Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

A Phase 2 and Phase 3 Trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called REGN2810, also known as cemiplimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on patients with a type of skin cancer known as melanoma.

The aims of the study are to see how effective the combination of fianlimab and cemiplimab are in treating the melanoma skin cancer, in comparison with a medication, pembrolizumab, approved for the treatment of melanoma skin cancer in adults, and to observe any similarities, or differences, in how the study drugs work in adolescent participants compared with adult participants.

The study is looking at several other research questions, including:

• What side effects may happen from receiving the study drugs
• How much study drug is in the blood at different times
• Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections.
• How administering the study drugs might improve quality of life

Study Overview

• Status: Recruiting
• Conditions: Melanoma
• Intervention / Treatment: Drug: Placebo; Drug: Pembrolizumab; Drug: Fianlimab; Drug: Cemiplimab

• Study Type: Interventional
• Enrollment (Estimated): 1925
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Trials Administrator; Phone Number: 844-734-6643; Email: clinicaltrials@regeneron.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1061
    • Recruiting
    • DIABAID - Instituto de Asistencia Integral en Diabetes
  • Caba, Argentina, C1430EGF
    • Recruiting
    • Clínica Adventista Belgrano
  • Ciudad Autonoma de Buenos Aires, Argentina, C1125ABD
    • Recruiting
    • Fundacion CENIT Centro Medico de Neurociencias
  • Rosario, Argentina, S2000KZE
    • Recruiting
    • Instituto de Oncologia de Rosario
  • San Miguel de Tucuman, Argentina, 4000
    • Recruiting
    • Centro Medico San Roque
• Australia
  • Adelaide, Australia, 05006
    • Recruiting
    • Calvary North Adelaide Hospital
  • Geelong, Australia, 03220
    • Recruiting
    • Barwon Health Andrew Love Cancer Centre, University Hospital Geelong
  • Hobart, Australia, 7000
    • Recruiting
    • Icon Cancer Centre Hobart
    • Contact: Phone Number: 362402600
  • Melbourne, Australia, 03004
    • Recruiting
    • The Alfred Hospital
  • Southport, Australia, 4215
    • Suspended
    • Gold Coast University Hospital
  • Townsville, Australia, 04814
    • Recruiting
    • The Townsville Hospital and Health Service
  • Wendouree, Australia, 03355
    • Recruiting
    • Ballarat Oncology and Haematology Clinical Trials Unit
• Austria
  • Graz, Austria, 8036
    • Recruiting
    • Medical University of Graz
  • St. Poelten, Austria, 3100
    • Recruiting
    • University Hospital St. Poelten
  • Vienna, Austria, 01090
    • Recruiting
    • Medical University of Vienna
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Recruiting
      • Medical University Innsbruck
• Belgium
  • Brussels, Belgium, 01200
    • Recruiting
    • Cliniques universitaires Saint-Luc
  • Kortrijk, Belgium, 08500
    • Recruiting
    • AZ Groeninge, Campus Kennedylaan
  • Namur, Belgium, 05000
    • Recruiting
    • Clinique et Maternite Sainte-Elisabeth (CMSE)
  • Sint Niklaas, Belgium, 09100
    • Recruiting
    • AZ Nikolaas
• Brazil
  • Barretos, Brazil, 14784-400
    • Recruiting
    • Fundação Pio XII - Hospital de Amor de Barretos
  • Belo Horizonte, Brazil, 30130-090
    • Recruiting
