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Eine Studie zur subkutanen Nivolumab + Relatlimab-Festdosiskombination (FDC) bei zuvor unbehandeltem metastasiertem oder nicht resezierbarem Melanom (RELATIVITY-127)

3. August 2026 aktualisiert von: Bristol-Myers Squibb

Eine randomisierte, offene Phase-3-Studie mit subkutaner Nivolumab + Relatlimab-Festdosiskombination im Vergleich zu intravenöser Nivolumab + Relatlimab-Festdosiskombination bei Teilnehmern mit zuvor unbehandeltem metastasiertem oder nicht resezierbarem Melanom

Der Zweck dieser Studie besteht darin, zu zeigen, dass die Studienwirkstoffexposition der subkutanen (sc) Formulierung von Nivolumab + Relatlimab FDC nicht schlechter ist als die intravenöse (IV) Verabreichung von Nivolumab + Relatlimab FDC bei Teilnehmern mit zuvor unbehandeltem metastasiertem oder inoperablem Melanom.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

579

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • 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
  • 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
  • Deutschland
      • Berlin, Deutschland, 10117
        • Local Institution - 0060
      • Buxtehude, Deutschland, 21614
        • Local Institution - 0038
      • Dortmund, Deutschland, 44137
        • Local Institution - 0136
      • Erfurt, Deutschland, 99089
        • Local Institution - 0039
      • Essen, Deutschland, 45147
        • Local Institution - 0049
      • Frankfurt am Main, Deutschland, 60590
        • Local Institution - 0166
      • Giessen, Deutschland, 35385
        • Local Institution - 0065
      • Göttingen, Deutschland, 37075
        • Local Institution - 0135
      • Hamburg, Deutschland, 20251
        • Local Institution - 0138
      • Ludwigshafen, Deutschland, 67063
        • Local Institution - 0137
      • Marburg, Deutschland, 35043
        • Local Institution - 0165
      • Minden, Deutschland, 32429
        • Local Institution - 0044
      • Nuremberg, Deutschland, 90419
        • Local Institution - 0112
      • Rostock, Deutschland, 18057
        • Local Institution - 0053
      • Tübingen, Deutschland, 72076
        • Local Institution - 0081
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Deutschland, 69120
        • Local Institution - 0101
      • Ulm, Baden-Wurttemberg, Deutschland, 89081
        • Local Institution - 0079
    • Bavaria
      • Regensburg, Bavaria, Deutschland, 93042
        • Local Institution - 0011
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Deutschland, 23538
        • Local Institution - 0003
  • Finnland
      • Helsinki, Finnland, 00029
        • Local Institution - 0164
      • Tampere, Finnland, 33521
        • Local Institution - 0167
      • Turku, Finnland, 20520
        • Local Institution - 0162
  • Frankreich
      • Amiens, Frankreich, 80054
        • Local Institution - 0007
      • Bayonne, Frankreich, 64100
        • Local Institution - 0128
      • Bordeaux, Frankreich, 33000
        • Local Institution - 0022
      • Clermont-Ferrand, Frankreich, 63003
        • Local Institution - 0129
      • Dijon, Frankreich, 21079
        • Local Institution - 0046
      • Marseille, Frankreich, 13385
        • Local Institution - 0117
      • Pierre-Bénite, Frankreich, 69310
        • Local Institution - 0052
      • Rennes, Frankreich, 35042
        • Local Institution - 0089
      • Rouen, Frankreich, 76031
        • Local Institution - 0099
    • Cedex 9
      • Toulouse, Cedex 9, Frankreich, 31059
        • Local Institution - 0108
    • Indre-Et-Loire
      • Chambray-lès-Tours, Indre-Et-Loire, Frankreich, 37044
        • Local Institution - 0127
    • Nord
      • Lille, Nord, Frankreich, 59000
        • Local Institution - 0111
    • OH
      • Nantes, OH, Frankreich, 44093
        • Local Institution - 0063
    • Val-De-Marne
      • Villejuif, Val-De-Marne, Frankreich, 94805
        • Local Institution - 0061
    • Île-de-France Region
      • Paris, Île-de-France Region, Frankreich, 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
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2N 5G2
        • Local Institution - 0141
    • Ontario
      • Hamilton, Ontario, Kanada, L8V 5C2
        • Local Institution - 0121
      • Ottawa, Ontario, Kanada, K1H 8L6
        • Local Institution - 0096
      • Toronto, Ontario, Kanada, M4N 3M5
        • Local Institution - 0116
    • Quebec
      • Québec, Quebec, Kanada, G1J 1Z4
        • Local Institution - 0103
  • Norwegen
      • Bodø, Norwegen, 8005
        • Local Institution - 0163
      • Grålum, Norwegen, 1714
        • Local Institution - 0156
      • Lørenskog, Norwegen, 1474
        • Local Institution - 0158
      • Oslo, Norwegen, 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
  • Schweden
      • Lund, Schweden, 222 42
        • Local Institution - 0097
    • Stockholm County
      • Solna, Stockholm County, Schweden, 171 64
        • Local Institution - 0062
  • 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
  • Tschechien
      • Hradec Králové, Tschechien, 500 05
        • Local Institution - 0094
      • Olomouc, Tschechien, 77900
        • Local Institution - 0091
      • Ostrava Poruba, Tschechien, 708 52
        • Local Institution - 0082
      • Prague, Tschechien, 182 00
        • Local Institution - 0095
    • NY
      • Prague, NY, Tschechien, 128 00
        • Local Institution - 0083
  • Vereinigte Staaten
    • Arizona
      • Phoenix, Arizona, Vereinigte Staaten, 85013
        • Local Institution - 0125
    • Arkansas
      • Springdale, Arkansas, Vereinigte Staaten, 72762
        • Local Institution - 0189
    • California
      • Los Angeles, California, Vereinigte Staaten, 90025
        • Local Institution - 0098
      • Orange, California, Vereinigte Staaten, 92868-3201
        • Local Institution - 0093
      • Stanford, California, Vereinigte Staaten, 94305
        • Local Institution - 0123
    • Colorado
      • Englewood, Colorado, Vereinigte Staaten, 80113
        • Local Institution - 0113
    • Florida
      • Jacksonville, Florida, Vereinigte Staaten, 32224
        • Local Institution - 0114
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21201
        • Local Institution - 0146
    • Minnesota
      • Rochester, Minnesota, Vereinigte Staaten, 55905
        • Local Institution - 0071
    • Nebraska
      • Omaha, Nebraska, Vereinigte Staaten, 68130
        • Local Institution - 0013
    • Ohio
      • Cleveland, Ohio, Vereinigte Staaten, 44195
        • Local Institution - 0169
    • Pennsylvania
      • Easton, Pennsylvania, Vereinigte Staaten, 18045
        • Local Institution - 0139
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19107
        • Local Institution - 0124
    • Utah
      • Murray, Utah, Vereinigte Staaten, 84107
        • Local Institution - 0122
    • Virginia
      • Fairfax, Virginia, Vereinigte Staaten, 22031
        • Local Institution - 0115
  • Vereinigtes Königreich
    • Greater London
      • London, Greater London, Vereinigtes Königreich, SW3 6JJ
        • Local Institution - 0088
    • Oxfordshire
      • Headington, Oxford, Oxfordshire, Vereinigtes Königreich, OX3 7LE
        • Local Institution - 0068
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, Vereinigtes Königreich, NE7 7DN
        • Local Institution - 0120
  • Österreich
      • Graz, Österreich, 8036
        • Local Institution - 0027
      • Salzburg, Österreich, 5020
        • Local Institution - 0029
      • Sankt Pölten, Österreich, 3100
        • Local Institution - 0168
      • Vienna, Österreich, 1090
        • Local Institution - 0037

