Melanoma Clinical Trial

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

Summary

The primary objective of the study is To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by relapse free survival (RFS)

The secondary objectives of the study are:

To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by overall survival (OS)
To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by melanoma specific survival (MSS)
To evaluate whether post-operative adjuvant therapy improves distant metastasis-free survival (DMFS), in stage IIC or III patients receiving fianlimab + cemiplimab compared to pembrolizumab
To assess impact of fianlimab + cemiplimab on quality of life as compared to pembrolizumab in adults
To assess safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab
To characterize pharmacokinetics (PK) of fianlimab + cemiplimab using sparse PK sampling in patients 12 years of age and older
To assess immunogenicity of fianlimab and against cemiplimab

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

1530

Study ID:

NCT05608291

Recruitment Status:

Recruiting

Sponsor:

Regeneron Pharmaceuticals

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There are 186 Locations for this study

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University of California San Diego
La Jolla California, 92093, United States
University of California, San Francisco
San Francisco California, 94158, United States
John Wayne Cancer Institute - Saint John's Health Center
Santa Monica California, 90404, United States
The Melanoma And Skin Cancer Institute
Englewood Colorado, 80113, United States
Miami Cancer Institute
Miami Florida, 33176, United States
Orlando Health Cancer Institute
Orlando Florida, 32806, United States
Northwestern Medical Group
Chicago Illinois, 60611, United States
Massachusetts General Cancer Center
Boston Massachusetts, 02114, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
NYU Langone Health
New York New York, 10016, United States
Columbia University Medical Center
New York New York, 10032, United States
University of Rochester
Rochester New York, 14642, United States
Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
St. Luke's Hematology
Easton Pennsylvania, 18045, United States
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
University of Tennessee Medical Center
Knoxville Tennessee, 37920, United States
SCRI Partners - Verdi Oncology
Nashville Tennessee, 37203, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States
The University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Intermountain Medical Center
Murray Utah, 84107, United States
University of Virginia Health System
Charlottesville Virginia, 22908, United States
Virginia Cancer Specialist Research Institute
Fairfax Virginia, 22031, United States
Fundacion CENIT para la investigacion en Neurociencias
Ciudad Autonoma Buenos Aires, C1125, Argentina
DIABAID - Instituto de Asistencia Integral en Diabetes
Ciudad Autonoma Buenos Aires, , Argentina
Clinica Viedma S.A.
Viedma Rio Negro, 8500, Argentina
Instituto de Oncologia de Rosario - Departamento de Investigaciones
Rosario Santa Fe, S2000, Argentina
Centro Medico San Roque
San Miguel de Tucumán Tacuman Province, 4000, Argentina
Liverpool Hospital (Cancer Therapy Pharmacy)
Liverpool New South Wales, 2170, Australia
