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Um estudo da combinação de dose fixa subcutânea de Nivolumab + Relatlimab (FDC) em melanoma metastático ou irressecável não tratado anteriormente (RELATIVITY-127)

3 de agosto de 2026 atualizado por: Bristol-Myers Squibb

Um estudo de fase 3, randomizado, aberto, da combinação subcutânea de nivolumab + relalimab em dose fixa versus combinação intravenosa de nivolumab + relalimab em dose fixa em participantes com melanoma metastático ou irressecável não tratado anteriormente

O objetivo deste estudo é demonstrar que o nível de exposição ao medicamento do estudo da formulação subcutânea (SC) de nivolumab + relatlimab FDC não é pior do que a administração intravenosa (IV) de nivolumab + relatlimab FDC em participantes com melanoma metastático ou irressecável não tratado anteriormente.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

579

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Berlin, Alemanha, 10117
        • Local Institution - 0060
      • Buxtehude, Alemanha, 21614
        • Local Institution - 0038
      • Dortmund, Alemanha, 44137
        • Local Institution - 0136
      • Erfurt, Alemanha, 99089
        • Local Institution - 0039
      • Essen, Alemanha, 45147
        • Local Institution - 0049
      • Frankfurt am Main, Alemanha, 60590
        • Local Institution - 0166
      • Giessen, Alemanha, 35385
        • Local Institution - 0065
      • Göttingen, Alemanha, 37075
        • Local Institution - 0135
      • Hamburg, Alemanha, 20251
        • Local Institution - 0138
      • Ludwigshafen, Alemanha, 67063
        • Local Institution - 0137
      • Marburg, Alemanha, 35043
        • Local Institution - 0165
      • Minden, Alemanha, 32429
        • Local Institution - 0044
      • Nuremberg, Alemanha, 90419
        • Local Institution - 0112
      • Rostock, Alemanha, 18057
        • Local Institution - 0053
      • Tübingen, Alemanha, 72076
        • Local Institution - 0081
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Alemanha, 69120
        • Local Institution - 0101
      • Ulm, Baden-Wurttemberg, Alemanha, 89081
        • Local Institution - 0079
    • Bavaria
      • Regensburg, Bavaria, Alemanha, 93042
        • Local Institution - 0011
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Alemanha, 23538
        • Local Institution - 0003
  • Austrália
    • New South Wales
      • Coffs Harbour, New South Wales, Austrália, 2450
        • Local Institution - 0050
      • Orange, New South Wales, Austrália, 2800
        • Local Institution - 0175
      • Port Macquarie, New South Wales, Austrália, 2444
        • Local Institution - 0172
      • Wagga Wagga, New South Wales, Austrália, 2650
        • Local Institution - 0118
      • Waratah, New South Wales, Austrália, 2298
        • Local Institution - 0184
      • Westmead, New South Wales, Austrália, 2145
        • Local Institution - 0033
      • Wollstonecraft, New South Wales, Austrália, 2065
        • Local Institution - 0055
    • Queensland
      • Birtinya, Queensland, Austrália, 4575
        • Local Institution - 0090
    • Victoria
      • Bendigo, Victoria, Austrália, 3550
        • Local Institution - 0008
      • Box Hill, Victoria, Austrália, 3128
        • Local Institution - 0059
      • Heidelberg, Victoria, Austrália, 3084
        • Local Institution - 0154
      • Melbourne, Victoria, Austrália, 3004
        • Local Institution - 0030
      • Traralgon, Victoria, Austrália, 3844
        • Local Institution - 0109
    • Western Australia
      • Nedlands, Western Australia, Austrália, 6009
        • Local Institution - 0106
      • Nedlands, Western Australia, Austrália, 6009
        • Local Institution - 0161
  • Brasil
    • Ceará
      • Fortaleza, Ceará, Brasil, 60135237
        • Local Institution - 0177
    • Espírito Santo
      • Vitória, Espírito Santo, Brasil, 29043-260
        • Local Institution - 0180
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasil, 30130-090
        • Local Institution - 0107
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brasil, 98700-000
        • Local Institution - 0025
      • Porto Alegre, Rio Grande do Sul, Brasil, 90035-903
        • Local Institution - 0031
      • Porto Alegre, Rio Grande do Sul, Brasil, 90610-000
        • Local Institution - 0058
      • Porto Alegrelegre, Rio Grande do Sul, Brasil, 91350-250
        • Local Institution - 0002
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brasil, 20220-410