    • Centro Avancado de Tratamento Oncologico (CENANTRON)
  • Curitiba, Brazil, 81520-060
    • Recruiting
    • Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
  • Ijui, Brazil, 98700-000
    • Recruiting
    • ONCOSITE Centro de Pesquisa Clínica Em Oncologia
  • Itajai, Brazil, 88301-220
    • Recruiting
    • Clinica de Neoplasias Litoral/atarina Pesquisa Clínica
  • Joinville, Brazil, 89201-260
    • Recruiting
    • Instituto Joinvilense de Hematologia e Oncologia
  • Lages, Brazil, 88501-001
    • Recruiting
    • Animi Unidade de Tratamento Oncologico Ltda
  • Lajeado, Brazil, 95900-000
    • Recruiting
    • Hospital Bruno Born
  • Passo Fundo, Brazil, 99010-080
    • Recruiting
    • Hospital Sao Vicente de Paulo (HSVP) Instituto do Cancer
  • Porto Alegre, Brazil, 90035-903
    • Recruiting
    • Hospital de Clinicas de Porto Alegre (HCPA)
  • Porto Alegre, Brazil, 90035-001
    • Recruiting
    • Hospital Moinhos de Vento
  • Porto Alegre, Brazil, 90610-000
    • Recruiting
    • CPO - Centro de Pesquisas em Oncologia
  • Porto Velho, Brazil, 76834-899
    • Recruiting
    • Fundacao PIO XII - Hospital de Amor Amazonia
  • Rio de Janeiro, Brazil, 22793080
    • Recruiting
    • Instituto Coi
  • Salvador, Brazil, 41253- 190
    • Recruiting
    • Hospital Sao Rafael
  • Santo Cristo, Brazil, 20220-410
    • Recruiting
    • INCA - Brazilian National Cancer Institute
  • Sao Jose do Rio Preto, Brazil, 15090-000
    • Recruiting
    • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
  • Sao Paulo, Brazil, 04014-002
    • Recruiting
    • Sao Camilo Oncologia
  • Sao Paulo, Brazil, 01308-050
    • Recruiting
    • Hospital Sirio Libanes (HSL)
  • Sao paulo, Brazil, 01236-030
    • Recruiting
    • Hemomed
• Canada
  • Barrie, Canada, L4M 6M2
    • Recruiting
    • Royal Victoria Regional Health Centre
  • Edmonton, Canada, T6G-1Z2
    • Recruiting
    • Cross Cancer Institute (CCI)
  • Fredericton, Canada, E3B5N5
    • Recruiting
    • Dr. Everett Chalmers Hospital
  • Saskatoon, Canada, S7N 4H4
    • Recruiting
    • Saskatoon Cancer Centre (SCC)
  • Toronto, Canada, M5G 2M9
    • Recruiting
    • University Health Network, Princess Margaret Cancer Centre
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Research Institute
• Chile
  • Antofagasta, Chile, 1240000
    • Recruiting
    • Centro Oncologico Antofagasta Bradford Hill Norte
  • Santiago, Chile, 7560907
    • Recruiting
    • Universidad Mayor - Centro Oncologia de Precision
  • Vina del Mar, Chile, 2520598
    • Recruiting
    • OncoCentro
  • Chi
    • Recoleta, Chi, Chile, 8420000
      • Recruiting
      • Centro de Investigacion Clinica Bradford Hill
  • Region Metropolitana De Santiago
    • Santiago, Region Metropolitana De Santiago, Chile, 7510032
      • Recruiting
      • Oncovida
• Czechia
  • Hradec Kralove, Czechia, 50005
    • Recruiting
    • Fakultni nemocnice Hradec Kralove
  • Ostrava, Czechia, 70852
    • Recruiting
    • University Hospital Ostrava
  • Prague 10, Czechia, 10034
    • Recruiting
    • Fakultni nemocnice Kralovske Vinohrady, Dermatovenerologicka klinika
• France
  • Besancon Cedex, France, 25030
    • Recruiting
    • CHU Jean Minjoz
  • Bobigny, France, 93000
    • Recruiting
    • Hopital Avicenne Service de Dermatologie du Pr Caux
  • Bordeaux Cedex, France, 033075
    • Recruiting
    • HOPITAL SAINT ANDRE Chu De Bordeaux
  • Boulogne Billancourt, France, 92100