Calvary North Adelaid Hospital (HPS Pharmacies)
Adelaide South Australia, 5006, Australia
Flinders Medical Centre
Bedford Park South Australia, 5042, Australia
Box Hill Hospital
Box Hill Victoria, 3128, Australia
Andrew Love Cancer Centre, University Hospital Geelong
Geelong Victoria, 3220, Australia
Alfred Health
Melbourne Victoria, 3004, Australia
One Clinical Research
Nedlands Western Australia, 6009, Australia
VITAZ vzw - pharm Sara Van Opdenbosch t.a.v. apotheek
Sint Niklaas East Flanders, 9100, Belgium
Cliniques Universitaires Saint-Luc
Brussels Region De Bruxelles, 1200, Belgium
Campus Kennedylaan Apotheek
Kortrijk West-Vlaaderen, 8500, Belgium
Centro Avancado de Tratamento Oncologico (CENANTRON)
Belo Horizonte Minas Geraise, 30130, Brazil
Hospital Erasto Gaertner
Curitiba Parana, 81520, Brazil
Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca (COI Clinicas Oncologicas Integradas SA)
Barra da Tijuca Rio De Janeiro, 2279-, Brazil
INCA - Brazilian National Cancer Institute
Santo Cristo Rio De Janeiro, 20220, Brazil
ONCOSITE - CENTRO DE PESQUISA CLINICA EM ONCOLOGIA LTDA Setor Farmacia Pesquisa Clini
Ijui Rio Grande Do Sul, 98700, Brazil
Hospital Sao Vicente de Paulo - Instituto do Cancer
Passo Fundo Rio Grande Do Sul, 99010, Brazil
Associacao Hospitalar Moinhos de Vento, Centro de Pesquisa Clinica
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Hospital de Clinicas de Porto Alegre - UPCO- pesquisa Clinica em Oncologia do HCPA
Porto Alegre Rio Grande Do Sul, 90035, Brazil
CPO - Centro de Pesquisas em Oncologia
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Clinica de Neoplasias Litoral
Itajai Santa Catarina, 88301, Brazil
Instituto Joinvilense de Hematologia e Oncologia
Joinville Santa Catarina, 89201, Brazil
Animi Unidade de Tratamento Oncologico Ltda
Lages Santa Catarina, 88501, Brazil
Instituto de Ensino e Pesquisas Sao Lucas - IEP HEMOMED
Sao Paulo Sao Paulo Estado, 01236, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos Sao Paulo, 14784, Brazil
Hospital Sirio-Libanes
Sao Paulo , 01308, Brazil
Nucleo de Pesquisa da Rede Sao Camilo (Instituto Brasileiro de Controle do Cancer)
Sao Paulo , 14784, Brazil
Dr. Everett Chalmers Hospital
Fredericton New Brunswick, E3B5N, Canada
Royal Victoria Regional Health Centre
Barrie Ontario, L4M 6, Canada
Sunnybrook Research Institute
Toronto Ontario, M4N 3, Canada
University Health Network, Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Universidad Mayor - Centro Oncologia de Precision (PROFAR)
Santiago Metropolitana De Santiago, 75609, Chile
Clinica UC San Carlos de Apoquindo
Santiago Metropolitana De Santiago, 76200, Chile
Oncovida
Santiago Santiago Region Metropolitana De Santiago, 75100, Chile
Oncocentro APYS
Valparaiso , 25205, Chile
University Hospital Hradec Kralove
Hradec Kralove Bohemia, 50005, Czechia
University Hospital Ostrava Pharmacy
Ostrava Moravia Region, 70852, Czechia
Masaryk Memorial Cancer Institute, Hospital Pharmacy
Brno South Moravian, 65653, Czechia
CHU de DIJON - Pharmacie Essais Cliniques
Dijon Bourgogne-Franche-Comte, 21000, France
Centre Georges Francois Leclerc
Dijon Bourgogne-Franche-Comté, 21079, France
CHU Jean Minjoz
Besancon Cedex Bourgogne, 25030, France
CHU Grenoble Alpes
La Tronche Grenoble, 38700, France
Institut Claudius Regaud - Pharmacie