        • Local Institution - 0110
    • Santa Catarina
      • Blumenau, Santa Catarina, Brasil, 89010-340
        • Local Institution - 0159
    • São Paulo
      • Barretos, São Paulo, Brasil, 14784-400
        • Local Institution - 0009
      • São José do Rio Preto, São Paulo, Brasil, 15090-000
        • Local Institution - 0018
      • São Paulo, São Paulo, Brasil, 01321-001
        • Local Institution - 0130
  • Bélgica
      • Brussels, Bélgica, 1200
        • Local Institution - 0072
      • Charleroi, Bélgica, 6000
        • Local Institution - 0078
      • Liège, Bélgica, 4000
        • Local Institution - 0016
  • Canadá
    • Alberta
      • Calgary, Alberta, Canadá, T2N 5G2
        • Local Institution - 0141
    • Ontario
      • Hamilton, Ontario, Canadá, L8V 5C2
        • Local Institution - 0121
      • Ottawa, Ontario, Canadá, K1H 8L6
        • Local Institution - 0096
      • Toronto, Ontario, Canadá, M4N 3M5
        • Local Institution - 0116
    • Quebec
      • Québec, Quebec, Canadá, G1J 1Z4
        • Local Institution - 0103
  • Chile
      • Santiago, Chile, 7500921
        • Local Institution - 0017
    • Araucania
      • Temuco, Araucania, Chile, 4800827
        • Local Institution - 0143
    • Los Lagos Region
      • Port Montt, Los Lagos Region, Chile, 5507642
        • Local Institution - 0178
    • Providencia
      • Santiago, Providencia, Chile, 7500653
        • Local Institution - 0119
    • Santiago Metropolitan
      • Recoleta, Santiago Metropolitan, Chile, 8380455
        • Local Institution - 0140
      • Santiago, Santiago Metropolitan, Chile, 0101010
        • Local Institution - 0144
      • Santiago, Santiago Metropolitan, Chile, 7510032
        • Local Institution - 0010
      • Santiago, Santiago Metropolitan, Chile, 8150513
        • Local Institution - 0074
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Local Institution - 0028
  • Espanha
      • Badalona, Espanha, 08916
        • Local Institution - 0134
      • Barcelona, Espanha, 08036
        • Local Institution - 0024
      • Las Palmas de Gran Canaria, Espanha, 35016
        • Local Institution - 0045
      • Madrid, Espanha, 28007
        • Local Institution - 0040
      • Madrid, Espanha, 28050
        • Local Institution - 0056
      • Seville, Espanha, 41009
        • Local Institution - 0006
      • Valencia, Espanha, 46014
        • Local Institution - 0151
      • Valencia, Espanha, 46009
        • Local Institution - 0043
    • A Coruna
      • A Coruña, A Coruna, Espanha, 15006
        • Local Institution - 0086
    • Barcelona
      • Barcelona, Barcelona, Espanha, 08035
        • Local Institution - 0047
    • Gipuzkoa
      • Donostia / San Sebastian, Gipuzkoa, Espanha, 20014
        • Local Institution - 0012
    • Jaen
      • Jaén, Jaen, Espanha, 23007
        • Local Institution - 0153
    • Madrid
      • Madrid, Madrid, Espanha, 28009
        • Local Institution - 0126
      • Madrid, Madrid, Espanha, 28041
        • Local Institution - 0004
    • Valencia
      • Valencia, Valencia, Espanha, 46009
        • Local Institution - 0041
  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85013
        • Local Institution - 0125
    • Arkansas
      • Springdale, Arkansas, Estados Unidos, 72762
        • Local Institution - 0189
    • California
      • Los Angeles, California, Estados Unidos, 90025
        • Local Institution - 0098
      • Orange, California, Estados Unidos, 92868-3201
        • Local Institution - 0093
      • Stanford, California, Estados Unidos, 94305
        • Local Institution - 0123
    • Colorado
      • Englewood, Colorado, Estados Unidos, 80113
        • Local Institution - 0113
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32224
        • Local Institution - 0114
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21201
        • Local Institution - 0146
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
        • Local Institution - 0071
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68130
        • Local Institution - 0013
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44195
        • Local Institution - 0169
    • Pennsylvania
      • Easton, Pennsylvania, Estados Unidos, 18045
        • Local Institution - 0139
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • Local Institution - 0124
    • Utah
      • Murray, Utah, Estados Unidos, 84107
        • Local Institution - 0122
    • Virginia
      • Fairfax, Virginia, Estados Unidos, 22031
