A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma (RELATIVITY-127)

April 8, 2024 updated by: Bristol-Myers Squibb

A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma

The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

570

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain the NCT# and Site #.

Study Locations

  • Argentina
      • Cordoba, Argentina, 5000
        • Not yet recruiting
        • Local Institution - 0057
        • Contact:
          • Site 0057
      • Tucuman, Argentina, 4000
        • Not yet recruiting
        • Local Institution - 0020
        • Contact:
          • Site 0020
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, 1125
        • Withdrawn
        • Local Institution - 0042
      • Caba, Buenos Aires, Argentina, 1125
        • Not yet recruiting
        • Local Institution - 0023
        • Contact:
          • Site 0023
      • Caba, Buenos Aires, Argentina, C1187
        • Not yet recruiting
        • Local Institution - 0067
        • Contact:
          • Site 0067
      • Caba, Buenos Aires, Argentina, C1426ANZ
        • Not yet recruiting
        • Local Institution - 0070
        • Contact:
          • Site 0070
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1426
        • Not yet recruiting
        • Local Institution - 0133
        • Contact:
          • Site 0133
    • Ciudad Autonoma De Buenos Aires
      • Caba, Ciudad Autonoma De Buenos Aires, Argentina, 1430
        • Not yet recruiting
        • Local Institution - 0145
        • Contact:
          • Site 0145
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Not yet recruiting
        • Local Institution - 0160
        • Contact:
          • Site 0160
  • Australia
    • New South Wales
      • Coffs Harbour, New South Wales, Australia, 2450
        • Recruiting
        • North Coast Area Health Service NCAHS - The North Coast Cancer Institute NCCI - Coffs Harbour Health Campus
        • Contact:
          • Karen Briscoe, Site 0050
          • Phone Number: 61266565737
      • Orange, New South Wales, Australia, 2800
        • Recruiting
        • Orange Health Service
        • Contact:
          • Matteo Carlino, Site 0175
          • Phone Number: 61298455200
      • Port Macquarie, New South Wales, Australia, 2444
        • Recruiting
        • Port Macquarie Base Hospital
        • Contact:
          • Georgia Ritchie, Site 0172
          • Phone Number: 61265801818
      • Wagga Wagga, New South Wales, Australia, 2650
        • Recruiting
        • Riverina Cancer Care Centre
        • Contact:
          • David Palmieri, Site 0118
          • Phone Number: 0407793592
      • Waratah, New South Wales, Australia, 2298
        • Not yet recruiting
        • Local Institution - 0184
        • Contact:
          • Site 0184
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital
        • Contact:
          • Matteo Carlino, Site 0033
          • Phone Number: 61298455200
      • Wollstonecraft, New South Wales, Australia, 2065
        • Recruiting
        • University of Sydney - Melanoma Institute Australia MIA
        • Contact:
          • Georgina Long, Site 0055
          • Phone Number: 61299117336
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Recruiting
        • Sunshine Coast University Private Hospital
        • Contact:
          • Jeremy Long, Site 0090
          • Phone Number: +0428190959
    • South Australia
      • Woodville South, South Australia, Australia, 5011
        • Not yet recruiting
        • Local Institution - 0183
        • Contact:
          • Site 0183
    • Victoria
      • Bendigo, Victoria, Australia, 3550
        • Recruiting
        • Bendigo Health - Bendigo Cancer Centre
        • Contact:
          • Samuel Harris, Site 0008
          • Phone Number: 61354548815
      • Box Hill, Victoria, Australia, 3128
        • Recruiting
        • Local Institution - 0059
        • Contact:
          • Site 0059
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Austin Hospital - Medical Oncology Unit
        • Contact:
          • Damien Kee, Site 0154
          • Phone Number: 61385595000
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
        • Contact:
          • Andrew Haydon, Site 0030
          • Phone Number: 61390763129
      • Traralgon, Victoria, Australia, 3844
        • Recruiting
        • Latrobe Regional Health
        • Contact:
          • Quan Tran, Site 0109
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Sir Charles Gairdner Hospital
        • Contact:
          • Peter Lau, Site 0106
          • Phone Number: +618 6457 3333
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • One Clinical Research
        • Contact:
          • Adnan Khattak, Site 0161
          • Phone Number: 61861526726
  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Local Institution - 0027
        • Contact:
          • Site 0027