Toulouse Haute-Garonne, 31059, France
Gustave Roussy - Pharmacie Essais Cliniques -1
Vaillant Ile De France, 94805, France
Hopital Saint Louis - APHP, Service de Pharmacie - Niveau
Paris Ile-de-France, 75010, France
CHU Lille, Pharmacie Centrale
Lille Nord Deparment, 59037, France
Centre Francois Baclesse
Caen Normandy, 14076, France
Hopital Saint Andre, Pharmacie
Bordeaux Nouvelle-Aquitaine, 33075, France
Unite de Pharmacie Clinique Oncologique (UPCO)
Montpellier Occitanie Region, 34090, France
Hopital Ambroise Pare
Boulogne Billancourt Paris, 92100, France
CHU HENRI MONDOR Pharmacie Secteur ESSAIS CLINIQUES
Creteil Paris, 94000, France
CHU de NANTES Hotel Dieu
Nantes Pays De La Loire Région, 44000, France
Sainte Catherine Institut du Cancer Avignon Provence
Avignon Province Alpes Cote d'Azur, 84918, France
CHU G. Montpied, Pharmacie, secteur recherche clinique
Clermont-Ferrand Puy-de-Dôme, 63003, France
CH Le Mans - CCS Pharmacie-essais cliniques, aile B
Le Mans Sarthe, 72037, France
Hopital Avicenne Service Pharmacie Secteur essais cliniques
Bobigny Seine Saint Denis, 93000, France
CHU Amiens-Picardie Site Sud
Amiens Somme, 80054, France
Centre Hospitalier Universitaire de Nice,Hopital l Archet
Nice , 06200, France
CHU Charles Nicolle
Rouen , 76031, France
LTD Cancer Center of Adjara Autonomic Republic
Batumi Adjara, 6000, Georgia
Israeli Georgian medical research clinic Helsicore
T'bilisi South Caucasus, 0112, Georgia
LTD Research Institute of Clinical Medicine (LLC Todua Clinic)
T'bilisi South Caucasus, 0112, Georgia
LTD New Hospitals
T'bilisi South Caucasus, 0114, Georgia
High Technology Medical Center, University Clinic Tbilisi
T'bilisi South Caucasus, 0144, Georgia
Tbilisi Institute of Medicine (TIM)
T'bilisi South Caucasus, 0168, Georgia
JSC K. Eristavi National Center of Experimental and Clinical Surgery
Tbilisi South Caucasus, 0159, Georgia
University Medical Center Mannheim
Mannheim Baden-Wurttemberg, 68167, Germany
University Hospital Tuebingen
Tubingen Baden-Wurttemberg, 72076, Germany
Hautklinik Universitatsklinikum Erlangen
Erlangen Bavaria, 91054, Germany
LMU Klinikum Munchen, Pharmacy
Munchen Bavaria, 80337, Germany
Klinikum Darmstadt GmbH
Darmstadt Hessen, 64283, Germany
Universitatsmedizin Gottingen
Gottingen Lower Saxony, 37075, Germany
Helios Kliniken Schwerin GmbH, Apotheke
Schwerin Mecklenburg Vorpommern, 19055, Germany
Universitaetstklinikum Muenster Central Study Coordination for innovative Dermatology (ZID)
Muenster North Rhine-Westphalia, 48149, Germany
Hohenzollernapotheke
Muenster North Rhine-Westphalia, 48157, Germany
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen Rhindeland Palatinate, 67063, Germany
Harzklinikum Dorothea Christiane Erxleben GmbH, Zentrale Krankenhausapotheke
Quedlinburg Sachsen-Anhalt, 06484, Germany
Universitatsklinikum Carl Gustav Carus Dresden, Klinik Apotheke - building 60
Dresden Saxony, 01307, Germany
UKSH-Campus Kiel
Kiel Schleswig-Holstein, 24105, Germany
Campus Virchow Klinikum, Apotheke Zytostatika Studien, Charite - Universitatsmedizin Berlin,
Berlin , 10117, Germany
Katholisches Klinikum Bochum -Zentral Apotheke
Bochum , 44791, Germany
Klinikum Bremen-Ost - Studienambulanz Dermatologie
Bremen , 28325, Germany
Helios Klinikum Erfurt
Erfurt , 99089, Germany
Universitaetsklinikum Essen, Apotheke