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

12 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

  • Die Teilnehmer müssen einen Leistungsstatus der Eastern Cooperative Oncology Group (ECOG) von ≤ 1/Lansky Performance Score ≥ 80 % für Jugendliche (≥ 12 bis < 18 Jahre) haben.
  • Die Teilnehmer müssen gemäß dem Staging-System des American Joint Committee for Cancer (AJCC) ein histologisch bestätigtes Melanom im Stadium III (nicht resezierbar) oder Stadium IV (metastasiert) haben.
  • Die Teilnehmer müssen gemäß den Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) eine durch Computertomographie (CT) oder Magnetresonanztomographie (MRT) messbare Erkrankung aufweisen.
  • Die Teilnehmer müssen ≥ 12 Jahre alt sein. Teilnehmer, die ≥ 12 Jahre und < 18 Jahre alt sind (Jugendliche), müssen zum Zeitpunkt der Unterzeichnung der Einverständniserklärung (Zustimmung) ≥ 40 kg wiegen.
  • Die Teilnehmer müssen ein histologisch bestätigtes Melanom im Stadium III (nicht resezierbar) oder Stadium IV (metastasiert) gemäß dem AJCC-Klassifikationssystem (8. Ausgabe) haben.

Ausschlusskriterien:

  • Die Teilnehmer dürfen kein Augenmelanom haben.
  • Die Teilnehmer dürfen unabhängig von der Ätiologie keine Myokarditis in der Vorgeschichte haben.
  • Die Teilnehmer dürfen innerhalb von 14 Tagen nach Beginn der Studienbehandlung keine Erkrankung haben, die eine systemische Behandlung mit Kortikosteroiden (> 10 Milligramm [mg] täglich Prednisonäquivalent) oder anderen immunsuppressiven Medikamenten erfordert. Inhalative oder topische Steroide und Nebennierenersatz-Steroiddosen > 10 mg Prednisonäquivalent pro Tag sind erlaubt, wenn keine aktive Autoimmunerkrankung vorliegt.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Nivolumab + Relatlimab FDC SC
Arzneimittel: rHuPH20
Angegebene Dosis an bestimmten Tagen
Arzneimittel: Nivolumab + Relatlimab
Angegebene Dosis an bestimmten Tagen
Andere Namen:
  • BMS-986213
  • Opdualag
Aktiver Komparator: Nivolumab + Relatlimab FDC IV
Arzneimittel: Nivolumab + Relatlimab
Angegebene Dosis an bestimmten Tagen
Andere Namen:
  • BMS-986213
  • Opdualag

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Objective Response Rate (ORR) by BICR
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Bristol-Myers Squibb

Mitarbeiter

Halozyme Therapeutics

Ermittler

  • Studienleiter: Bristol-Myers Squibb, Bristol-Myers Squibb

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

6. März 2023

Primärer Abschluss (Tatsächlich)

4. August 2025

Studienabschluss (Geschätzt)

18. November 2027

Studienanmeldedaten

Zuerst eingereicht

15. November 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. November 2022

Zuerst gepostet (Tatsächlich)

22. November 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

BMS gewährt auf Anfrage von qualifizierten Forschern und vorbehaltlich bestimmter Kriterien Zugang zu individuellen anonymisierten Teilnehmerdaten. Weitere Informationen zu den Richtlinien und Verfahren zum Datenaustausch von Bristol Myers Squibb finden Sie unter: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

IPD-Sharing-Zeitrahmen

Siehe Planbeschreibung

IPD-Sharing-Zugriffskriterien

Siehe Planbeschreibung

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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