        • Local Institution - 0115
  • Finlândia
      • Helsinki, Finlândia, 00029
        • Local Institution - 0164
      • Tampere, Finlândia, 33521
        • Local Institution - 0167
      • Turku, Finlândia, 20520
        • Local Institution - 0162
  • França
      • Amiens, França, 80054
        • Local Institution - 0007
      • Bayonne, França, 64100
        • Local Institution - 0128
      • Bordeaux, França, 33000
        • Local Institution - 0022
      • Clermont-Ferrand, França, 63003
        • Local Institution - 0129
      • Dijon, França, 21079
        • Local Institution - 0046
      • Marseille, França, 13385
        • Local Institution - 0117
      • Pierre-Bénite, França, 69310
        • Local Institution - 0052
      • Rennes, França, 35042
        • Local Institution - 0089
      • Rouen, França, 76031
        • Local Institution - 0099
    • Cedex 9
      • Toulouse, Cedex 9, França, 31059
        • Local Institution - 0108
    • Indre-Et-Loire
      • Chambray-lès-Tours, Indre-Et-Loire, França, 37044
        • Local Institution - 0127
    • Nord
      • Lille, Nord, França, 59000
        • Local Institution - 0111
    • OH
      • Nantes, OH, França, 44093
        • Local Institution - 0063
    • Val-De-Marne
      • Villejuif, Val-De-Marne, França, 94805
        • Local Institution - 0061
    • Île-de-France Region
      • Paris, Île-de-France Region, França, 75475
        • Local Institution - 0034
  • Israel
      • Afula, Israel, 1834111
        • Local Institution - 0026
      • Petah-Tikvah, Israel, 4941492
        • Local Institution - 0102
      • Tel Aviv, Israel, 6423906
        • Local Institution - 0173
      • Tel Litwinsky, Israel, 5262100
        • Local Institution - 0035
    • Israel
      • Jerusalem, Israel, Israel, 9112001
        • Local Institution - 0054
  • Itália
      • Bari, Itália, 70124
        • Local Institution - 0051
      • Milan, Itália, 20133
        • Local Institution - 0170
      • Naples, Itália, 80131
        • Local Institution - 0084
      • Perugia, Itália, 06132
        • Local Institution - 0032
      • Roma, Itália, 00168
        • Local Institution - 0064
    • Genova
      • Genova, Genova, Itália, 16132
        • Local Institution - 0077
    • Siena
      • Siena, Siena, Itália, 53100
        • Local Institution - 0014
  • Noruega
      • Bodø, Noruega, 8005
        • Local Institution - 0163
      • Grålum, Noruega, 1714
        • Local Institution - 0156
      • Lørenskog, Noruega, 1474
        • Local Institution - 0158
      • Oslo, Noruega, 0379
        • Local Institution - 0155
  • Polônia
      • Warsaw, Polônia, 02-781
        • Local Institution - 0066
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polônia, 85-796
        • Local Institution - 0171
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Polônia, 30727
        • Local Institution - 0021
    • Opole Voivodeship
      • Opole, Opole Voivodeship, Polônia, 45-061
        • Local Institution - 0005
    • Wiekopolskie
      • Poznan, Wiekopolskie, Polônia, 60-780
        • Local Institution - 0015
  • Reino Unido
    • Greater London
      • London, Greater London, Reino Unido, SW3 6JJ
        • Local Institution - 0088
    • Oxfordshire
      • Headington, Oxford, Oxfordshire, Reino Unido, OX3 7LE
        • Local Institution - 0068
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, Reino Unido, NE7 7DN
        • Local Institution - 0120
  • Suécia
      • Lund, Suécia, 222 42
        • Local Institution - 0097
    • Stockholm County
      • Solna, Stockholm County, Suécia, 171 64
        • Local Institution - 0062
  • Suíça
      • Bern, Suíça, 3010
        • Local Institution - 0092
      • Chur, Suíça, 7000
        • Local Institution - 0080
      • Lausanne, Suíça, 1011
        • Local Institution - 0105
  • Tcheca
      • Hradec Králové, Tcheca, 500 05
        • Local Institution - 0094
      • Olomouc, Tcheca, 77900
        • Local Institution - 0091
      • Ostrava Poruba, Tcheca, 708 52
        • Local Institution - 0082
      • Prague, Tcheca, 182 00
        • Local Institution - 0095
    • NY
      • Prague, NY, Tcheca, 128 00
        • Local Institution - 0083
  • Áustria
      • Graz, Áustria, 8036
        • Local Institution - 0027
      • Salzburg, Áustria, 5020
        • Local Institution - 0029
      • Sankt Pölten, Áustria, 3100
        • Local Institution - 0168
      • Vienna, Áustria, 1090
        • Local Institution - 0037

