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Uno studio sulla combinazione sottocutanea di Nivolumab + Relatlimab a dose fissa (FDC) nel melanoma metastatico o non resecabile precedentemente non trattato (RELATIVITY-127)

3 agosto 2026 aggiornato da: Bristol-Myers Squibb

Uno studio di fase 3, randomizzato, in aperto, sulla combinazione a dose fissa di Nivolumab + Relatlimab per via sottocutanea rispetto alla combinazione a dose fissa di Nivolumab + Relatlimab per via endovenosa in partecipanti con melanoma metastatico o non resecabile precedentemente non trattato

Lo scopo di questo studio è dimostrare che il livello di esposizione al farmaco in studio della formulazione sottocutanea (SC) di nivolumab + relatlimab FDC non è peggiore della somministrazione endovenosa (IV) di nivolumab + relatlimab FDC nei partecipanti con melanoma metastatico o non resecabile precedentemente non trattato.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

579

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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
  • Belgio
      • Brussels, Belgio, 1200
        • Local Institution - 0072
      • Charleroi, Belgio, 6000
        • Local Institution - 0078
      • Liège, Belgio, 4000
        • Local Institution - 0016
  • Brasile
    • Ceará
      • Fortaleza, Ceará, Brasile, 60135237
        • Local Institution - 0177
    • Espírito Santo
      • Vitória, Espírito Santo, Brasile, 29043-260
        • Local Institution - 0180
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasile, 30130-090
        • Local Institution - 0107
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brasile, 98700-000
        • Local Institution - 0025
      • Porto Alegre, Rio Grande do Sul, Brasile, 90035-903
        • Local Institution - 0031
      • Porto Alegre, Rio Grande do Sul, Brasile, 90610-000
        • Local Institution - 0058
      • Porto Alegrelegre, Rio Grande do Sul, Brasile, 91350-250
        • Local Institution - 0002
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brasile, 20220-410
        • Local Institution - 0110
    • Santa Catarina
      • Blumenau, Santa Catarina, Brasile, 89010-340
        • Local Institution - 0159
    • São Paulo
      • Barretos, São Paulo, Brasile, 14784-400
        • Local Institution - 0009
      • São José do Rio Preto, São Paulo, Brasile, 15090-000
        • Local Institution - 0018
      • São Paulo, São Paulo, Brasile, 01321-001
        • Local Institution - 0130
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Local Institution - 0141
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Local Institution - 0121
      • Ottawa, Ontario, Canada, K1H 8L6
        • Local Institution - 0096
      • Toronto, Ontario, Canada, M4N 3M5
        • Local Institution - 0116
    • Quebec
      • Québec, Quebec, Canada, G1J 1Z4
        • Local Institution - 0103
  • Cechia
      • Hradec Králové, Cechia, 500 05
        • Local Institution - 0094
      • Olomouc, Cechia, 77900
        • Local Institution - 0091
      • Ostrava Poruba, Cechia, 708 52
        • Local Institution - 0082
      • Prague, Cechia, 182 00
        • Local Institution - 0095
    • NY
      • Prague, NY, Cechia, 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
  • 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
  • Germania
      • Berlin, Germania, 10117
        • Local Institution - 0060
      • Buxtehude, Germania, 21614
        • Local Institution - 0038
      • Dortmund, Germania, 44137
        • Local Institution - 0136
      • Erfurt, Germania, 99089
        • Local Institution - 0039
      • Essen, Germania, 45147
        • Local Institution - 0049
      • Frankfurt am Main, Germania, 60590
        • Local Institution - 0166
      • Giessen, Germania, 35385
        • Local Institution - 0065
      • Göttingen, Germania, 37075
        • Local Institution - 0135
      • Hamburg, Germania, 20251
        • Local Institution - 0138
      • Ludwigshafen, Germania, 67063
        • Local Institution - 0137
      • Marburg, Germania, 35043
        • Local Institution - 0165
      • Minden, Germania, 32429
        • Local Institution - 0044
      • Nuremberg, Germania, 90419
        • Local Institution - 0112
      • Rostock, Germania, 18057
        • Local Institution - 0053
      • Tübingen, Germania, 72076
        • Local Institution - 0081
