Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

Tutkimus ihonalaisesta nivolumabin ja relatlimabin kiinteän annoksen yhdistelmästä (FDC) aiemmin hoitamattomassa metastaattisessa tai leikkauttamattomassa melanoomassa (RELATIVITY-127)

maanantai 3. elokuuta 2026 päivittänyt: Bristol-Myers Squibb

Vaihe 3, satunnaistettu, avoin tutkimus ihonalaisen nivolumabin + relatlimabi kiinteän annoksen yhdistelmästä vs. suonensisäinen nivolumabi + relatlimabi kiinteän annoksen yhdistelmä osallistujilla, joilla on aiemmin hoitamaton metastaattinen tai leikkauskelvoton melanooma

Tämän tutkimuksen tarkoituksena on osoittaa, että nivolumabi + relatlimabi FDC ihonalaisen (SC) formulaation tutkimuslääkealtistustaso ei ole huonompi kuin nivolumabi + relatlimabi FDC suonensisäinen (IV) annostelu osallistujille, joilla on aiemmin hoitamaton metastaattinen tai leikkauskelvoton melanooma.

Tutkimuksen yleiskatsaus

Tila

Aktiivinen, ei rekrytointi

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

579

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • 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
  • Belgia
      • Brussels, Belgia, 1200
        • Local Institution - 0072
      • Charleroi, Belgia, 6000
        • Local Institution - 0078
      • Liège, Belgia, 4000
        • Local Institution - 0016
  • Brasilia
    • Ceará
      • Fortaleza, Ceará, Brasilia, 60135237
        • Local Institution - 0177
    • Espírito Santo
      • Vitória, Espírito Santo, Brasilia, 29043-260
        • Local Institution - 0180
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasilia, 30130-090
        • Local Institution - 0107
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brasilia, 98700-000
        • Local Institution - 0025
      • Porto Alegre, Rio Grande do Sul, Brasilia, 90035-903
        • Local Institution - 0031
      • Porto Alegre, Rio Grande do Sul, Brasilia, 90610-000
        • Local Institution - 0058
      • Porto Alegrelegre, Rio Grande do Sul, Brasilia, 91350-250
        • Local Institution - 0002
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brasilia, 20220-410
        • Local Institution - 0110
    • Santa Catarina
      • Blumenau, Santa Catarina, Brasilia, 89010-340
        • Local Institution - 0159
    • São Paulo
      • Barretos, São Paulo, Brasilia, 14784-400
        • Local Institution - 0009
      • São José do Rio Preto, São Paulo, Brasilia, 15090-000
        • Local Institution - 0018
      • São Paulo, São Paulo, Brasilia, 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
  • Espanja
      • Badalona, Espanja, 08916
        • Local Institution - 0134
      • Barcelona, Espanja, 08036
        • Local Institution - 0024
      • Las Palmas de Gran Canaria, Espanja, 35016
        • Local Institution - 0045
      • Madrid, Espanja, 28007
        • Local Institution - 0040
      • Madrid, Espanja, 28050
        • Local Institution - 0056
      • Seville, Espanja, 41009
        • Local Institution - 0006
      • Valencia, Espanja, 46014
        • Local Institution - 0151
      • Valencia, Espanja, 46009
        • Local Institution - 0043
    • A Coruna
      • A Coruña, A Coruna, Espanja, 15006
        • Local Institution - 0086
    • Barcelona
      • Barcelona, Barcelona, Espanja, 08035
        • Local Institution - 0047
    • Gipuzkoa
      • Donostia / San Sebastian, Gipuzkoa, Espanja, 20014
        • Local Institution - 0012
    • Jaen
      • Jaén, Jaen, Espanja, 23007
        • Local Institution - 0153
    • Madrid
      • Madrid, Madrid, Espanja, 28009
        • Local Institution - 0126
      • Madrid, Madrid, Espanja, 28041
        • Local Institution - 0004
    • Valencia
      • Valencia, Valencia, Espanja, 46009