Essen , 45147, Germany
Universitatsklinikum Regensburg Studienburo Dermatologie
Regensburg , 93053, Germany
A Oncology Dpt, Laiko General Hospital of Athens
Goudi Athens, 11527, Greece
A Oncology Dpt, Metropolitan Hospital
Athens Pireas, 18547, Greece
Bioclinic of Thessaloniki
Thessaloniki Pylaia, 54622, Greece
Iatriko Diavalkaniko Thessaloniki, Pharmacy
Thessaloniki Pylaia, 57001, Greece
Theagenio Cancer Center
Efkarpia Thessalonili, 56403, Greece
University Hospital Galway
Galway Connacht, H91 Y, Ireland
Beaumont Hospital
Beaumont Dublin, D09V2, Ireland
University College Cork-Cork University Maternity Hospital
Cork Munster, , Ireland
St Vincent's University Hospital
Dublin , D04 T, Ireland
Haemek Medical Center
Afula Northern District, 18341, Israel
The Chaim Sheba Medical Center
Ramat-Gan Tel Aviv, 52621, Israel
Hadassah Ein Kerem Medical Center
Jerusalem , 91120, Israel
UOC del Farmaco - PO San Salvatore
L'Aquila Abruzzo, 67100, Italy
Universita della Campania Luigi Vanvitella
Napoli Campania, 80121, Italy
Instituto Nazionale Tumori IRCCS Fondazione G. Pascale
Napoli Campania, 80131, Italy
Clinica Malattie Infettive, Azienda Ospedaliero Universitaria
Udine Friuli-Venezia Giulia, 33100, Italy
Fondazione Policlinico Campus Bio-Medico
Rome Lazio, 00128, Italy
Farmacia Ospedaliera, Fondazione Policlinico Universitario Agostini Gemeli IRCCS
Rome Lazio, 00168, Italy
Farmacia Ospedaliera, Instituto Europeo di Oncologia
Milan Lombardy, 20141, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Tumori Giovanni Paolo II - Ospedale Oncologico di Bari
Bari Metropolitan City Of Bari, 70124, Italy
AO S.Croce E Carle
Cuneo Piedmont, 12100, Italy
Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss)
Roma Rome Province, 00167, Italy
AO perugia SC Oncologia
Perugia Umbria, 06132, Italy
Arcispedale SantAnna UOC Farmacia Ospedaliera Ufficio sperimentazioni cliniche, SETTORE 2B1 Presidi
Cona Veneto, 44124, Italy
Azienda Ospedaliero Universitaria Maggiore della Carita, Farmacia Ospedaliera
Novara , 28100, Italy
UOC Oncologia Medica
Taormina , 98039, Italy
Farmacia Ospedaliera - Azienda Ospedaliero Universitaria delle Marche
Torrette , 60126, Italy
Ospedale S.Chiara - APSS di Trento - Magazzino Farmacia
Trento , 38123, Italy
Preparaciones Oncologicas S. C.
Leon Guanajuato Guanajuato, 37178, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara Jalisco, 44280, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos S.A de C.V
Zapopan Jalisco, 45070, Mexico
iCan Oncology Center S.A de C.V.
Monterrey Nuevo Leon, 64710, Mexico
Neurociencias Estudios Clinicos S. C.
Culiacan Sinaloa, 80020, Mexico
FAICIC S. de R.L. de C.V.
Veracruz Veracruz Estado, 91900, Mexico
Centro de Atencion e Investigacion Clinica en Oncologia
Merida Yucatan, 97134, Mexico
Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii
Siedlce Mazowieckie, 08-11, Poland
Uniwersyteckie Centrum Kliniczne (UCK)
Gdansk Pomeria, 80-21, Poland
Wojewodzki Szpital Specjalistyczny im. J. Korczaka w Slupsku
Slupsk Pomorskie, 16-20, Poland
Centrul de Oncologie Sf. Nectarie S.R.L/SC
Craiova Dolj, 20054, Romania
Radiotheraoy Center Cluj/Ph
Cluj Floresti, 40728, Romania
Centrul De Oncologie Euroclinic
Iași Moldava, 70010, Romania
Oncocenter-Oncologie Clinica SRL
Timisoara Timis, 30021, Romania
Oncomed