    • Recruiting
    • Hopital Ambroise Pare
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU Estaing, Service de Dermatologie
  • Creteil, France, 94010
    • Recruiting
    • Hopitaux Universitaires Henri-Mondor
  • Dijon, France, 021000
    • Recruiting
    • CHU de DIJON - Service de Dermatologie
  • Grenoble, France, 38700
    • Recruiting
    • Centre Hospitalier Universitaire De Grenoble Alpes Service Dermatologie
  • Le Mans, France, 72037
    • Recruiting
    • CH Le Mans - Plateforme de recherche clinique
  • Lille Cedex, France, 59037
    • Recruiting
    • CHRU de Lille
  • Lyon cedex 08, France, 69373
    • Recruiting
    • Centre Leon Berard
  • Nantes, France, 44000
    • Recruiting
    • Centre Hospitalier Universitaire de Nantes (CHU de Nantes) Hotel Dieu
  • Paris, France, 75005
    • Recruiting
    • Hôpital Cochin APHP
  • Pierre Benite Cedex, France, 69495
    • Recruiting
    • Hospices Civils de Lyon
  • Poitiers Cedex, France, 86021
    • Recruiting
    • Hopital de la Miletrie Centre Hospitalier Universitaire de Poitiers
  • Rouen, France, 76031
    • Recruiting
    • CHU Charles Nicolle Dermatologie
  • Saint-Etienne, France, 42055
    • Recruiting
    • CHU Saint-Etienne - Hopital Nord
  • Strasbourg, France, 67000
    • Recruiting
    • Clinique Sainte Anne/Strasbourg Oncologie Liberale
  • Villejuif Cedex, France, 94805
    • Recruiting
    • Institut Gustave Roussy Cancer Center DITEP
• Georgia
  • Batumi, Georgia, 6000
    • Recruiting
    • LTD High Technology Hospital Medcenter
    • Contact: Phone Number: 568999559
  • Tbilisi, Georgia, 0114
    • Recruiting
    • Ltd New Hospitals
    • Contact: Phone Number: 95599373303
  • Tbilisi, Georgia, 0144
    • Recruiting
    • LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
    • Contact: Phone Number: 851667553
  • Tbilisi, Georgia, 0160
    • Recruiting
    • TIM -Tbilisi Institute of Medicine
    • Contact: Phone Number: 995 595959570
  • Tbilisi, Georgia, 0168
    • Recruiting
    • Medulla - Clinics And Medical Centers
    • Contact: Phone Number: 995 568 155 755
  • Tbilisi, Georgia, 112
    • Recruiting
    • LLC Todua Clinic
    • Contact: Phone Number: +995 599117976
  • Tbilisi, Georgia, 0112
    • Recruiting
    • Israeli Georgian medical research clinic Helsicore
  • Tbilisi, Georgia, 0159
    • Recruiting
    • JSC K. Eristavi National Center of Experimental and Clinical Surgery
• Germany
  • Augsburg, Germany, 86179
    • Recruiting
    • Universitatsklinikum Augsburg Klinik fur Dermatologie und Allergologie Campus Sud
  • Berlin, Germany, 10117
    • Recruiting
    • Charite - Universitaetsmedizin Berlin
  • Bochum, Germany, 44791
    • Recruiting
    • Universitaetsklinikum der Ruhr Universitaet Bochum (UKRUB) St Josef Hospital
  • Buxtehude, Germany, 21614
    • Recruiting
    • Elbekliniken Buxtehude
  • Dresden, Germany, 01307
    • Recruiting
    • Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet
  • Erfurt, Germany, 99089
    • Recruiting
    • Helios Klinikum Erfurt Klinik fur Hautkrankheiten und Allergologie
  • Frankfurt, Germany, 60590
    • Suspended
    • Universitätsklinik Frankfurt
  • Giessen, Germany, 35392
    • Recruiting
    • University Hospital Gießen
  • Göttingen, Germany, 37075
    • Recruiting
    • Universitatsmedizin Gottingen Klinik fur Dermatologie
  • Kiel, Germany, 24105
    • Recruiting
    • University of Kiel
  • Leipzig, Germany, 4103