      • Salzburg, Austria, 5020
        • Recruiting
        • Universitatsklinik fur Dermatologie der Paracelsus medizinischen Privatuniversitat Salzburg
        • Contact:
          • Peter Koelblinger, Site 0029
          • Phone Number: 435725557842
      • St. Polten, Austria, 3100
        • Recruiting
        • Department of Dermatology, University Hospital St. Poelten
        • Contact:
          • Christine Hafner, Site 0168
          • Phone Number: +432742900411091
      • Wien, Austria, 1090
        • Recruiting
        • Medizinische Universitaet WienAKH, Dpt. of Dermatology
        • Contact:
          • Christoph Hoeller, Site 0037
          • Phone Number: +4314040077070
  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint Luc
        • Contact:
          • Jean-Francois Baurain, Site 0072
          • Phone Number: 3227645471
      • Charleroi, Belgium, 6000
        • Recruiting
        • Grand Hôpital de Charleroi-Oncology & Hematology
        • Contact:
          • Christophe Lonchay, Site 0078
          • Phone Number: +32 71 10 47 33
      • Jette, Belgium, 1090
        • Withdrawn
        • Local Institution - 0036
      • Liege, Belgium, 4000
        • Recruiting
        • CHU de Liège
        • Contact:
          • Andree Rorive, Site 0016
          • Phone Number: 3242844454
  • Brazil
      • Rio De Janeiro, Brazil, 20220-410
        • Recruiting
        • INCA- Instituto Nacional de Cancer Jose de Alencar Gomes da Silva
        • Contact:
          • Andreia De Melo, Site 0110
          • Phone Number: 552132076507
      • Sao Paulo, Brazil, 01321-001
        • Not yet recruiting
        • Local Institution - 0130
        • Contact:
          • Site 0130
    • Ce
      • Fortaleza, Ce, Brazil, 60130241
        • Not yet recruiting
        • Local Institution - 0177
        • Contact:
          • Site 0177
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-090
        • Recruiting
        • Oncologia de Preciso e Personalizada
        • Contact:
          • Alberto Julius Alves Wainstein, Site 0107
          • Phone Number: 553130474652
    • Parana
      • Curitiba, Parana, Brazil, 80520-174
        • Withdrawn
        • Local Institution - 0147
    • RIO Grande DO SUL
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
        • Recruiting
        • UPCO - Hospital de Clinicas de Porto Alegre
        • Contact:
          • Sergio De Azevedo, Site 0031
          • Phone Number: 555133598619
      • Porto Alegrelegre, RIO Grande DO SUL, Brazil, 91350-250
        • Recruiting
        • Hospital Nossa Senhora da Conceicao
        • Contact:
          • Juliana Menezes, Site 0002
    • Rio Grande Do Sul
      • Ijui, Rio Grande Do Sul, Brazil, 98700-000
        • Recruiting
        • ONCOSITE -Centro de Pesquisa Clinica em Oncologia Ltda
        • Contact:
          • Fabio Franke, Site 0025
          • Phone Number: +5555991592101
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • Recruiting
        • Hosptial Sao Lucas da PUC de Porto Alegre
        • Contact:
          • Fernanda Damian, Site 0058
          • Phone Number: 555133203039
    • SC
      • Blumenau, SC, Brazil, 89010-340
        • Recruiting
        • Clínica de Oncologia Reichow
        • Contact:
          • Sandro Reichow, Site 0159
          • Phone Number: 554733805890
    • Salvador-BA
      • Ondina, Salvador-BA, Brazil, 40170-110
        • Not yet recruiting
        • Local Institution - 0179
        • Contact:
          • Site 0179
    • Santa Catarina
      • Florianopolis, Santa Catarina, Brazil, 88034-000
        • Withdrawn
        • Local Institution - 0132
      • Lages, Santa Catarina, Brazil, 88501-003
        • Not yet recruiting
        • Local Institution - 0182
        • Contact:
          • Site 0182
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14784-400
        • Recruiting
        • Hospital do Amor de Barretos
        • Contact:
          • Fernanda Hassan, Site 0009
          • Phone Number: 551733216637
      • Sao Jose do Rio Preto, Sao Paulo, Brazil, 15090-000
        • Recruiting
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto
        • Contact:
          • Joao Daniel Cardoso Guedes, Site 0018
          • Phone Number: 551732015054
    • Vitoria
      • Santa Cecilia, Vitoria, Brazil, 29043-260
        • Not yet recruiting
        • Local Institution - 0180
        • Contact:
          • Site 0180
  • Canada
      • Quebec, Canada, G1J 1Z4
        • Recruiting
        • Hopital de l Enfant Jesus
        • Contact:
          • Felix Couture, Site 0103
          • Phone Number: 14186915383
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Recruiting
        • Tom Baker Cancer Centre (TBCC) - Alberta Health Services (AHS)
        • Contact:
          • Jose Monzon, Site 0141
          • Phone Number: 14035213688
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Recruiting
        • Juravinski Cancer Centre
