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Un estudio de combinación subcutánea de nivolumab + relatlimab en dosis fija (FDC) en melanoma metastásico o irresecable no tratado previamente (RELATIVITY-127)

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

Un estudio de fase 3, aleatorizado, abierto, de combinación de dosis fija de nivolumab + relatlimab subcutáneo versus combinación de dosis fija de nivolumab + relatlimab intravenoso en participantes con melanoma metastásico o irresecable sin tratamiento previo

El propósito de este estudio es demostrar que el nivel de exposición al fármaco del estudio de la formulación subcutánea (SC) de nivolumab + relatlimab FDC no es peor que la administración intravenosa (IV) de nivolumab + relatlimab FDC en participantes con melanoma metastásico o irresecable sin tratamiento previo.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

579

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania, 10117
        • Local Institution - 0060
      • Buxtehude, Alemania, 21614
        • Local Institution - 0038
      • Dortmund, Alemania, 44137
        • Local Institution - 0136
      • Erfurt, Alemania, 99089
        • Local Institution - 0039
      • Essen, Alemania, 45147
        • Local Institution - 0049
      • Frankfurt am Main, Alemania, 60590
        • Local Institution - 0166
      • Giessen, Alemania, 35385
        • Local Institution - 0065
      • Göttingen, Alemania, 37075
        • Local Institution - 0135
      • Hamburg, Alemania, 20251
        • Local Institution - 0138
      • Ludwigshafen, Alemania, 67063
        • Local Institution - 0137
      • Marburg, Alemania, 35043
        • Local Institution - 0165
      • Minden, Alemania, 32429
        • Local Institution - 0044
      • Nuremberg, Alemania, 90419
        • Local Institution - 0112
      • Rostock, Alemania, 18057
        • Local Institution - 0053
      • Tübingen, Alemania, 72076
        • Local Institution - 0081
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Alemania, 69120
        • Local Institution - 0101
      • Ulm, Baden-Wurttemberg, Alemania, 89081
        • Local Institution - 0079
    • Bavaria
      • Regensburg, Bavaria, Alemania, 93042
        • Local Institution - 0011
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Alemania, 23538
        • Local Institution - 0003
  • Australia
    • New South Wales
      • Coffs Harbour, New South Wales, Australia, 2450
        • Local Institution - 0050
      • Orange, New South Wales, Australia, 2800
        • Local Institution - 0175
      • Port Macquarie, New South Wales, Australia, 2444
        • Local Institution - 0172
      • Wagga Wagga, New South Wales, Australia, 2650
        • Local Institution - 0118
      • Waratah, New South Wales, Australia, 2298
        • Local Institution - 0184
      • Westmead, New South Wales, Australia, 2145
        • Local Institution - 0033
      • Wollstonecraft, New South Wales, Australia, 2065
        • Local Institution - 0055
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Local Institution - 0090
    • Victoria
      • Bendigo, Victoria, Australia, 3550
        • Local Institution - 0008
      • Box Hill, Victoria, Australia, 3128
        • Local Institution - 0059
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 0154
      • Melbourne, Victoria, Australia, 3004
        • Local Institution - 0030
      • Traralgon, Victoria, Australia, 3844
        • Local Institution - 0109
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Local Institution - 0106
      • Nedlands, Western Australia, Australia, 6009
        • Local Institution - 0161
  • Austria
      • Graz, Austria, 8036
        • Local Institution - 0027
      • Salzburg, Austria, 5020
        • Local Institution - 0029
      • Sankt Pölten, Austria, 3100
        • Local Institution - 0168
      • Vienna, Austria, 1090
        • Local Institution - 0037
  • 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
  • Chequia
      • Hradec Králové, Chequia, 500 05
        • Local Institution - 0094
      • Olomouc, Chequia, 77900
        • Local Institution - 0091
      • Ostrava Poruba, Chequia, 708 52
        • Local Institution - 0082
      • Prague, Chequia, 182 00
        • Local Institution - 0095
    • NY
      • Prague, NY, Chequia, 128 00
        • Local Institution - 0083
  • 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
  • España
      • Badalona, España, 08916
        • Local Institution - 0134
      • Barcelona, España, 08036
        • Local Institution - 0024
      • Las Palmas de Gran Canaria, España, 35016
        • Local Institution - 0045
      • Madrid, España, 28007
        • Local Institution - 0040
      • Madrid, España, 28050
        • Local Institution - 0056
      • Seville, España, 41009
        • Local Institution - 0006
      • Valencia, España, 46014
        • Local Institution - 0151
      • Valencia, España, 46009
        • Local Institution - 0043
    • A Coruna
      • A Coruña, A Coruna, España, 15006
        • Local Institution - 0086
    • Barcelona
      • Barcelona, Barcelona, España, 08035
        • Local Institution - 0047
    • Gipuzkoa
      • Donostia / San Sebastian, Gipuzkoa, España, 20014
        • Local Institution - 0012
    • Jaen
      • Jaén, Jaen, España, 23007
        • Local Institution - 0153
    • Madrid
      • Madrid, Madrid, España, 28009
        • Local Institution - 0126
      • Madrid, Madrid, España, 28041
        • Local Institution - 0004
    • Valencia
      • Valencia, Valencia, España, 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
  • Finlandia
      • Helsinki, Finlandia, 00029
        • Local Institution - 0164
      • Tampere, Finlandia, 33521
        • Local Institution - 0167
      • Turku, Finlandia, 20520
        • Local Institution - 0162
  • Francia
      • Amiens, Francia, 80054
        • Local Institution - 0007
      • Bayonne, Francia, 64100
        • Local Institution - 0128
      • Bordeaux, Francia, 33000
        • Local Institution - 0022
      • Clermont-Ferrand, Francia, 63003
        • Local Institution - 0129
      • Dijon, Francia, 21079
        • Local Institution - 0046
      • Marseille, Francia, 13385
        • Local Institution - 0117
      • Pierre-Bénite, Francia, 69310
        • Local Institution - 0052
      • Rennes, Francia, 35042
        • Local Institution - 0089
      • Rouen, Francia, 76031
        • Local Institution - 0099
    • Cedex 9
      • Toulouse, Cedex 9, Francia, 31059
        • Local Institution - 0108
    • Indre-Et-Loire
      • Chambray-lès-Tours, Indre-Et-Loire, Francia, 37044
        • Local Institution - 0127
    • Nord
      • Lille, Nord, Francia, 59000
        • Local Institution - 0111
    • OH
      • Nantes, OH, Francia, 44093
        • Local Institution - 0063
    • Val-De-Marne
      • Villejuif, Val-De-Marne, Francia, 94805
        • Local Institution - 0061
    • Île-de-France Region
      • Paris, Île-de-France Region, Francia, 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
  • Italia
      • Bari, Italia, 70124
        • Local Institution - 0051
      • Milan, Italia, 20133
        • Local Institution - 0170
      • Naples, Italia, 80131
        • Local Institution - 0084
      • Perugia, Italia, 06132
        • Local Institution - 0032
      • Roma, Italia, 00168
        • Local Institution - 0064
    • Genova
      • Genova, Genova, Italia, 16132
        • Local Institution - 0077
    • Siena
      • Siena, Siena, Italia, 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
  • Polonia
      • Warsaw, Polonia, 02-781
        • Local Institution - 0066
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polonia, 85-796
        • Local Institution - 0171
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Polonia, 30727
        • Local Institution - 0021
    • Opole Voivodeship
      • Opole, Opole Voivodeship, Polonia, 45-061
        • Local Institution - 0005
    • Wiekopolskie
      • Poznan, Wiekopolskie, Polonia, 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
  • Suecia
      • Lund, Suecia, 222 42
        • Local Institution - 0097
    • Stockholm County
      • Solna, Stockholm County, Suecia, 171 64
        • Local Institution - 0062
  • Suiza
      • Bern, Suiza, 3010
        • Local Institution - 0092
      • Chur, Suiza, 7000
        • Local Institution - 0080
      • Lausanne, Suiza, 1011
        • Local Institution - 0105