    • Recruiting
    • Universitaetsklinikum Leipzig
  • Luebeck, Germany, 23538
    • Recruiting
    • Universitaetsklinikum Schleswig-Holstein Campus Luebeck
  • Mannheim, Germany, 68167
    • Recruiting
    • University Medical Center Mannheim
  • Muenster, Germany, 48157
    • Recruiting
    • Fachklinik Hornheide
  • Quedlinburg, Germany, 06484
    • Recruiting
    • Harzklinikum, Klinik fur Dermatologie und Allergologie
  • Regensburg, Germany, 93053
    • Recruiting
    • University Clinic Regensburg
  • Schwerin, Germany, 19055
    • Recruiting
    • Helios Klinik Schwerin
• Hungary
  • Debrecen, Hungary, 4032
    • Recruiting
    • University of Debrecen
  • Nyíregyhaza, Hungary, 04400
    • Recruiting
    • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhazak
  • Pecs, Hungary, 7632
    • Recruiting
    • University of Pecs Medical School
  • Szeged, Hungary, 06720
    • Recruiting
    • University of Szeged
• Ireland
  • Cork, Ireland, T12 E8YV
    • Recruiting
    • Cork University Hospital
  • Dublin, Ireland, D08 NHY1
    • Recruiting
    • St. James Hospital
  • Dublin 4, Ireland, D04 T6F4
    • Recruiting
    • St. Vincents University Hospital
    • Contact: Phone Number: 353 1 261 4030
  • Galway, Ireland, H91 YR71
    • Recruiting
    • University College Hospital Galway
• Italy
  • Bari, Italy, 70124
    • Recruiting
    • Istituto dei Tumori
  • Brescia, Italy, 25123
    • Recruiting
    • ASST Spedali Civili Brescia
  • Candiolo, Italy, 10060
    • Recruiting
    • Istituto di Candiolo, FPO IRCCS
  • Cuneo, Italy, 12100
    • Recruiting
    • Azienda Sanitaria Ospedaliera Santa Croce E Carle - Cuneo
  • Genova, Italy, 16132
    • Recruiting
    • Ospedale Policlinico San Martino - IRCCS
  • Monza, Italy, 20052
    • Recruiting
    • Fondazione IRCCS San Gerardo dei Tintori
  • Napoli, Italy, 80131
    • Recruiting
    • IRCCS Istituto Nazionale dei Tumori di Napoli Fondazione G. Pascale
  • Napoli, Italy, 80121
    • Recruiting
    • Universita della Campania Luigi Vanvitella
  • Novara, Italy, 28100
    • Recruiting
    • SCDU di Oncologia AOU Maggiore Della Carita
  • Padova, Italy, 35128
    • Recruiting
    • IOV - Istituto Oncologico Veneto - IRCCS
  • Pisa, Italy, 56126
    • Recruiting
    • U.O. Oncologia Medica Universitaria - Istituto Toscano Tumori Polo Oncologico
  • Rome, Italy, 00167
    • Recruiting
    • Istituto Dermopatico Dell'Immacolata Irccs
  • Rome, Italy, 00128
    • Recruiting
    • Campus Bio-Medico di Roma
  • San Giovanni Rotondo, Italy, 71013
    • Recruiting
    • Fondazione IRCSS Casa Sollievo Della Sofferenza
  • Terni, Italy, 05100
    • Recruiting
    • Azienda Ospedaliera S. Maria
  • Trento, Italy, 38123
    • Recruiting
    • Santa Chiara Regional Hospital
  • Turin, Italy, 10126
    • Recruiting
    • AOU Citta della Salute e della Scienza di Torino
  • Udine, Italy, 33100
    • Recruiting
    • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - Ospedale Udine
• Mexico
  • Chihuahua, Mexico, 31000
    • Recruiting
    • Centro Estatal de Cancerología de Chihuahua
  • Culiacan, Mexico, 80020
    • Recruiting
    • Neurociencias Estudios Clínicos SC
  • Guadalajara, Mexico, 44280
    • Recruiting
    • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
  • Leon, Mexico, 37178
    • Recruiting
    • Preparaciones Oncologicas SC
  • Merida, Mexico, 97134
    • Recruiting