        • Contact:
          • Elaine Mcwhirter, Site 0121
          • Phone Number: 19053879495
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • Ottawa Hospital Research Institute
        • Contact:
          • Xinni Song, Site 0096
          • Phone Number: 6137377700
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
          • Teresa Petrella, Site 0116
          • Phone Number: 4164805248
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4800827
        • Recruiting
        • James Lind Centro de Investigacion del Cancer
        • Contact:
          • Patricio Yanez Weber, Site 0143
    • Los Lagos
      • Puerto Montt, Los Lagos, Chile, 5500656
        • Not yet recruiting
        • Local Institution - 0178
        • Contact:
          • Site 0178
    • Metropolitana
      • Recoleta, Metropolitana, Chile, 8380455
        • Recruiting
        • Bradford Hill Centro de Investigacion Clnica
        • Contact:
          • Carlos Rojas Garcia, Site 0140
          • Phone Number: 56229490970
      • Santiago, Metropolitana, Chile, 7500921
        • Recruiting
        • Fundacion Arturo Lopez Perez
        • Contact:
          • Christian Caglevic, Site 0017
          • Phone Number: 56224457254
      • Santiago, Metropolitana, Chile, 7510032
        • Recruiting
        • Local Institution - 0010
        • Contact:
          • Site 0010
      • Santiago, Metropolitana, Chile, 0101010
        • Recruiting
        • Clinica San Carlos de Apoquindo
        • Contact:
          • Sebastian Mondaca, Site 0144
      • Santiago, Metropolitana, Chile, 8150513
        • Recruiting
        • Clinica Vespucio
        • Contact:
          • Paola Celedon, Site 0074
          • Phone Number: 56232100060
      • Vitacura, Metropolitana, Chile, JC5G 2Q
        • Withdrawn
        • Local Institution - 0142
    • Providencia
      • Santiago de Chile, Providencia, Chile, 7500653
        • Recruiting
        • Local Institution - 0119
        • Contact:
          • Site 0119
    • Valparaiso
      • Vina Del Mar, Valparaiso, Chile, 2520598
        • Recruiting
        • Oncocentro APYS
        • Contact:
          • Alenjandro Andres Acevedo Gaete, Site 0028
          • Phone Number: 5632332059
    • Valparaso
      • Via Del Mar, Valparaso, Chile, 254-0488
        • Not yet recruiting
        • Local Institution - 0176
        • Contact:
          • Site 0176
  • Colombia
      • Bogota, Colombia, 111511
        • Withdrawn
        • Local Institution - 0152
      • Medellin, Colombia, 50030
        • Withdrawn
        • Local Institution - 0149
      • Valledupar, Colombia, 200005
        • Withdrawn
        • Local Institution - 0150
  • Czechia
      • Hradec Kralove, Czechia, 500 05
        • Recruiting
        • University Hospital Hradec Kralove
        • Contact:
          • Jindrich Kopecky, Site 0094
          • Phone Number: +420495832176
      • Olomouc, Czechia, 77900
        • Recruiting
        • Fakultni nemocnice Olomouc FNOL
        • Contact:
          • Bohuslav Melichar, Site 0091
          • Phone Number: 420588444288
      • Ostrava Poruba, Czechia, 708 52
        • Recruiting
        • FN Ostrava
        • Contact:
          • Yvetta Vantuchova, Site 0082
          • Phone Number: 00420 597374573
      • Prague, Czechia, 182 00
        • Recruiting
        • Fakultni Nemocnice Kralovske Vinohrady FNKV
        • Contact:
          • Monika Arenbergerova, Site 0095
          • Phone Number: +420267162633
    • NY
      • Prague, NY, Czechia, 128 00
        • Recruiting
        • Univerzita Karlova v Praze a Vseobecna fakultni nemocnice v Praze
        • Contact:
          • Ivana Krajsova, Site 0083
          • Phone Number: +420224962426
  • Finland
      • Helsinki, Finland, 00029
        • Recruiting
        • Helsinki University Hospital HUS
        • Contact:
          • Micaela Hernberg, Site 0164
          • Phone Number: 358504279490
      • Tampere, Finland, 33521
        • Recruiting
        • Pirkanmaan Sairaanhoitopiiri - Tampereen Yliopistollinen Sairaala Tampere University Hospital - Keskussairaala
        • Contact:
          • Tanja Skytta, Site 0167
          • Phone Number: +358331163203
      • Turku, Finland, 20520
        • Recruiting
        • Turku University Hospital
        • Contact:
          • Kalle Mattila, Site 0162
          • Phone Number: +35823130729
  • France
      • Amiens, France, 80054
        • Recruiting
        • CHU Amiens-Picardie - Site Nord
        • Contact:
          • Jean-Philippe Arnault, Site 0007
          • Phone Number: 33322455843
      • Bayonne, France, 64100
        • Recruiting
        • Centre Hospitalier de la Côte Basque
        • Contact:
          • Suzanne Devaux, Site 0128
          • Phone Number: 330559443780
      • Bordeaux, France, 33000
        • Recruiting
        • CHU de Bordeaux - Hopital Saint-Andre
        • Contact:
          • Caroline Dutriaux, Site 0022
          • Phone Number: +33556794964
      • Clermont Ferrand Cedex 1, France, 63003
        • Recruiting
        • Centre Hospitalier Universitaire de Clermont Ferrand
        • Contact:
          • Sandrine Mansard, Site 0129
          • Phone Number: +33473750550
      • Dijon, France, 21079
        • Recruiting
        • CHU Dijon - Hopital Francois Mitterand
        • Contact:
          • Sophie Dalac Rat, Site 0046
          • Phone Number: 33333380293336
      • Marseille, France, 13385
        • Recruiting
        • Local Institution - 0117
        • Contact:
          • Site 0117
      • Marseille, France, 13385
        • Not yet recruiting
        • Local Institution - 0190
        • Contact:
          • Site 0190
      • Pierre-Benite, France, 69310
        • Recruiting
        • Hopital Lyon Sud
        • Contact:
          • Stephane Dalle, Site 0052
          • Phone Number: 33478861679
      • Rennes Cedex, France, 35042
        • Recruiting
        • Centre Eugène Marquis
        • Contact:
          • Marc Pracht, Site 0089
          • Phone Number: 33299253196
      • Rouen, France, 76031
        • Recruiting
        • CHU de Rouen - Hôpital Charles Nicolle
        • Contact:
          • Anne-Benedicte Duval Modeste, Site 0099
          • Phone Number: +33232886841
      • Saint Etienne, France, 42055
        • Withdrawn
        • Local Institution - 0181
    • Cedex 9
      • Toulouse, Cedex 9, France, 31059
        • Recruiting
        • Institut Claudius Regaud IUCT O
        • Contact:
          • Cecile Pages Laurent, Site 0108
          • Phone Number: 33531155675
    • Ile De France
      • Paris, Ile De France, France, 75475
        • Recruiting
        • Hôpital Saint-Louis
        • Contact:
          • Celeste Lebbe, Site 0034
          • Phone Number: +33142494679 0 0000
    • Indre-Et-Loire
      • Chambray-les-Tours, Indre-Et-Loire, France, 37044
        • Recruiting
        • Local Institution - 0127
        • Contact:
          • Site 0127
    • Nord
      • Lille, Nord, France, 59000
        • Recruiting
        • CHU Lille - Hopital Huriez
        • Contact:
          • Laurent MORTIER, Site 0111
          • Phone Number: 33320444193
    • OH
      • Nantes Cedex 01, OH, France, 44093
        • Recruiting
        • Hotel Dieu CHU Nantes
        • Contact:
          • Gaelle Quereux, Site 0063
          • Phone Number: 02 40 08 31 44
    • Val-De-Marne
      • Villejuif Cedex, Val-De-Marne, France, 94805
        • Recruiting
        • Institut Gustave Roussy
        • Contact:
          • Caroline Robert, Site 0061
          • Phone Number: 33142114210
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charite Universitaetsmedizin Berlin
        • Contact:
          • Thomas Eigentler, Site 0060
          • Phone Number: +4930450518002
      • Dortmund, Germany, 44137
        • Not yet recruiting
        • Local Institution - 0136
        • Contact:
          • Site 0136
      • Erfurt, Germany, 99089
        • Recruiting
        • Local Institution - 0039
        • Contact:
          • Site 0039
      • Essen, Germany, 45147
        • Recruiting
        • Universitaetsklinikum Essen, Klinik fuer Dermatologie
        • Contact:
          • Dirk Schadendorf, Site 0049
          • Phone Number: 492017232431
      • Frankfurt, Germany, 60590
        • Recruiting
        • Universitaetsklinikum Frankfurt Main
        • Contact:
          • Roland Kaufmann, Site 0166
          • Phone Number: +00496963015311 000
      • Giessen, Germany, 35385
        • Recruiting
        • Department of Dermatology, University hospital Giessen
        • Contact:
          • Daniela Goeppner, Site 0065
          • Phone Number: 49+49641985
      • Goettingen, Germany, 37075
        • Recruiting
        • Local Institution - 0135
        • Contact:
          • Site 0135
      • Hamburg, Germany, 20251
        • Recruiting
        • Universitaetsklinikum Hamburg Eppendorf - UKE, Dept of Dermatology (W14)
        • Contact:
          • Christoffer Gebhardt, Site 0138
          • Phone Number: 004915222873742
      • Koeln, Germany, 50937
        • Withdrawn
        • Local Institution - 0148
      • Ludwigshafen, Germany, 67063
        • Recruiting
        • Local Institution - 0137
        • Contact:
          • Site 0137
      • Marburg, Germany, 35043
        • Recruiting
        • Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Dermatologie Venerologie und Allergologie - Standort Marburg
        • Contact:
          • Martin Gschnell, Site 0165
          • Phone Number: 4964215869115
      • Minden, Germany, 32429
        • Recruiting
        • Johannes Wesling Medical Center Minden
        • Contact:
          • Ralf Gutzmer, Site 0044
          • Phone Number: 495717094501
      • Munchen, Germany, 80337
        • Withdrawn
        • Local Institution - 0076