        • Local Institution - 0041
  • Israel
      • Afula, Israel, 1834111
        • Local Institution - 0026
      • Petah-Tikvah, Israel, 4941492
        • Local Institution - 0102
      • Tel Aviv, Israel, 6423906
        • Local Institution - 0173
      • Tel Litwinsky, Israel, 5262100
        • Local Institution - 0035
    • Israel
      • Jerusalem, Israel, Israel, 9112001
        • Local Institution - 0054
  • Italia
      • Bari, Italia, 70124
        • Local Institution - 0051
      • Milan, Italia, 20133
        • Local Institution - 0170
      • Naples, Italia, 80131
        • Local Institution - 0084
      • Perugia, Italia, 06132
        • Local Institution - 0032
      • Roma, Italia, 00168
        • Local Institution - 0064
    • Genova
      • Genova, Genova, Italia, 16132
        • Local Institution - 0077
    • Siena
      • Siena, Siena, Italia, 53100
        • Local Institution - 0014
  • Itävalta
      • Graz, Itävalta, 8036
        • Local Institution - 0027
      • Salzburg, Itävalta, 5020
        • Local Institution - 0029
      • Sankt Pölten, Itävalta, 3100
        • Local Institution - 0168
      • Vienna, Itävalta, 1090
        • Local Institution - 0037
  • 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
  • Norja
      • Bodø, Norja, 8005
        • Local Institution - 0163
      • Grålum, Norja, 1714
        • Local Institution - 0156
      • Lørenskog, Norja, 1474
        • Local Institution - 0158
      • Oslo, Norja, 0379
        • Local Institution - 0155
  • Puola
      • Warsaw, Puola, 02-781
        • Local Institution - 0066
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Puola, 85-796
        • Local Institution - 0171
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Puola, 30727
        • Local Institution - 0021
    • Opole Voivodeship
      • Opole, Opole Voivodeship, Puola, 45-061
        • Local Institution - 0005
    • Wiekopolskie
      • Poznan, Wiekopolskie, Puola, 60-780
        • Local Institution - 0015
  • Ranska
      • Amiens, Ranska, 80054
        • Local Institution - 0007
      • Bayonne, Ranska, 64100
        • Local Institution - 0128
      • Bordeaux, Ranska, 33000
        • Local Institution - 0022
      • Clermont-Ferrand, Ranska, 63003
        • Local Institution - 0129
      • Dijon, Ranska, 21079
        • Local Institution - 0046
      • Marseille, Ranska, 13385
        • Local Institution - 0117
      • Pierre-Bénite, Ranska, 69310
        • Local Institution - 0052
      • Rennes, Ranska, 35042
        • Local Institution - 0089
      • Rouen, Ranska, 76031
        • Local Institution - 0099
    • Cedex 9
      • Toulouse, Cedex 9, Ranska, 31059
        • Local Institution - 0108
    • Indre-Et-Loire
      • Chambray-lès-Tours, Indre-Et-Loire, Ranska, 37044
        • Local Institution - 0127
    • Nord
      • Lille, Nord, Ranska, 59000
        • Local Institution - 0111
    • OH
      • Nantes, OH, Ranska, 44093
        • Local Institution - 0063
    • Val-De-Marne
      • Villejuif, Val-De-Marne, Ranska, 94805
        • Local Institution - 0061
    • Île-de-France Region
      • Paris, Île-de-France Region, Ranska, 75475
        • Local Institution - 0034
  • Ruotsi
      • Lund, Ruotsi, 222 42
        • Local Institution - 0097
    • Stockholm County
      • Solna, Stockholm County, Ruotsi, 171 64
        • Local Institution - 0062
  • Saksa
      • Berlin, Saksa, 10117
        • Local Institution - 0060
      • Buxtehude, Saksa, 21614
        • Local Institution - 0038
      • Dortmund, Saksa, 44137
        • Local Institution - 0136
      • Erfurt, Saksa, 99089
        • Local Institution - 0039
      • Essen, Saksa, 45147