    • Centro De Atencion E Investigacion Clinica En Oncologia Scp
  • Monterrey, Mexico, 64710
    • Suspended
    • iCan Oncology Center
  • Tuxtla Gutierrez, Mexico, 290838
    • Recruiting
    • Centro De Estudios Y Prevencion Del Cancer A. C.
  • Veracruz, Mexico, 91900
    • Recruiting
    • FAICIC S. de R.L. de C.V.
  • Zapopan, Mexico, 45070
    • Recruiting
    • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Recruiting
    • The Netherlands Cancer Institute (NKI) - Antoni van Leeuwenhoek Hospital
  • Groningen, Netherlands, 9713 GZ
    • Recruiting
    • University Medical Center Groningen
• Peru
  • Arequipa, Peru, 04001
    • Recruiting
    • Centro Medico Monte Carmelo
  • Bellavista, Peru, 07001
    • Recruiting
    • Hospital Nacional Daniel Alcides Carrion
  • Concepcion, Peru, 12125
    • Recruiting
    • Instituto Regional de Enfermedades Neoplasicas del Centro - IREN CENTRO
  • Lima, Peru, 15036
    • Suspended
    • Instituto Peruano de Oncologia and Radioterapia
  • Trujillo, Peru, 13011
    • Recruiting
    • Clinica Peruano Americana
• Poland
  • Gdansk, Poland, 80-214
    • Recruiting
    • Uniwersyteckie Centrum Kliniczne (UCK)
  • Krakow, Poland, 31-115
    • Recruiting
    • Narodowego Instytutu Onkologii im Maria Sklodowska Curie
  • Poznan, Poland, 60-780
    • Recruiting
    • Uniwersytecki Szpital Kliniczny w Poznaniu
  • Siedlce, Poland, 08-110
    • Recruiting
    • Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii
  • Slupsk, Poland, 76-200
    • Recruiting
    • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
  • Warszawa, Poland, 02-781
    • Recruiting
    • Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
• Romania
  • Bucharest, Romania, 22328
    • Recruiting
    • Institute of Oncology Bucharest
  • Cluj, Romania, 407280
    • Recruiting
    • Sc Radiotherapy Center Cluj Srl
  • Cluj Napoca, Romania, 400641
    • Recruiting
    • Medisprof
  • Cluj-Napoca, Romania, 400015
    • Recruiting
    • Cardiomed SRL
  • Craiova, Romania, 200347
    • Recruiting
    • Centrul de Oncologie Sf. Nectarie S.R.L
  • Iasi, Romania, 700106
    • Recruiting
    • SC Centrul de Oncologie Euroclinic SRL
  • Iasi, Romania, 700383
    • Recruiting
    • Regional Institute of Oncology
  • Otopeni, Romania, 075100
    • Recruiting
    • RTC Radiology Therapeutic Center SRL
  • Timisoara, Romania, 300210
    • Recruiting
    • Oncocenter Oncologie clinica S.R.L
  • Timisoara, Romania, 300239
    • Recruiting
    • Oncomed
• South Africa
  • Cape Town, South Africa, 7925
    • Recruiting
    • Groote Schuur Hospital
  • Johannesburg, South Africa, 02196
    • Recruiting
    • The Medical Oncology Centre of Rosebank
  • Kraaifontein, South Africa, 7570
    • Recruiting
    • Cape Town Oncology Trials
• Spain
  • A Coruna, Spain, 15009
    • Recruiting
    • Hospital Teresa Herrera-Chuac (CHUAC)
  • Badalona, Spain, 08916
    • Recruiting
    • Hospital Universitari Germans Trias i Pujol (HUGTP)
  • Barcelona, Spain, 08028
    • Recruiting
    • Instituto Oncologico Dr Rosel
  • Barcelona, Spain, 08907
    • Recruiting
    • Catalan Institute of Oncology (ICO) Hospitalet
  • Barcelona, Spain, 08041
    • Suspended
    • Hospital de La Santa Creu i Sant Pau
  • Cordoba, Spain, 14004
    • Recruiting
    • Hospital Universitario Reina Sofia
  • Girona, Spain, 17007
    • Recruiting
    • Catalan Institute Of Oncology - Girona
  • Granada, Spain, 18014
    • Recruiting