      • Nuernberg, Germany, 90419
        • Recruiting
        • Studienambulanz Hautklinik Klinikum Nuernberg
        • Contact:
          • Dirk Debus, Site 0112
          • Phone Number: 499113982044
      • Rostock, Germany, 18057
        • Recruiting
        • Unviersitaetsmedizin Rostock
        • Contact:
          • Julia Tietze, Site 0053
          • Phone Number: +498951606325
      • Tuebingen, Germany, 72076
        • Recruiting
        • Studienzentrum Hautklinik Tuebingen
        • Contact:
          • Teresa Amaral, Site 0081
          • Phone Number: +4970712984555
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Recruiting
        • Nationales Centrum fr Tumorerkrankungen NCT
        • Contact:
          • Jessica Hassel, Site 0101
          • Phone Number: 06221-5638503
    • Baden-Württemberg
      • Ulm, Baden-Württemberg, Germany, 89081
        • Recruiting
        • Universitaetsklinikum Ulm
        • Contact:
          • Anca Sindrilaru, Site 0079
          • Phone Number: 4973150057602
    • Bayern
      • Regensburg, Bayern, Germany, 93042
        • Recruiting
        • Universittsklinikum Regensburg
        • Contact:
          • Sebastian Haferkamp, Site 0011
          • Phone Number: 499419449605
    • Niedersachsen
      • Buxtehude, Niedersachsen, Germany, 21614
        • Recruiting
        • Elbe Klinikum Buxtehude
        • Contact:
          • Peter Mohr, Site 0038
          • Phone Number: +4941617036207
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Germany, 23538
        • Recruiting
        • Universitaetsklinikum Schleswig-Holstein
        • Contact:
          • Patrick Terheyden, Site 0003
          • Phone Number: 4945150041510
  • Israel
      • Afula, Israel, 1834111
        • Recruiting
        • Emek Medical Center
        • Contact:
          • Gil Bar-Sela, Site 0026
          • Phone Number: 97246495723
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Local Institution - 0054
        • Contact:
          • Site 0054
      • Petah-Tikvah, Israel, 4941492
        • Not yet recruiting
        • Local Institution - 0102
        • Contact:
          • Site 0102
      • Tel Hashomer, Israel, 5262100
        • Recruiting
        • Local Institution - 0035
        • Contact:
          • Site 0035
      • Tel-Aviv, Israel, 6423906
        • Recruiting
        • Tel-Aviv Sourasky Medical Center
        • Contact:
          • Mor Miodovnik, Site 0173
          • Phone Number: 9720522783911
  • Italy
      • Bari, Italy, 70124
        • Recruiting
        • Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
        • Contact:
          • Michele Guida, Site 0051
          • Phone Number: +39 0805555138
      • Genova, Italy, 16132
        • Recruiting
        • IRCCS Ospedale Policlinico San Martino
        • Contact:
          • Francesco Spagnolo, Site 0077
          • Phone Number: 390105558901
      • Napoli, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori - Fondazione Pascale Italy
        • Contact:
          • Paolo Ascierto, Site 0084
          • Phone Number: 390815903431
      • Perugia, Italy, 06132
        • Recruiting
        • Ospedale S. Maria Della Misericordia
        • Contact:
          • Mario Mandala, Site 0032
          • Phone Number: 39 0755287080
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
          • Giovanni Schinzari, Site 0064
          • Phone Number: 390039630156733
      • Siena, Italy, 53100
        • Recruiting
        • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
        • Contact:
          • Michele Maio, Site 0014
          • Phone Number: 390577586335
    • Milan
      • Milano, Milan, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori
        • Contact:
          • Michele Del Vecchio, Site 0170
  • Mexico
      • Puebla, Mexico, 72424
        • Not yet recruiting
        • Local Institution - 0131
        • Contact:
          • Site 0131
      • Queretaro, Mexico, 76000
        • Not yet recruiting
        • Local Institution - 0073
        • Contact:
          • Site 0073
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45070
        • Not yet recruiting
        • Local Institution - 0001
        • Contact:
          • Site 0001
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Not yet recruiting
        • Local Institution - 0104
        • Contact:
          • Site 0104
    • Oaxaca
      • Ciudad de Mexico, Oaxaca, Mexico, 03100
        • Not yet recruiting
        • Local Institution - 0075
        • Contact:
          • Site 0075
    • Quintana Roo
      • Cancun, Quintana Roo, Mexico, 77506
        • Not yet recruiting
        • Local Institution - 0174
        • Contact:
          • Site 0174
  • Norway
      • Bodo, Norway, 8005
        • Not yet recruiting
        • Local Institution - 0163
        • Contact:
          • Site 0163
      • Gralum, Norway, 1714
        • Recruiting
        • Sykehuset Ostfold Kalnes