Timisoara Timis, 30023, Romania
Cardiomed
Cluj Napoca Transylvania, 40001, Romania
Institul Oncologic Prof. Dr Ion Chiricuta
Cluj Napoca Transylvania, 40001, Romania
Institute of Oncology Bucharest
Bucharest , 02232, Romania
The Medical Oncology Centre of Rosebank
Johannesburg Gauteng, 2196, South Africa
Wilgers Oncology Center
Pretoria Gauteng, 7570, South Africa
Cape Gate Oncology Trials
Cape Town Western Cape, 7570, South Africa
Hospital Universitario Virgen Macarena
Sevilla Andalucia, 41009, Spain
Hospital Universitario Central de Asturias
Oviedo Asturias, 33011, Spain
Hospital Universitario Marques De Valdecilla
Santander Cantabria, 39008, Spain
Hospital Universitario Quiron Dexeus Barcelona
Barcelona Catalonia, 08028, Spain
Area dassajos clinics/Medicaments en investigacio, Servei de Farmacia Hospital Clinic de Barcelona (ICMHO)
Barcelona Catalonia, 08035, Spain
Hospital Universitario Vall d'Hebron, Edificio General-Planta Baja, UITM, Unidad de Farmacia de Ensa
Barcelona Catalonia, 08035, Spain
Hospital Universitario La Paz
Madrid Madrid Provincia, 28046, Spain
Institut Catala d'Oncologia
Badalona , 08916, Spain
Hospital Universitario Virgen de las Nieves
Granada , 18014, Spain
Hospital Universitario Lucus Augusti
Lugo , 27003, Spain
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid , 28007, Spain
Hospital 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario HM Sanchinarro
Madrid , 28050, Spain
Fundacion Instituto Valenciano de Oncologia
Valencia , 46009, Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain
Sbu Dr. A.Y. Ankara Onkoloji Suam
Ankara Anatolia, 06100, Turkey
Gulhane Egitim ve Arastirma Hastanesi
Keçiören Ankara, 06010, Turkey
Liv Hospital
Ankara Central Anatolia, 06010, Turkey
Ankara Memorial Hospital
Ankara Central Anatolia, 06520, Turkey
Adana Kisla Baskent Unv Hospital
Adana Cilicia, 01120, Turkey
Dicle University, Faculty of Medicine
Diyarbakir Diyarbakir Province, 21280, Turkey
Trakya Universitesi, Balkan Onkoloji Hastanesi Linik Arastirmar Odasi
Iskender Edime, 22130, Turkey
Medical Park Gaziantep Hastanesi
Sehitkamil Gaziantep, 27310, Turkey
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul Istanbul Province, 81450, Turkey
Istanbul Universitesi CerrahpaSa- Cerrahpasa Tip Fakultesi
Fatih Istanbul, 34098, Turkey
Izmir Katip Celebi University Ataturk training and Research Hospital
Izmir Izmir Province, 35360, Turkey
Kocaeli University Hospital
Umuttepe Kocaeli, 41380, Turkey
Royal Devon University Healthcare NHS Foundation Trust, Clinical Trials Pharmacy
Exeter Devon, EX2 5, United Kingdom
Clinical research pharmacy
Chelsea London, SW3 6, United Kingdom
Pharmacy Clinical Trials, Pharmacy Department, Alexander Donald Building, Western General Hospital
Edinburgh Lothian, EH4 2, United Kingdom
Clinical Trials Unit Bristol Haematology & Oncology Centre
Bristol Somerset, BS2 8, United Kingdom
Musgrove Park Hospital, Somerset Foundation Trust
Taunton Somerset, TA1 5, United Kingdom
Pharmacy Chemotherapy Unit, St Barthomews Hospital West Smithfield
London , EC1A , United Kingdom
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

1530

Study ID:

NCT05608291

Recruitment Status:

Recruiting

Sponsor:


Regeneron Pharmaceuticals

How clear is this clinincal trial information?

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