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

12 anos e mais velhos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • Os participantes devem ter um status de desempenho do Eastern Cooperative Oncology Group (ECOG) ≤ 1/Lansky Performance Score ≥ 80% para adolescentes (≥ 12 a < 18 anos de idade).
  • Os participantes devem ter melanoma de estágio III (irressecável) ou estágio IV (metastático) confirmado histologicamente, de acordo com o sistema de estadiamento do American Joint Committee for Cancer (AJCC).
  • Os participantes devem ter doença mensurável por tomografia computadorizada (TC) ou ressonância magnética (MRI) de acordo com os Critérios de Avaliação de Resposta em Tumores Sólidos versão 1.1 (RECIST v1.1).
  • Os participantes devem ter ≥ 12 anos de idade. Participantes com idade ≥ 12 anos e < 18 anos (adolescentes) devem pesar ≥ 40 kg no momento da assinatura do consentimento informado (consentimento).
  • Os participantes devem ter melanoma de estágio III (irressecável) ou estágio IV (metastático) confirmado histologicamente, de acordo com o sistema de estadiamento AJCC (8ª edição).

Critério de exclusão:

  • Os participantes não devem ter melanoma ocular.
  • Os participantes não devem ter histórico de miocardite, independentemente da etiologia.
  • Os participantes não devem ter uma condição que requeira tratamento sistêmico com corticosteroides (>10 miligramas [mg] equivalentes diários de prednisona) ou outros medicamentos imunossupressores dentro de 14 dias do início do tratamento do estudo. Esteroides inalatórios ou tópicos e doses de esteroides de reposição adrenal >10 mg diários equivalentes à prednisona são permitidos na ausência de doença autoimune ativa.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Nivolumabe + Relatlimabe FDC SC
Medicamento: rHuPH20
Dose especificada em dias especificados
Medicamento: Nivolumabe + Relatlimabe
Dose especificada em dias especificados
Outros nomes:
  • BMS-986213
  • Opdulag
Comparador Ativo: Nivolumabe + Relatlimabe FDC IV
Medicamento: Nivolumabe + Relatlimabe
Dose especificada em dias especificados
Outros nomes:
  • BMS-986213
  • Opdulag

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Adjusted Time-Averaged Nivolumab Serum Concentration Over the First 28 Days (Cavgd28-Nivo) on Natural Logarithmic Scale
Prazo: Pre-dose (Day 1 to Day 28)
Blood samples were collected to assess serum concentration.
Pre-dose (Day 1 to Day 28)
Adjusted Time-Averaged Relatlimab Serum Concentration Over the First 28 Days (Cavgd28-Rela) on Natural Logarithmic Scale
Prazo: Pre-dose (Day 1 to Day 28)
Blood samples were collected to assess serum concentration.
Pre-dose (Day 1 to Day 28)
Adjusted Trough Nivolumab Serum Concentration at Steady-State (Cminss-Nivo) on Natural Logarithmic Scale
Prazo: Pre-dose (Day 1 to Day 28)
Blood samples were collected to assess serum concentration.
Pre-dose (Day 1 to Day 28)
Adjusted Trough Relatlimab Serum Concentration at Steady-State (Cminss-Rela) on Natural Logarithmic Scale
Prazo: Pre-dose (Day 1 to Day 28)
Blood samples were collected to assess serum concentration.
Pre-dose (Day 1 to Day 28)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Objective Response Rate (ORR) by BICR
Prazo: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Objective response rate (ORR) is defined as the percentage of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Disease Control Rate (ORR) Per BICR
Prazo: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Disease control rate (DCR) is defined as the percentage of participants who achieve a BOR of confirmed Complete Response (CR), confirmed Partial Response (PR), or stable disease (SD), based on BICR assessments (using RECIST 1.1) divided by the number of all randomized participants. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Time to Response (TTR) Per BICR
Prazo: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)

Time to response (TTR) assessed by BICR is defined as the time between the date of randomization and the first confirmed documented response (CR or PR) per RECIST 1.1 criteria.

CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Duration of Response (DoR) Per BICR
Prazo: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Duration of Response (DOR) in months is defined as the time from date of the first documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. CR is complete disappearance of all target lesions except nodal disease; all target nodes must decrease to normal size (short axis < 10 mm). PR is ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. Disease progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Progression Free Survival Per BICR
Prazo: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Progression free survival (PFS) is defined as time from on treatment to disease progression or death (whichever comes first). At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Objective Response Rate (ORR) Per Investigator
Prazo: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Objective response rate (ORR) is defined as the percentage of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on Investigator assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Disease Control Rate (ORR) Per Investigator
Prazo: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Disease control rate (DCR) is defined as the percentage of participants who achieve a BOR of confirmed Complete Response (CR), confirmed Partial Response (PR), or stable disease (SD), based on Investigator assessments (using RECIST 1.1) divided by the number of all randomized participants. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Time to Response (TTR) Per Investigator
Prazo: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)

Time to response (TTR) assessed by Investigator is defined as the time between the date of randomization and the first confirmed documented response (CR or PR) per RECIST 1.1 criteria.

CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Duration of Response (DoR) Per Investigator
Prazo: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Duration of Response (DOR) in months is defined as the time from date of the first documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. CR is complete disappearance of all target lesions except nodal disease; all target nodes must decrease to normal size (short axis < 10 mm). PR is ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. Disease progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Progression Free Survival Per Investigator
Prazo: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Progression free survival (PFS) is defined as time from on treatment to disease progression or death (whichever comes first). At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Overall Survival (OS)
Prazo: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Overall survival is defined as the time from the first dosing date (or from randomization/on treatment) to the date of death from any cause. Median computed using Kaplan-Meier method.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Trough Serum Concentration of Nivolumab and Relatlimab (Cmind28) at Day 28
Prazo: Pre-dose at Day 28
Blood samples were collected to assess serum concentration.
Pre-dose at Day 28
Peak Serum Concentration (Cmax1) After the First Dose of Nivolumab and Relatlimab
Prazo: Post-dose Day 1
Blood samples were collected to assess serum concentration.
Post-dose Day 1
Maximum Observed Concentration at Steady State (Cmaxss) Nivolumab and Relatlimab
Prazo: Post-dose Day 1
Blood samples were collected to assess serum concentration.
Post-dose Day 1
Average Observed Concentration at Steady State (Cavgss) of Nivolumab and Relatlimab
Prazo: Post-dose Day 1
Blood samples were collected to assess serum concentration.
Post-dose Day 1
Number of Participants With Adverse Events, SAEs, AEs Leading to Discontinuation and Deaths
Prazo: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 26 months)
AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence at any dose that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions, results in a congenital abnormality or birth defect, or is an important medical event that may not result in death, be life-threatening, or require hospitalization, but may require medical or surgical intervention to prevent any of the outcomes listed above.
First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 26 months)
Number of Participants With Immune-mediate Adverse Events (IMAEs)
Prazo: First dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months)
AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.
First dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months)
Number of Participants With Other Event of Special Interest (OESI)
Prazo: First dose (Day 1) and 100 days after last dose of study therapy (up to approximately 28 months)
AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.
First dose (Day 1) and 100 days after last dose of study therapy (up to approximately 28 months)
Number of Participants With On-Treatment Worst CTCAE Grade 3-4 Laboratory Parameters
Prazo: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 26 months)
AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.
First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 26 months)
Change From Baseline Functional Assessment of Cancer Therapy -Melanoma (FACT-M) Total Score
Prazo: Baseline (Day 1) and Week 85
The FACT-M questionnaire was used to assess the effects of disease symptoms on functioning and well-being. As a generic cancer-related core, the FACT-M includes the 27-item FACT General (FACT-G) to assess physical well-being (PWB; 7 items), social/family well-being (SWB; 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). In addition, the FACT-M includes a 16-item disease-specific Melanoma Subscale (MS). Each FACT-M item is rated on a 5-point scale ranging from 0 (not at all) to 4 (very much). Scores for the PWB, FWB, SWB, and EWB subscales can be combined to produce a FACT-G total score, which provides an overall indicant of generic quality of life, while the FACT-G and MS scores can be combined to produce a total score for the FACT-M, which provides a composite measure of general and targeted quality of life. Overall scale ranges from 0 to 172, higher values indicate better functioning as well as lower symptom burden.
Baseline (Day 1) and Week 85

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Bristol-Myers Squibb

Colaboradores

Halozyme Therapeutics

Investigadores

  • Diretor de estudo: Bristol-Myers Squibb, Bristol-Myers Squibb

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

6 de março de 2023

Conclusão Primária (Real)

4 de agosto de 2025

Conclusão do estudo (Estimado)

18 de novembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

15 de novembro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de novembro de 2022

Primeira postagem (Real)

22 de novembro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CA224-127
  • U1111-1274-0193 (Outro identificador: WHO)
  • 2022-500967-11-00 (Outro identificador: EU CTR)

Plano para dados de participantes individuais (IPD)

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SIM

Descrição do plano IPD

A BMS fornecerá acesso aos dados anônimos individuais dos participantes mediante solicitação de pesquisadores qualificados e sujeitos a determinados critérios. Informações adicionais sobre a política e o processo de compartilhamento de dados da Bristol Myers Squibb podem ser encontradas em: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Prazo de Compartilhamento de IPD

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Critérios de acesso de compartilhamento IPD

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Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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