        • Contact:
          • Oyvind Krohn Tennoe, Site 0156
          • Phone Number: +4769860000
      • Lørenskog, Norway, 1474
        • Recruiting
        • Akershus University Hospital
        • Contact:
          • Martin Ruppert, Site 0158
          • Phone Number: 4767960000
      • Oslo, Norway, 0379
        • Not yet recruiting
        • Local Institution - 0155
        • Contact:
          • Site 0155
  • Poland
      • Bialystok, Poland, 15-027
        • Not yet recruiting
        • Local Institution - 0187
        • Contact:
          • Site 0187
      • Gliwice, Poland, 44-102
        • Not yet recruiting
        • Local Institution - 0185
        • Contact:
          • Site 0185
      • Warszawa, Poland, 02-781
        • Recruiting
        • Maria Sklodowska-Curie National Research Institute of Oncology
        • Contact:
          • Piotr Rutkowski, Site 0066
          • Phone Number: 48226439375
      • Wroclaw, Poland, 53-413
        • Withdrawn
        • Local Institution - 0048
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
        • Recruiting
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka
        • Contact:
          • Bogdan Zurawski, Site 0171
          • Phone Number: +48501446778
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30727
        • Recruiting
        • Pratia McM Kraków
        • Contact:
          • Bozena Cybulska-Stopa, Site 0021
          • Phone Number: +48126348232
    • Opolskie
      • Opole, Opolskie, Poland, 45-061
        • Recruiting
        • SPZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego
        • Contact:
          • Barbara Radecka, Site 0005
          • Phone Number: 48502313767
    • Wiekopolskie
      • Poznan, Wiekopolskie, Poland, 60-780
        • Recruiting
        • Poznan University of Medical Sciences
        • Contact:
          • Jacek Mackiewicz, Site 0015
          • Phone Number: 48606228277
  • Spain
      • Badalona, Spain, 08916
        • Recruiting
        • Local Institution - 0134
        • Contact:
          • Site 0134
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic De Barcelona
        • Contact:
          • Ana Arance Fernandez, Site 0024
          • Phone Number: 34932275402
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Valle de Hebrón
        • Contact:
          • Eva Munoz Couselo, Site 0047
          • Phone Number: 349327460004350
      • Granada, Spain, 18016
        • Not yet recruiting
        • Local Institution - 0188
        • Contact:
          • Site 0188
      • Jaen, Spain, 23007
        • Recruiting
        • Complejo Hospitalario de Jaén
        • Contact:
          • Pedro Lopez Leiva, Site 0153
          • Phone Number: 3434+34955018000
      • Las Palmas de Gran Canaria, Spain, 35016
        • Recruiting
        • Complejo Hospitalario Materno-Insular - Hospital Insular de Gran Canaria
        • Contact:
          • Delvys Rodriguez Abreu, Site 0045
          • Phone Number: 3434928441738
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Guillermo De Velasco Oria de Rueda, Site 0004
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
          • Ivan Marquez Rodas, Site 0040
          • Phone Number: 34914269394
      • Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario HM Sanchinarro
        • Contact:
          • Juan Francisco Rodriguez Moreno, Site 0056
          • Phone Number: +34917567984
      • Madrid, Spain, 28009
        • Recruiting
        • Local Institution - 0126
        • Contact:
          • Site 0126
      • Sevilla, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
          • Luis de la Cruz Merino, Site 0006
          • Phone Number: 34600162731
      • Valencia, Spain, 46014
        • Recruiting
        • Hospital General Universitario de Valencia
        • Contact:
          • Alfonso Berrocal Jaime, Site 0151
          • Phone Number: 34963131800437635
      • Valencia, Spain, 46009
        • Recruiting
        • Hospital Universitario La Fe Hospital La Fe Campanar
        • Contact:
          • Roberto Pedro Diaz Beveridge, Site 0043
          • Phone Number: 34961244193
      • Valencia, Spain, 46009
        • Recruiting
        • Fundacin Instituto Valenciano de Oncologa
        • Contact:
          • Maria Jose Juan-Fita, Site 0041
          • Phone Number: 34961114000
      • Zaragoza, Spain, 50009
        • Not yet recruiting
        • Local Institution - 0186
        • Contact:
          • Site 0186
    • A Coruña
      • A Coruna, A Coruña, Spain, 15006
        • Recruiting
        • CH Universitario de A Coruñas
        • Contact:
          • Maria Quindos Varela, Site 0086
          • Phone Number: 34981178000
    • Gipuzkoa
      • Donostia, Gipuzkoa, Spain, 20014
        • Recruiting
        • Onkologikoa Of San Sebastian
        • Contact:
          • Miren Karmele Mujika Eizmendi, Site 0012
          • Phone Number: 34943328315
