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En undersøgelse af subkutan Nivolumab + Relatlimab Fixed-Dosis Combination (FDC) i tidligere ubehandlet metastatisk eller ikke-operabelt melanom (RELATIVITY-127)

3. august 2026 opdateret af: Bristol-Myers Squibb

En fase 3, randomiseret, åben-label, undersøgelse af subkutan Nivolumab + Relatlimab fastdosiskombination versus intravenøs Nivolumab + Relatlimab fastdosiskombination hos deltagere med tidligere ubehandlet metastatisk eller ikke-operabelt melanom

Formålet med denne undersøgelse er at demonstrere, at eksponeringsniveauet for undersøgelseslægemidlet i nivolumab + relatlimab FDC subkutan (SC) formulering ikke er værre end nivolumab + relatlimab FDC intravenøs (IV) administration hos deltagere med tidligere ubehandlet metastatisk eller ikke-operabelt melanom.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

579

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Deltagerne skal have en præstationsstatus for Eastern Cooperative Oncology Group (ECOG) på ≤ 1/Lansky Performance Score ≥ 80 % for unge (≥ 12 til < 18 år).
  • Deltagerne skal have histologisk bekræftet trin III (ikke-opererbar) eller trin IV (metastatisk) melanom ifølge American Joint Committee for Cancer (AJCC) stadiesystem.
  • Deltagerne skal have målbar sygdom ved computertomografi (CT) eller magnetisk resonansbilleddannelse (MRI) i henhold til responsevalueringskriterier i solide tumorer version 1.1 (RECIST v1.1).
  • Deltagerne skal være ≥ 12 år. Deltagere, der er ≥ 12 år og < 18 år (unge) skal veje ≥ 40 kg på tidspunktet for underskrivelse af det informerede samtykke (samtykke).
  • Deltagerne skal have histologisk bekræftet trin III (ikke-opererbar) eller trin IV (metastatisk) melanom ifølge AJCC-stadiesystemet (8. udgave).

Ekskluderingskriterier:

  • Deltagerne må ikke have okulært melanom.
  • Deltagerne må ikke have en historie med myokarditis, uanset ætiologi.
  • Deltagerne må ikke have en tilstand, der kræver systemisk behandling med enten kortikosteroider (>10 milligram [mg] dagligt prednisonækvivalent) eller anden immunsuppressiv medicin inden for 14 dage efter start af studiebehandlingen. Inhalerede eller topiske steroider og binyresubstitutionssteroiddoser >10 mg dagligt prednisonækvivalent er tilladt i fravær af aktiv autoimmun sygdom.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Nivolumab + Relatlimab FDC SC
Medicin: rHuPH20
Specificeret dosis på specificerede dage
Medicin: Nivolumab + Relatlimab
Specificeret dosis på specificerede dage
Andre navne:
  • BMS-986213
  • Opdualag
Aktiv komparator: Nivolumab + Relatlimab FDC IV
Medicin: Nivolumab + Relatlimab
Specificeret dosis på specificerede dage
Andre navne:
  • BMS-986213
  • Opdualag

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adjusted Time-Averaged Nivolumab Serum Concentration Over the First 28 Days (Cavgd28-Nivo) on Natural Logarithmic Scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Pre-dose (Day 1 to Day 28)
Blood samples were collected to assess serum concentration.
Pre-dose (Day 1 to Day 28)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate (ORR) by BICR
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bristol-Myers Squibb

Samarbejdspartnere

Halozyme Therapeutics

Efterforskere

  • Studieleder: Bristol-Myers Squibb, Bristol-Myers Squibb

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. marts 2023

Primær færdiggørelse (Faktiske)

4. august 2025

Studieafslutning (Anslået)

18. november 2027

Datoer for studieregistrering

Først indsendt

15. november 2022

Først indsendt, der opfyldte QC-kriterier

15. november 2022

Først opslået (Faktiske)

22. november 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

BMS vil give adgang til individuelle anonymiserede deltagerdata efter anmodning fra kvalificerede forskere og underlagt visse kriterier. Yderligere oplysninger om Bristol Myers Squibbs datadelingspolitik og -proces kan findes på: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

IPD-delingstidsramme

Se Planbeskrivelse

IPD-delingsadgangskriterier

Se Planbeskrivelse

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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