    • Hospital Universitario Virgen de las Nieves
    • Contact: Phone Number: 34 958020000
  • Lugo, Spain, 27003
    • Recruiting
    • Hospital Universitario Lucus Augusti
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Fundación Jiménez Díaz
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz
  • Madrid, Spain, 28007
    • Recruiting
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28050
    • Recruiting
    • Centro integral Oncologico HM Clara Campal
  • Malaga, Spain, 29011
    • Recruiting
    • Hospital Regional Universitario de Malaga
  • Múrcia, Spain, 30120
    • Recruiting
    • Hospital Universitario Virgen de la Arrixaca
  • Oviedo, Spain, 33011
    • Recruiting
    • Hospital Universitario Central de Asturias
  • San Sebastian, Spain, 20014
    • Recruiting
    • Onkologikoa
  • Sevilla, Spain, 41009
    • Recruiting
    • Hospital Universitario Virgen Macarena
  • Valencia, Spain, 46009
    • Recruiting
    • Instituto Valenciano de Oncologia
  • Valencia, Spain, 46010
    • Recruiting
    • INCLIVA-Instituto de Investigacion Sanitaria
• Turkey
  • Adana, Turkey, 01120
    • Recruiting
    • Adana Baskent Hospital
  • Ankara, Turkey, 06010
    • Recruiting
    • Gulhane Training and Research Hospital
  • Ankara, Turkey, 06520
    • Recruiting
    • Memorial Ankara Hospital
  • Ankara, Turkey, 06680
    • Recruiting
    • Ozel Liv Hospital
  • Diyarbakir, Turkey, 21200
    • Recruiting
    • Dicle University Medical Faculty
  • Edirne, Turkey, 22000
    • Recruiting
    • Trakya University
  • Gaziantep, Turkey, 27584
    • Recruiting
    • Gaziantep University Medical Faculty
  • Istanbul, Turkey, 34093
    • Recruiting
    • Bezmialem University
  • Istanbul, Turkey, 34098
    • Recruiting
    • Cerrahpasa Medical Hospital
  • Istanbul, Turkey, 34722
    • Recruiting
    • Prof. Dr. Suleyman Yalcin Sehir Hospital
  • Istanbul, Turkey, 34147
    • Recruiting
    • Bakirkoy Sadi Konuk Training Hospital
  • Kocaeli, Turkey, 41100
    • Recruiting
    • Kocaeli Üniversitesi
• United Kingdom
  • Guildford, United Kingdom, GU2 7XX
    • Recruiting
    • Royal Surrey NHS Foundation Trust
  • Hull, United Kingdom, HU16 5JQ
    • Recruiting
    • Hull University Teaching Hospitals NHS Trust
  • Leeds, United Kingdom, LS9 7TF
    • Recruiting
    • Leeds Teaching Hospitals NHS Trust
  • London, United Kingdom, SE1 9RT
    • Suspended
    • Guy's Hospital
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Recruiting
      • Royal Devon and Exeter Hospital NHS Trust
• United States
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • University of California San Diego
    • Los Angeles, California, United States, 90025
      • Recruiting
      • The Angeles Clinic and Research Institute
      • Contact: Phone Number: 310-496-0679
  • Florida
    • Miami, Florida, United States, 33176
      • Recruiting
      • Miami Cancer Institute
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Orlando Health, Inc
      • Contact: Phone Number: 321-841-9821
  • New Jersey
    • Morristown, New Jersey, United States, 07962
      • Recruiting
      • Atlantic Health System - Morristown Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Foundation
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Seidmand Cancer Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Recruiting
      • University of Tennessee Medical Center
      • Contact: Phone Number: 865-305-4893