  • Sweden
      • Lund, Sweden, 222 42
        • Recruiting
        • Skne University Hospital Lund
        • Contact:
          • Bjorn Batshake, Site 0097
          • Phone Number: 46707666001
      • Uppsala, Sweden, 751 85
        • Withdrawn
        • Local Institution - 0069
    • Stockholm
      • Solna, Stockholm, Sweden, 171 64
        • Recruiting
        • Karolinska Universitetssjukhuset - Solna
        • Contact:
          • Hildur Helgadottir, Site 0062
          • Phone Number: 460851770000
    • Vastergotland
      • Linkoeping, Vastergotland, Sweden, 58185
        • Withdrawn
        • Local Institution - 0157
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital Bern
        • Contact:
          • Berna Oezdemir, Site 0092
          • Phone Number: 41316324114
      • Chur, Switzerland, 7000
        • Recruiting
        • Kantonsspital Graubuenden
        • Contact:
          • Roger Von Moos, Site 0080
          • Phone Number: 41812566647
      • Lausanne, Switzerland, 1011
        • Recruiting
        • UNIL-CHUV Lausanne
        • Contact:
          • Sofiya Latifyan, Site 0105
          • Phone Number: 41795562698
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, SE1 9RT
        • Withdrawn
        • Local Institution - 0085
      • London, Greater London, United Kingdom, SW3 6JJ
        • Recruiting
        • The Royal Marsden NHS Foundation Trust
        • Contact:
          • James Larkin, Site 0088
          • Phone Number: 442078082132
    • Oxfordshire
      • Headington, Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Not yet recruiting
        • Local Institution - 0068
        • Contact:
          • Site 0068
    • Strathclyde
      • Glasgow, Strathclyde, United Kingdom, G12 0YN
        • Withdrawn
        • Local Institution - 0087
    • Tyne And Wear
      • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
        • Recruiting
        • Northern Centre for Cancer Care
        • Contact:
          • Elizabeth Plummer, Site 0120
          • Phone Number: 441912138476
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • Dignity Health - St. Josephs Hospital and Medical Center
        • Contact:
          • Miguel Gonzalez Velez, Site 0125
    • Arkansas
      • Springdale, Arkansas, United States, 73762
        • Not yet recruiting
        • Local Institution - 0189
        • Contact:
          • Site 0189
    • California
      • Los Angeles, California, United States, 90025
        • Recruiting
        • The Angeles Clinic and Research Institute
        • Contact:
          • Inderjit Mehmi, Site 0098
          • Phone Number: 310-231-2153
      • Orange, California, United States, 92868-3201
        • Recruiting
        • UC Irvine Health
        • Contact:
          • Warren Chow, Site 0093
          • Phone Number: 714-456-3905
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford Univ Med School Dept of Dermatology
        • Contact:
          • Sunil Reddy, Site 0123
          • Phone Number: 650-743-4516
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Recruiting
        • The Melanoma and Skin Cancer Institute
        • Contact:
          • Ryan Weight, Site 0113
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic - Jacksonville
        • Contact:
          • Roxana Dronca, Site 0114
          • Phone Number: 507-284-2511
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Withdrawn
        • Ft. Wayne Medical Oncology and Hematology
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Greenebaum Cancer Center University of Maryland
        • Contact:
          • Petr Hausner, Site 0146
          • Phone Number: 410-328-6896
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Svetomir Markovic, Site 0071
          • Phone Number: 507-284-2511
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Oncology Hematology West P.C. Nebraska Cancer Specialist
        • Contact:
          • Ralph Hauke, Site 0013
          • Phone Number: 402-334-4773
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Withdrawn
        • Rutgers CINJ
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Cleveland Clinic
        • Contact:
          • Brian Gastman, Site 0169
          • Phone Number: 216-444-2501
    • Pennsylvania
      • Easton, Pennsylvania, United States, 18045
        • Recruiting
        • St. Lukes University Health Network
        • Contact:
          • Melissa Wilson, Site 0139
          • Phone Number: 212-731-6160
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Contact:
          • Rino Seedor, Site 0124
          • Phone Number: 215-955-9980
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center Campus Location
        • Contact:
          • Caroline Nebhan, Site 0122
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Health Care Services
        • Contact:
          • Sekwon Jang, Site 0115
          • Phone Number: 202-615-8535

