia
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PerugiaItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyActive, not recruiting
Fondazione Luigi Maria Monti
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RomeItalyActive, not recruiting
Fondazione Policlinico Universitario Campus Bio-Medico
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RomeItalyActive, not recruiting
Humanitas Research Hospital
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RozzanoItalyActive, not recruiting
Azienda Provinciale Per I Servizi Sanitari
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TrentoItalyActive, not recruiting
Azienda Sanitaria Universitaria Friuli Centrale
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UdineItalyActive, not recruiting
Copernicus Podmiot Leczniczy Sp. z o.o
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GdanskPolandRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandRecruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandRecruiting
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Coordinator of this site? Confirm its status
SiedlcePolandRecruiting
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Coordinator of this site? Confirm its status
SlupskPolandRecruiting
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Coordinator of this site? Confirm its status
BucharestRomaniaActive, not recruiting
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Coordinator of this site? Confirm its status
Cluj-NapocaRomaniaActive, not recruiting
Cardiomed SRL
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Cluj-NapocaRomaniaActive, not recruiting
Centrul De Oncologie SF Nectarie S.R.L.
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CraiovaRomaniaActive, not recruiting
Radiotherapy Center Cluj S.R.L.
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FlorestiRomaniaActive, not recruiting
Centrul De Oncologie-Euroclinic S.R.L.
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JassiRomaniaActive, not recruiting
Oncomed S.R.L.
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TimisoaraRomaniaActive, not recruiting
Oncocenter Oncologie Clinica S.R.L
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TimișoaraRomaniaActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.