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germania, 69120
        • Local Institution - 0101
      • Ulm, Baden-Wurttemberg, Germania, 89081
        • Local Institution - 0079
    • Bavaria
      • Regensburg, Bavaria, Germania, 93042
        • Local Institution - 0011
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germania, 23538
        • Local Institution - 0003
  • Israele
      • Afula, Israele, 1834111
        • Local Institution - 0026
      • Petah-Tikvah, Israele, 4941492
        • Local Institution - 0102
      • Tel Aviv, Israele, 6423906
        • Local Institution - 0173
      • Tel Litwinsky, Israele, 5262100
        • Local Institution - 0035
    • Israel
      • Jerusalem, Israel, Israele, 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
  • Norvegia
      • Bodø, Norvegia, 8005
        • Local Institution - 0163
      • Grålum, Norvegia, 1714
        • Local Institution - 0156
      • Lørenskog, Norvegia, 1474
        • Local Institution - 0158
      • Oslo, Norvegia, 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
  • Regno Unito
    • Greater London
      • London, Greater London, Regno Unito, SW3 6JJ
        • Local Institution - 0088
    • Oxfordshire
      • Headington, Oxford, Oxfordshire, Regno Unito, OX3 7LE
        • Local Institution - 0068
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, Regno Unito, NE7 7DN
        • Local Institution - 0120
  • Spagna
      • Badalona, Spagna, 08916
        • Local Institution - 0134
      • Barcelona, Spagna, 08036
        • Local Institution - 0024
      • Las Palmas de Gran Canaria, Spagna, 35016
        • Local Institution - 0045
      • Madrid, Spagna, 28007
        • Local Institution - 0040
      • Madrid, Spagna, 28050
        • Local Institution - 0056
      • Seville, Spagna, 41009
        • Local Institution - 0006
      • Valencia, Spagna, 46014
        • Local Institution - 0151
      • Valencia, Spagna, 46009
        • Local Institution - 0043
    • A Coruna
      • A Coruña, A Coruna, Spagna, 15006
        • Local Institution - 0086
    • Barcelona
      • Barcelona, Barcelona, Spagna, 08035
        • Local Institution - 0047
    • Gipuzkoa
      • Donostia / San Sebastian, Gipuzkoa, Spagna, 20014
        • Local Institution - 0012
    • Jaen
      • Jaén, Jaen, Spagna, 23007
        • Local Institution - 0153
    • Madrid
      • Madrid, Madrid, Spagna, 28009
        • Local Institution - 0126
      • Madrid, Madrid, Spagna, 28041
        • Local Institution - 0004
    • Valencia
      • Valencia, Valencia, Spagna, 46009
        • Local Institution - 0041
  • Stati Uniti
    • Arizona
      • Phoenix, Arizona, Stati Uniti, 85013
        • Local Institution - 0125
    • Arkansas
      • Springdale, Arkansas, Stati Uniti, 72762
        • Local Institution - 0189
    • California
      • Los Angeles, California, Stati Uniti, 90025
        • Local Institution - 0098
      • Orange, California, Stati Uniti, 92868-3201
        • Local Institution - 0093
      • Stanford, California, Stati Uniti, 94305
        • Local Institution - 0123
    • Colorado
      • Englewood, Colorado, Stati Uniti, 80113
        • Local Institution - 0113
    • Florida
      • Jacksonville, Florida, Stati Uniti, 32224
        • Local Institution - 0114
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21201
        • Local Institution - 0146
    • Minnesota
      • Rochester, Minnesota, Stati Uniti, 55905
        • Local Institution - 0071
    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68130
        • Local Institution - 0013
    • Ohio
      • Cleveland, Ohio, Stati Uniti, 44195
        • Local Institution - 0169
    • Pennsylvania
      • Easton, Pennsylvania, Stati Uniti, 18045
        • Local Institution - 0139
      • Philadelphia, Pennsylvania, Stati Uniti, 19107
        • Local Institution - 0124
    • Utah
      • Murray, Utah, Stati Uniti, 84107
        • Local Institution - 0122
    • Virginia
      • Fairfax, Virginia, Stati Uniti, 22031
        • Local Institution - 0115
  • Svezia
      • Lund, Svezia, 222 42
        • Local Institution - 0097
    • Stockholm County
      • Solna, Stockholm County, Svezia, 171 64
        • Local Institution - 0062
  • Svizzera
      • Bern, Svizzera, 3010
        • Local Institution - 0092
      • Chur, Svizzera, 7000
        • Local Institution - 0080
      • Lausanne, Svizzera, 1011
        • Local Institution - 0105

