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
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 183 Locations for this study
La Jolla California, 92093, United States
San Francisco California, 94158, United States
Santa Monica California, 90404, United States
Englewood Colorado, 80113, United States
Miami Florida, 33176, United States
Orlando Florida, 32806, United States
Chicago Illinois, 60611, United States
Boston Massachusetts, 02114, United States
New Brunswick New Jersey, 08901, United States
New York New York, 10016, United States
New York New York, 10032, United States
Rochester New York, 14642, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Easton Pennsylvania, 18045, United States
Philadelphia Pennsylvania, 19107, United States
Knoxville Tennessee, 37920, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75390, United States
Murray Utah, 84107, United States
Charlottesville Virginia, 22908, United States
Fairfax Virginia, 22031, United States
Ciudad Autonoma Buenos Aires, C1125, Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Viedma Rio Negro, 8500, Argentina
Rosario Santa Fe, S2000, Argentina
San Miguel de Tucumán Tacuman Province, 4000, Argentina
Liverpool New South Wales, 2170, Australia
Adelaide South Australia, 5006, Australia
Bedford Park South Australia, 5042, Australia
Box Hill Victoria, 3128, Australia
Geelong Victoria, 3220, Australia
Melbourne Victoria, 3004, Australia
Nedlands Western Australia, 6009, Australia
Sint Niklaas East Flanders, 9100, Belgium
Brussels Region De Bruxelles, 1200, Belgium
Kortrijk West-Vlaaderen, 8500, Belgium
Belo Horizonte Minas Geraise, 30130, Brazil
Curitiba Parana, 81520, Brazil
Ijui Rio Grande Do Sul, 98700, Brazil
Passo Fundo Rio Grande Do Sul, 99010, Brazil
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Itajai Santa Catarina, 88301, Brazil
Joinville Santa Catarina, 89201, Brazil
Lages Santa Catarina, 88501, Brazil
Sao Paulo Sao Paulo Estado, 01236, Brazil
Barretos Sao Paulo, 14784, Brazil
Sao Paulo , 01308, Brazil
Sao Paulo , 14784, Brazil
Fredericton New Brunswick, E3B5N, Canada
Barrie Ontario, L4M 6, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Santiago Metropolitana De Santiago, 75609, Chile
Santiago Metropolitana De Santiago, 76200, Chile
Santiago Santiago Region Metropolitana De Santiago, 75100, Chile
Valparaiso , 25205, Chile
Hradec Kralove Bohemia, 50005, Czechia
Ostrava Moravia Region, 70852, Czechia
Brno South Moravian, 65653, Czechia
Dijon Bourgogne-Franche-Comte, 21000, France
Dijon Bourgogne-Franche-Comté, 21079, France
Besancon Cedex Bourgogne, 25030, France
La Tronche Grenoble, 38700, France
Toulouse Haute-Garonne, 31059, France
Vaillant Ile De France, 94805, France
Paris Ile-de-France, 75010, France
Lille Nord Deparment, 59037, France
Caen Normandy, 14076, France
Bordeaux Nouvelle-Aquitaine, 33075, France
Montpellier Occitanie Region, 34090, France
Boulogne Billancourt Paris, 92100, France
Creteil Paris, 94000, France
Nantes Pays De La Loire Région, 44000, France
Avignon Province Alpes Cote d'Azur, 84918, France
Clermont-Ferrand Puy-de-Dôme, 63003, France
Le Mans Sarthe, 72037, France
Bobigny Seine Saint Denis, 93000, France
Amiens Somme, 80054, France
Nice , 06200, France
Rouen , 76031, France
Batumi Adjara, 6000, Georgia
T'bilisi South Caucasus, 0112, Georgia
T'bilisi South Caucasus, 0112, Georgia
T'bilisi South Caucasus, 0114, Georgia
T'bilisi South Caucasus, 0144, Georgia