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Age ≥12 years on the date of providing informed consent

2. Patients with histologically confirmed unresectable Stage III and Stage IV (metastatic) melanoma (AJCC, 8th revised edition) who have not received prior systemic therapy for advanced unresectable disease

   1. Patients who received adjuvant and/or neoadjuvant systemic therapies are eligible if they did not have evidence of progression or recurrence of disease and/or discontinued due to occurrence of unmanageable imAEs ≥ grade 3 (with the exclusion of endocrinopathies which are fully controlled by hormone replacement) while on such therapies. Also, patients must have had a treatment-free and disease-free interval of >6 months. Accrual of these patients is limited to approximately 10% of the total population enrolled in each of the Phase 2 and Phase 3 parts of the study.
   2. Patients with acral and mucosal melanomas are eligible. Combined accrual will be limited to 10% of the total population enrolled in the Phase 3 part of the study.

3. Measurable disease per RECIST v1.1

   1. Previously irradiated lesions can only be counted as target lesions if they have been demonstrated to progress and no other target lesion is available
   2. Cutaneous lesions should be evaluated as non-target lesions

4. Performance status:

   1. For adult patients: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
   2. For pediatric patients: Karnofsky performance status ≥70 (patients ≥16 years) or Lansky performance status ≥70 (patients ≤16 years)
5. Anticipated life expectancy of at least 3 months

Key Exclusion Criteria:

1. Uveal melanoma
2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.
3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection
4. Unknown v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status as described in the protocol

5. Systemic immune suppression:

   1. Use of immunosuppressive doses of corticosteroids (>10mg of prednisone per day or equivalent) within 14 days of the first dose of study medication. Physiologic replacement doses are allowed up to and including 10mg of prednisone/day or equivalent. Inhaled or topical steroids are permitted, if they are not for treatment of an autoimmune disorder.
   2. Other clinically relevant forms of systemic immune suppression
6. Treatment with other anti-cancer therapy including immuno- therapy, chemotherapy, major surgery or biological therapy within 21 days prior to the first dose of trial treatment. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.
7. History or current evidence of significant (CTCAE Grade ≥2) local or systemic infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 14 days prior to the first dose of trial medication.
8. Participants with a history of myocarditis.

9. Active or untreated brain metastases or spinal cord compression. Patients with leptomeningeal disease are excluded. Patients with known brain metastases are eligible if they:

   1. Received radiotherapy or another appropriate standard therapy for the brain metastases,
   2. Have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment) for at least 14 days prior to enrollment
   3. Did not require immunosuppressive doses of corticosteroids therapy (>10mg of prednisone per day or equivalent) in the 14 days prior to enrollment
   4. Are asymptomatic with a single untreated brain metastasis <10 mm in size