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

12 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • I partecipanti devono avere un performance status ECOG (Eastern Cooperative Oncology Group) ≤ 1/Punteggio Lansky Performance ≥ 80% per gli adolescenti (da ≥ 12 a < 18 anni di età).
  • I partecipanti devono avere un melanoma di stadio III (non resecabile) o stadio IV (metastatico) confermato istologicamente, secondo il sistema di stadiazione dell'American Joint Committee for Cancer (AJCC).
  • I partecipanti devono avere una malattia misurabile mediante tomografia computerizzata (TC) o risonanza magnetica (MRI) in base ai criteri di valutazione della risposta nei tumori solidi versione 1.1 (RECIST v1.1).
  • I partecipanti devono avere un'età ≥ 12 anni. I partecipanti di età ≥ 12 anni e < 18 anni (adolescenti) devono pesare ≥ 40 kg al momento della firma del consenso informato (assenso).
  • I partecipanti devono avere un melanoma di stadio III (non resecabile) o stadio IV (metastatico) confermato istologicamente, secondo il sistema di stadiazione AJCC (8a edizione).

Criteri di esclusione:

  • I partecipanti non devono avere melanoma oculare.
  • I partecipanti non devono avere una storia di miocardite, indipendentemente dall'eziologia.
  • I partecipanti non devono avere una condizione che richieda un trattamento sistemico con corticosteroidi (> 10 milligrammi [mg] di prednisone al giorno equivalente) o altri farmaci immunosoppressori entro 14 giorni dall'inizio del trattamento in studio. In assenza di malattia autoimmune attiva, sono consentiti steroidi per via inalatoria o topici e dosi di steroidi surrenalici sostitutivi >10 mg giornalieri equivalenti di prednisone.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Nivolumab + Relatlimab FDC SC
Droga: rHuPH20
Dose specificata nei giorni specificati
Droga: Nivolumab + Relatlimab
Dose specificata nei giorni specificati
Altri nomi:
  • BMS-986213
  • Opdualag
Comparatore attivo: Nivolumab + Relatlimab FDC IV
Droga: Nivolumab + Relatlimab
Dose specificata nei giorni specificati
Altri nomi:
  • BMS-986213
  • Opdualag

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adjusted Time-Averaged Nivolumab Serum Concentration Over the First 28 Days (Cavgd28-Nivo) on Natural Logarithmic Scale
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Pre-dose (Day 1 to Day 28)
Blood samples were collected to assess serum concentration.
Pre-dose (Day 1 to Day 28)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Objective Response Rate (ORR) by BICR
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bristol-Myers Squibb

Collaboratori

Halozyme Therapeutics

Investigatori

  • Direttore dello studio: Bristol-Myers Squibb, Bristol-Myers Squibb

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

6 marzo 2023

Completamento primario (Effettivo)

4 agosto 2025

Completamento dello studio (Stimato)

18 novembre 2027

Date di iscrizione allo studio

Primo inviato

15 novembre 2022

Primo inviato che soddisfa i criteri di controllo qualità

15 novembre 2022

Primo Inserito (Effettivo)

22 novembre 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

BMS fornirà l'accesso ai dati dei singoli partecipanti resi anonimi su richiesta di ricercatori qualificati e soggetti a determinati criteri. Ulteriori informazioni sulla politica e sul processo di condivisione dei dati di Bristol Myers Squibb sono disponibili all'indirizzo: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Periodo di condivisione IPD

Vedere la descrizione del piano

Criteri di accesso alla condivisione IPD

Vedere la descrizione del piano

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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