        • Local Institution - 0049
      • Frankfurt am Main, Saksa, 60590
        • Local Institution - 0166
      • Giessen, Saksa, 35385
        • Local Institution - 0065
      • Göttingen, Saksa, 37075
        • Local Institution - 0135
      • Hamburg, Saksa, 20251
        • Local Institution - 0138
      • Ludwigshafen, Saksa, 67063
        • Local Institution - 0137
      • Marburg, Saksa, 35043
        • Local Institution - 0165
      • Minden, Saksa, 32429
        • Local Institution - 0044
      • Nuremberg, Saksa, 90419
        • Local Institution - 0112
      • Rostock, Saksa, 18057
        • Local Institution - 0053
      • Tübingen, Saksa, 72076
        • Local Institution - 0081
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Saksa, 69120
        • Local Institution - 0101
      • Ulm, Baden-Wurttemberg, Saksa, 89081
        • Local Institution - 0079
    • Bavaria
      • Regensburg, Bavaria, Saksa, 93042
        • Local Institution - 0011
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Saksa, 23538
        • Local Institution - 0003
  • Suomi
      • Helsinki, Suomi, 00029
        • Local Institution - 0164
      • Tampere, Suomi, 33521
        • Local Institution - 0167
      • Turku, Suomi, 20520
        • Local Institution - 0162
  • Sveitsi
      • Bern, Sveitsi, 3010
        • Local Institution - 0092
      • Chur, Sveitsi, 7000
        • Local Institution - 0080
      • Lausanne, Sveitsi, 1011
        • Local Institution - 0105
  • Tšekki
      • Hradec Králové, Tšekki, 500 05
        • Local Institution - 0094
      • Olomouc, Tšekki, 77900
        • Local Institution - 0091
      • Ostrava Poruba, Tšekki, 708 52
        • Local Institution - 0082
      • Prague, Tšekki, 182 00
        • Local Institution - 0095
    • NY
      • Prague, NY, Tšekki, 128 00
        • Local Institution - 0083
  • Yhdistynyt kuningaskunta
    • Greater London
      • London, Greater London, Yhdistynyt kuningaskunta, SW3 6JJ
        • Local Institution - 0088
    • Oxfordshire
      • Headington, Oxford, Oxfordshire, Yhdistynyt kuningaskunta, OX3 7LE
        • Local Institution - 0068
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, Yhdistynyt kuningaskunta, NE7 7DN
        • Local Institution - 0120
  • Yhdysvallat
    • Arizona
      • Phoenix, Arizona, Yhdysvallat, 85013
        • Local Institution - 0125
    • Arkansas
      • Springdale, Arkansas, Yhdysvallat, 72762
        • Local Institution - 0189
    • California
      • Los Angeles, California, Yhdysvallat, 90025
        • Local Institution - 0098
      • Orange, California, Yhdysvallat, 92868-3201
        • Local Institution - 0093
      • Stanford, California, Yhdysvallat, 94305
        • Local Institution - 0123
    • Colorado
      • Englewood, Colorado, Yhdysvallat, 80113
        • Local Institution - 0113
    • Florida
      • Jacksonville, Florida, Yhdysvallat, 32224
        • Local Institution - 0114
    • Maryland
      • Baltimore, Maryland, Yhdysvallat, 21201
        • Local Institution - 0146
    • Minnesota
      • Rochester, Minnesota, Yhdysvallat, 55905
        • Local Institution - 0071
    • Nebraska
      • Omaha, Nebraska, Yhdysvallat, 68130
        • Local Institution - 0013
    • Ohio
      • Cleveland, Ohio, Yhdysvallat, 44195
        • Local Institution - 0169
    • Pennsylvania
      • Easton, Pennsylvania, Yhdysvallat, 18045
        • Local Institution - 0139
      • Philadelphia, Pennsylvania, Yhdysvallat, 19107
        • Local Institution - 0124
    • Utah
      • Murray, Utah, Yhdysvallat, 84107
        • Local Institution - 0122
    • Virginia
      • Fairfax, Virginia, Yhdysvallat, 22031
        • Local Institution - 0115