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A: fianlimab+cemiplimab dose 1; Phase 2 and Phase 3	Drug: Fianlimab; Intravenous (IV) infusion; Other Names: REGN3767; Drug: Cemiplimab; IV infusion; Other Names: REGN2810; Libtayo
Experimental: A1: fianlimab+cemiplimab dose 2; Phase 2 and Phase 3 (except for PA1 patients as described in the protocol)	Drug: Fianlimab; Intravenous (IV) infusion; Other Names: REGN3767; Drug: Cemiplimab; IV infusion; Other Names: REGN2810; Libtayo
Experimental: B: pembrolizumab+placebo; Phase 2 and Phase 3	Drug: Placebo; IV infusion; Drug: Pembrolizumab; IV infusion; Other Names: Keytruda; lambrolizumab; MK-3475
Experimental: C: cemiplimab+placebo; Phase 2 (as described in the protocol)	Drug: Placebo; IV infusion; Drug: Cemiplimab; IV infusion; Other Names: REGN2810; Libtayo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	Phase 2 Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Blinded Independent Central Review (BICR)	Approximately 27 months
Progression-free survival (PFS)	Phase 3 Per RECIST 1.1 based on BICR	Approximately 27 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)		Up to 96 months
Incidence of laboratory abnormalities	Will be graded using the current version of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading system (version 5.0)	Up to 90 days post last dose, approximately 6 years
Concentrations of cemiplimab in serum		Up to 90 days post last dose, approximately 6 years
Concentrations of fianlimab in serum		Up to 90 days post last dose, approximately 6 years
Incidence of anti-drug antibodies (ADA) to fianlimab over time		Up to 30 days post last dose, approximately 6 years
Titer of anti-drug antibodies (ADA) to fianlimab over time		Up to 30 days post last dose, approximately 6 years
Incidence of ADA to cemiplimab over time		Up to 30 days post last dose, approximately 6 years
Titer of ADA to cemiplimab over time		Up to 30 days post last dose, approximately 6 years
Incidence of neutralizing antibodies (NAb) to fianlimab over time		Up to 30 days post last dose, approximately 6 years
Incidence of NAb to cemiplimab over time		Up to 30 days post last dose, approximately 6 years
Patient-reported outcomes (PROs) as measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)	EORTC-QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.	Up to 90 days post last dose, approximately 6 years
PROs as measured by EQ-5D-5L	The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Overall scores range from 0 to 1, with low scores representing a higher level of dysfunction.	Up to 90 days post last dose, approximately 6 years
PROs as measured by Patient Global Impression of Severity (PGIS)	The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe".	Up to 21 days post last dose, approximately 6 years
PROs as measured by Patient Global Impression of Change (PGIC)	The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change"	Up to 21 days post last dose, approximately 6 years
Change in physical functioning per EORTC QLQ-C30	EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.	Baseline to Week 25
Change in role functioning per EORTC QLQ-C30	EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.	Baseline to Week 25
Change in global health status/quality of life (GHS/QoL) per EORTC QLQ-C30	Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.	Baseline to Week 25
Change in physical functioning per EORTC QLQ-C30	EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.	Baseline to end of study, approximately 6 years
Change in role functioning per EORTC QLQ-C30	EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.	Baseline to end of study, approximately 6 years
Change in GHS/QoL per EORTC QLQ-C30	EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.	Baseline to end of study, approximately 6 years
PFS	Per RECIST 1.1 based on BICR or investigator assessment according to RECIST 1.1 and immune RECIST (iRECIST)	Up to 27 months
ORR	Per RECIST 1.1 based on BICR or investigator assessment according to RECIST 1.1 and iRECIST	Up to 27 months
Disease control rate (DCR)	Per RECIST 1.1 based on BICR or investigator assessment according to RECIST 1.1 and iRECIST	Up to 27 months
Duration of response (DoR)	Per RECIST 1.1 based on BICR or investigator assessment according to RECIST 1.1 and iRECIST	Up to 27 months
Incidence of Adverse Events (AEs)	Including treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and/ or immune-related adverse event (imAEs)	Up to 90 days post last dose, approximately 6 years
Occurrence of interruption and discontinuation of study drug(s) due to AEs	Including TEAEs, AESIs, and/ or imAEs	Up to 90 days post last dose, approximately 6 years
Incidence of deaths related to TEAEs		Up to 6 years
PROs as measured by Functional Assessment of Cancer Therapy melanoma (FACTM) (melanoma subscale only)	The FACTM is a melanoma-specific quality of life questionnaire that is composed of items from the Functional Assessment of Cancer Therapy-General (FACT-G). The FACTM is scored on a 5 point Likert-scale: "Not at all", "A little bit", "Somewhat", "Quite a bit", and "Very much.". A Higher score represents higher Health Related Quality of Life (HRQoL).	Up to 90 days post last dose, approximately 6 years

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2022
• Primary Completion (Estimated): March 3, 2026
• Study Completion (Estimated): August 31, 2032

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Metastatic; Unresectable; Stage III; Stage IV; Anti-Lymphocyte-activation gene 3 Pathway (LAG-3)
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Pembrolizumab; Cemiplimab
• Other Study ID Numbers: R3767-ONC-2011; 2021-004453-23 (EudraCT Number); 2023-505772-30-00 (Registry Identifier: EUCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
• IPD Sharing Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
• IPD Sharing Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No