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.
- Diseases
- Melanoma, Childhood cancers
- 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
Sites (100)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Algemeen Ziekenhuis Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Active, not recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Active, not recruiting |
| Verenigde Ziekenhuizen van Waas en Durme Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Active, not recruiting |
| Masaryk Memorial Cancer Institute Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Active, not recruiting |
| Fakultni Nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Novy Hradec Kralove | Czechia | Active, not recruiting |
| University Hospital Ostrava Coordinator of this site? Confirm its status | Ostrava-Poruba | Czechia | Active, not recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Katholisches Klinikum Bochum gGmbH Coordinator of this site? Confirm its status | Bochum | Germany | Recruiting |
| Gesundheit Nord gGmbH Klinikverbund Bremen Coordinator of this site? Confirm its status | Bremen | Germany | Recruiting |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| HELIOS Klinikum Erfurt GmbH Coordinator of this site? Confirm its status | Erfurt | Germany | Recruiting |
| Universitaetsklinikum Erlangen AöR Coordinator of this site? Confirm its status | Erlangen | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Universitaetsklinikum Frankfurt AöR Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Recruiting |
| Universitaetsmedizin Goettingen Coordinator of this site? Confirm its status | Goettingen | Germany | Recruiting |
| University Medical Centre Schleswig-Holstein Coordinator of this site? Confirm its status | Kiel | Germany | Recruiting |
| Klinikum der Stadt Ludwigshafen am Rhein gGmbH Coordinator of this site? Confirm its status | Ludwigshafen Am Rhein | Germany | Recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Luebeck | Germany | Recruiting |
| Universitätsklinikum Mannheim Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
| Fachklinik Hornheide e.V. Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| Universitaetsklinikum Muenster AöR Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| Klinikum Der Universitat Munchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Harzklinikum Dorothea Christiane Erxleben GmbH Coordinator of this site? Confirm its status | Quedlinburg | Germany | Recruiting |
| Universitaetsklinikum Regensburg Coordinator of this site? Confirm its status | Regensburg | Germany | Recruiting |
| HELIOS Kliniken Schwerin GmbH Coordinator of this site? Confirm its status | Schwerin | Germany | Recruiting |
| Universitaetsklinikum Tuebingen Coordinator of this site? Confirm its status | Tuebingen | Germany | Recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Instituto Oncologico Dr. Rosell S.L. Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Active, not recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Active, not recruiting |
| Hospital Universitario Lucus Augusti Coordinator of this site? Confirm its status | Lugo | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Clara Campal Comprehesive Cancer Center Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Active, not recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Active, not recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Fundación Instituto Valenciano de Oncología Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire Amiens - Picardie Coordinator of this site? Confirm its status | Amiens | France | Active, not recruiting |
| Institut Sainte-Catherine Coordinator of this site? Confirm its status | Avignon | France | Active, not recruiting |
| Besancon University Hospital Center Coordinator of this site? Confirm its status | Besancon Cedex | France | Active, not recruiting |
| Hopital Avicenne Coordinator of this site? Confirm its status | Bobigny Cedex | France | Active, not recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Active, not recruiting |
| Hôpital Ambroise-Paré Coordinator of this site? Confirm its status | Boulogne-Billancourt | France | Active, not recruiting |
| Centre Francois Baclesse Coordinator of this site? Confirm its status | Caen Cedex 5 | France | Active, not recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Active, not recruiting |
| Centr Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Active, not recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Active, not recruiting |
| Centre Hospitalier Le Mans Coordinator of this site? Confirm its status | Le Mans Cedex 9 | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Active, not recruiting |
| Hopital Saint Eloi Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Active, not recruiting |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| CHU De Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Active, not recruiting |
| Institut Claudius Regaud Coordinator of this site? Confirm its status | Toulouse | France | Active, not recruiting |
| Centre Hospitalier Valence Coordinator of this site? Confirm its status | Valence | France | Active, not recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Active, not recruiting |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| Metropolitan Hospital Coordinator of this site? Confirm its status | Pireas | Greece | Active, not recruiting |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| Genesis Idiotiki Geniki Maieftiki Gynaikologiki Kliniki S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| Theageneio Cancer Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| Cork University Hospital Coordinator of this site? Confirm its status | Cork | Ireland | Active, not recruiting |
| St Vincent's University Hospital Coordinator of this site? Confirm its status | Dublin 4 | Ireland | Active, not recruiting |
| Beaumont Hospital Coordinator of this site? Confirm its status | Dublin 9 | Ireland | Active, not recruiting |
| University Hospital Galway Coordinator of this site? Confirm its status | Galway | Ireland | Active, not recruiting |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona Coordinator of this site? Confirm its status | Ancona | Italy | Active, not recruiting |
| Istituto Tumori Bari Giovanni Paolo II Coordinator of this site? Confirm its status | Bari | Italy | Active, not recruiting |
| Azienda Ospedaliera Santa Croce E Carle Coordinator of this site? Confirm its status | Cuneo | Italy | Active, not recruiting |
| University Hospital Of Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Active, not recruiting |
| European Institute Of Oncology S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| University Hospital Of Perugia Coordinator of this site? Confirm its status | Perugia | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Fondazione Luigi Maria Monti Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Campus Bio-Medico Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Active, not recruiting |
| Azienda Provinciale Per I Servizi Sanitari Coordinator of this site? Confirm its status | Trento | Italy | Active, not recruiting |
| Azienda Sanitaria Universitaria Friuli Centrale Coordinator of this site? Confirm its status | Udine | Italy | Active, not recruiting |
| Copernicus Podmiot Leczniczy Sp. z o.o Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Coordinator of this site? Confirm its status | Siedlce | Poland | Recruiting |
| Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o. Coordinator of this site? Confirm its status | Slupsk | Poland | Recruiting |
| Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Active, not recruiting |
| Cardiomed SRL Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Active, not recruiting |
| Centrul De Oncologie SF Nectarie S.R.L. Coordinator of this site? Confirm its status | Craiova | Romania | Active, not recruiting |
| Radiotherapy Center Cluj S.R.L. Coordinator of this site? Confirm its status | Floresti | Romania | Active, not recruiting |
| Centrul De Oncologie-Euroclinic S.R.L. Coordinator of this site? Confirm its status | Jassi | Romania | Active, not recruiting |
| Oncomed S.R.L. Coordinator of this site? Confirm its status | Timisoara | Romania | Active, not recruiting |
| Oncocenter Oncologie Clinica S.R.L Coordinator of this site? Confirm its status | Timișoara | Romania | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.