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

12 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • Los participantes deben tener un estado funcional del Eastern Cooperative Oncology Group (ECOG) de ≤ 1/Lansky Performance Score ≥ 80 % para adolescentes (≥ 12 a < 18 años de edad).
  • Los participantes deben tener melanoma en estadio III (irresecable) o estadio IV (metastásico) confirmado histológicamente, según el sistema de estadificación del American Joint Committee for Cancer (AJCC).
  • Los participantes deben tener una enfermedad medible mediante tomografía computarizada (TC) o resonancia magnética nuclear (RMN) según los Criterios de evaluación de respuesta en tumores sólidos versión 1.1 (RECIST v1.1).
  • Los participantes deben tener ≥ 12 años de edad. Los participantes que tengan ≥ 12 años y < 18 años (adolescentes) deben pesar ≥ 40 kg al momento de firmar el consentimiento informado (asentimiento).
  • Los participantes deben tener melanoma en estadio III (irresecable) o estadio IV (metastásico) confirmado histológicamente, según el sistema de estadificación del AJCC (octava edición).

Criterio de exclusión:

  • Los participantes no deben tener melanoma ocular.
  • Los participantes no deben tener antecedentes de miocarditis, independientemente de la etiología.
  • Los participantes no deben tener una afección que requiera tratamiento sistémico con corticosteroides (>10 miligramos [mg] equivalentes diarios de prednisona) u otros medicamentos inmunosupresores dentro de los 14 días posteriores al inicio del tratamiento del estudio. Los esteroides inhalados o tópicos y las dosis de esteroides de reemplazo suprarrenal >10 mg diarios equivalentes a prednisona están permitidos en ausencia de enfermedad autoinmune activa.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Nivolumab + Relatlimab FDC SC
Droga: rHuPH20
Dosis especificada en días especificados
Droga: Nivolumab + Relatlimab
Dosis especificada en días especificados
Otros nombres:
  • BMS-986213
  • Opdualag
Comparador activo: Nivolumab + Relatlimab CDF IV
Droga: Nivolumab + Relatlimab
Dosis especificada en días especificados
Otros nombres:
  • BMS-986213
  • Opdualag

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Adjusted Time-Averaged Nivolumab Serum Concentration Over the First 28 Days (Cavgd28-Nivo) on Natural Logarithmic Scale
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Pre-dose (Day 1 to Day 28)
Blood samples were collected to assess serum concentration.
Pre-dose (Day 1 to Day 28)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Objective Response Rate (ORR) by BICR
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Bristol-Myers Squibb

Colaboradores

Halozyme Therapeutics

Investigadores

  • Director de estudio: Bristol-Myers Squibb, Bristol-Myers Squibb

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

6 de marzo de 2023

Finalización primaria (Actual)

4 de agosto de 2025

Finalización del estudio (Estimado)

18 de noviembre de 2027

Fechas de registro del estudio

Enviado por primera vez

15 de noviembre de 2022

Primero enviado que cumplió con los criterios de control de calidad

15 de noviembre de 2022

Publicado por primera vez (Actual)

22 de noviembre de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

BMS proporcionará acceso a datos anónimos de participantes individuales a pedido de investigadores calificados y sujeto a ciertos criterios. Puede encontrar información adicional sobre la política y el proceso de intercambio de datos de Bristol Myers Squibb en: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Marco de tiempo para compartir IPD

Ver descripción del plan

Criterios de acceso compartido de IPD

Ver descripción del plan

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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