T'bilisi South Caucasus, 0168, Georgia
Tbilisi South Caucasus, 0159, Georgia
Mannheim Baden-Wurttemberg, 68167, Germany
Tubingen Baden-Wurttemberg, 72076, Germany
Erlangen Bavaria, 91054, Germany
Munchen Bavaria, 80337, Germany
Darmstadt Hessen, 64283, Germany
Gottingen Lower Saxony, 37075, Germany
Schwerin Mecklenburg Vorpommern, 19055, Germany
Muenster North Rhine-Westphalia, 48149, Germany
Muenster North Rhine-Westphalia, 48157, Germany
Ludwigshafen Rhindeland Palatinate, 67063, Germany
Quedlinburg Sachsen-Anhalt, 06484, Germany
Dresden Saxony, 01307, Germany
Kiel Schleswig-Holstein, 24105, Germany
Berlin , 10117, Germany
Bochum , 44791, Germany
Bremen , 28325, Germany
Erfurt , 99089, Germany
Essen , 45147, Germany
Regensburg , 93053, Germany
Goudi Athens, 11527, Greece
Athens Pireas, 18547, Greece
Thessaloniki Pylaia, 54622, Greece
Thessaloniki Pylaia, 57001, Greece
Efkarpia Thessalonili, 56403, Greece
Galway Connacht, H91 Y, Ireland
Beaumont Dublin, D09V2, Ireland
Cork Munster, , Ireland
Dublin , D04 T, Ireland
Afula Northern District, 18341, Israel
Ramat-Gan Tel Aviv, 52621, Israel
Jerusalem , 91120, Israel
L'Aquila Abruzzo, 67100, Italy
Napoli Campania, 80121, Italy
Napoli Campania, 80131, Italy
Udine Friuli-Venezia Giulia, 33100, Italy
Rome Lazio, 00128, Italy
Rome Lazio, 00168, Italy
Milan Lombardy, 20141, Italy
Bari Metropolitan City Of Bari, 70124, Italy
Roma Rome Province, 00167, Italy
Perugia Umbria, 06132, Italy
Cona Veneto, 44124, Italy
Novara , 28100, Italy
Taormina , 98039, Italy
Torrette , 60126, Italy
Trento , 38123, Italy
Leon Guanajuato Guanajuato, 37178, Mexico
Guadalajara Jalisco, 44280, Mexico
Zapopan Jalisco, 45070, Mexico
Monterrey Nuevo Leon, 64710, Mexico
Culiacan Sinaloa, 80020, Mexico
Veracruz Veracruz Estado, 91900, Mexico
Merida Yucatan, 97134, Mexico
Siedlce Mazowieckie, 08-11, Poland
Gdansk Pomeria, 80-21, Poland
Slupsk Pomorskie, 16-20, Poland
Craiova Dolj, 20054, Romania
Cluj Floresti, 40728, Romania
Iași Moldava, 70010, Romania
Timisoara Timis, 30021, Romania
Timisoara Timis, 30023, Romania
Cluj Napoca Transylvania, 40001, Romania
Cluj Napoca Transylvania, 40001, Romania
Bucharest , 02232, Romania
Johannesburg Gauteng, 2196, South Africa
Pretoria Gauteng, 7570, South Africa
Cape Town Western Cape, 7570, South Africa
Sevilla Andalucia, 41009, Spain
Oviedo Asturias, 33011, Spain
Santander Cantabria, 39008, Spain
Barcelona Catalonia, 08028, Spain
Barcelona Catalonia, 08035, Spain
Barcelona Catalonia, 08035, Spain
Madrid Madrid Provincia, 28046, Spain
Badalona , 08916, Spain
Granada , 18014, Spain
Lugo , 27003, Spain
Madrid , 28007, Spain
Madrid , 28041, Spain
Madrid , 28050, Spain
Valencia , 46009, Spain
Valencia , 46010, Spain
Ankara Anatolia, 06100, Turkey
Keçiören Ankara, 06010, Turkey
Ankara Central Anatolia, 06010, Turkey
Ankara Central Anatolia, 06520, Turkey
Adana Cilicia, 01120, Turkey
Diyarbakir Diyarbakir Province, 21280, Turkey
Iskender Edime, 22130, Turkey
Sehitkamil Gaziantep, 27310, Turkey
Istanbul Istanbul Province, 81450, Turkey
Fatih Istanbul, 34098, Turkey
Izmir Izmir Province, 35360, Turkey
Umuttepe Kocaeli, 41380, Turkey
Exeter Devon, EX2 5, United Kingdom
Chelsea London, SW3 6, United Kingdom
Edinburgh Lothian, EH4 2, United Kingdom
Bristol Somerset, BS2 8, United Kingdom
Taunton Somerset, TA1 5, United Kingdom
London , EC1A , United Kingdom
Manchester , M20 4, United Kingdom
How clear is this clinincal trial information?