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

12 vuotta ja vanhemmat (Lapsi, Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

Sisällyttämiskriteerit:

  • Osallistujilla tulee olla Eastern Cooperative Oncology Groupin (ECOG) suorituskykytaso ≤ 1/Lansky Performance Score ≥ 80 % nuorille (≥ 12 - < 18-vuotiaat).
  • Osallistujilla on oltava histologisesti vahvistettu vaiheen III (leikkauskelvoton) tai vaiheen IV (metastaattinen) melanooma American Joint Committee for Cancer (AJCC) -määritysjärjestelmän mukaisesti.
  • Osallistujilla on oltava mitattavissa oleva sairaus tietokonetomografialla (CT) tai magneettikuvauksella (MRI) vasteen arviointiperusteiden mukaisesti kiinteiden kasvaimien versiossa 1.1 (RECIST v1.1).
  • Osallistujien tulee olla ≥ 12-vuotiaita. Osallistujien, jotka ovat ≥ 12-vuotiaita ja < 18-vuotiaita (nuoret), tulee painaa ≥ 40 kg tietoisen suostumuksen allekirjoitushetkellä.
  • Osallistujilla on oltava histologisesti vahvistettu vaiheen III (leikkauskelvoton) tai vaiheen IV (metastaattinen) melanooma AJCC-vaiheen määritysjärjestelmän mukaisesti (8. painos).

Poissulkemiskriteerit:

  • Osallistujilla ei saa olla silmämelanoomaa.
  • Osallistujilla ei saa olla sydänlihastulehdusta etiologiasta riippumatta.
  • Osallistujilla ei saa olla sairautta, joka vaatii systeemistä hoitoa kortikosteroideilla (> 10 milligrammaa [mg] päivittäistä prednisonia ekvivalenttia) tai muilla immunosuppressiivisilla lääkkeillä 14 päivän kuluessa tutkimushoidon aloittamisesta. Inhaloitavat tai paikalliset steroidit ja lisämunuaisen korvaussteroidiannokset > 10 mg prednisonia ekvivalenttia päivässä ovat sallittuja, jos aktiivista autoimmuunisairautta ei ole.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Nivolumabi + Relatlimab FDC SC
Lääke: rHUPH20
Määrätty annos tiettyinä päivinä
Lääke: Nivolumabi + Relatlimabi
Määrätty annos tiettyinä päivinä
Muut nimet:
  • BMS-986213
  • Opdualag
Active Comparator: Nivolumabi + Relatlimab FDC IV
Lääke: Nivolumabi + Relatlimabi
Määrätty annos tiettyinä päivinä
Muut nimet:
  • BMS-986213
  • Opdualag

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Objective Response Rate (ORR) by BICR
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Bristol-Myers Squibb

Yhteistyökumppanit

Halozyme Therapeutics

Tutkijat

  • Opintojohtaja: Bristol-Myers Squibb, Bristol-Myers Squibb

Julkaisuja ja hyödyllisiä linkkejä

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Hyödyllisiä linkkejä

Opintojen ennätyspäivät

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Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Maanantai 6. maaliskuuta 2023

Ensisijainen valmistuminen (Todellinen)

Maanantai 4. elokuuta 2025

Opintojen valmistuminen (Arvioitu)

Torstai 18. marraskuuta 2027

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 15. marraskuuta 2022

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 15. marraskuuta 2022

Ensimmäinen Lähetetty (Todellinen)

Tiistai 22. marraskuuta 2022

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 26. elokuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 3. elokuuta 2026

Viimeksi vahvistettu

Lauantai 1. elokuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

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

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Katso suunnitelman kuvaus

IPD-jaon käyttöoikeuskriteerit

Katso suunnitelman kuvaus

IPD-jakamista tukeva tietotyyppi

  • STUDY_PROTOCOL
  • MAHLA
  • CSR

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