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to < 18 years of age).
  • Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system.
  • Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
  • Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and < 18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed consent (assent).
  • Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition).

Exclusion Criteria

  • Participants must not have ocular melanoma.
  • Participants must not have a history of myocarditis, regardless of etiology.
  • Participants must not have a condition requiring systemic treatment with either corticosteroids (>10 milligrams [mg] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nivolumab + Relatlimab FDC SC
Drug: rHuPH20
Specified dose on specified days
Drug: Nivolumab + Relatlimab
Specified dose on specified days
Other Names:
  • BMS-986213
  • Opdualag
Active Comparator: Nivolumab + Relatlimab FDC IV
Drug: Nivolumab + Relatlimab
Specified dose on specified days
Other Names:
  • BMS-986213
  • Opdualag

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time-averaged serum concentration over 28 days after the first dose (Cavgd28) of Nivolumab
Time Frame: Up to 28 days
Up to 28 days
Trough serum concentration at steady state (Cminss) of Nivolumab
Time Frame: Up to 4 months
Up to 4 months
Cavgd28 of Relatlimab
Time Frame: Up to 28 days
Up to 28 days
Cminss of Relatlimab
Time Frame: Up to 4 months
Up to 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) per RECIST v1.1
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Trough serum concentration at Day 28 after the first dose (Cmind28) of Nivolumab and Relatlimab
Time Frame: Up to 28 days
Up to 28 days
Peak serum concentration after the first dose (Cmax1) of Nivolumab and Relatlimab
Time Frame: Up to 28 days
Up to 28 days
Time to Cmax1 (Tmax1) of Nivolumab and Relatlimab
Time Frame: Up to 28 days
Up to 28 days
Peak serum concentration at steady state (Cmaxss) of Nivolumab and Relatlimab
Time Frame: Up to 4 months
Up to 4 months
Time-averaged serum concentration at steady state (Cavgss) of Nivolumab and Relatlimab
Time Frame: Up to 4 months
Up to 4 months
Duration of Response (DOR) by BICR per RECIST v1.1
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Disease Control Rate (DCR) by BICR per RECIST v1.1
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Time to Response (TTR), by BICR per RECIST v1.1
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Objective Response Rate (ORR) by Investigator per RECIST v1.1
Time Frame: Up to approximately 3 years
Up to approximately 3 years
DOR by Investigator per RECIST v1.1
Time Frame: Up to approximately 3 years
Up to approximately 3 years
DCR by Investigator per RECIST v1.1
Time Frame: Up to approximately 3 years
Up to approximately 3 years
TTR by Investigator per RECIST v1.1
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Progression Free Survival (PFS) by BICR and Investigator per RECIST v1.1
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Overall Survival
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Number of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Change from Baseline in Functional Assessment of Cancer Therapy - Melanoma Subscale (FACT-MS)
Time Frame: Up to approximately 3 years
Up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2023

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

November 15, 2022

First Submitted That Met QC Criteria

November 15, 2022

First Posted (Actual)

November 22, 2022

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA224-127
  • 2022-000575-39 (EudraCT Number)
  • U1111-1274-0193 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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