이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

이전에 치료받지 않은 전이성 또는 절제 불가능한 흑색종에서 피하 Nivolumab + Relatlimab 고정 용량 조합(FDC)에 대한 연구 (RELATIVITY-127)

2026년 8월 3일 업데이트: Bristol-Myers Squibb

이전에 치료받지 않은 전이성 또는 절제 불가능한 흑색종 환자를 대상으로 피하 Nivolumab + Relatlimab 고정 용량 조합 대 정맥 주사 Nivolumab + Relatlimab 고정 용량 조합의 3상, 무작위, 공개 라벨 연구

이 연구의 목적은 니볼루맙 + 렐라틀리맙 FDC 피하(SC) 제형의 연구 약물 노출 수준이 이전에 치료받지 않은 전이성 또는 절제 불가능한 흑색종을 가진 참가자에서 니볼루맙 + 렐라틀리맙 FDC 정맥내(IV) 투여보다 나쁘지 않음을 입증하는 것입니다.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

579

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 노르웨이
      • Bodø, 노르웨이, 8005
        • Local Institution - 0163
      • Grålum, 노르웨이, 1714
        • Local Institution - 0156
      • Lørenskog, 노르웨이, 1474
        • Local Institution - 0158
      • Oslo, 노르웨이, 0379
        • Local Institution - 0155
  • 독일
      • Berlin, 독일, 10117
        • Local Institution - 0060
      • Buxtehude, 독일, 21614
        • Local Institution - 0038
      • Dortmund, 독일, 44137
        • Local Institution - 0136
      • Erfurt, 독일, 99089
        • Local Institution - 0039
      • Essen, 독일, 45147
        • Local Institution - 0049
      • Frankfurt am Main, 독일, 60590
        • Local Institution - 0166
      • Giessen, 독일, 35385
        • Local Institution - 0065
      • Göttingen, 독일, 37075
        • Local Institution - 0135
      • Hamburg, 독일, 20251
        • Local Institution - 0138
      • Ludwigshafen, 독일, 67063
        • Local Institution - 0137
      • Marburg, 독일, 35043
        • Local Institution - 0165
      • Minden, 독일, 32429
        • Local Institution - 0044
      • Nuremberg, 독일, 90419
        • Local Institution - 0112
      • Rostock, 독일, 18057
        • Local Institution - 0053
      • Tübingen, 독일, 72076
        • Local Institution - 0081
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, 독일, 69120
        • Local Institution - 0101
      • Ulm, Baden-Wurttemberg, 독일, 89081
        • Local Institution - 0079
    • Bavaria
      • Regensburg, Bavaria, 독일, 93042
        • Local Institution - 0011
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, 독일, 23538
        • Local Institution - 0003
  • 미국
    • Arizona
      • Phoenix, Arizona, 미국, 85013
        • Local Institution - 0125
    • Arkansas
      • Springdale, Arkansas, 미국, 72762
        • Local Institution - 0189
    • California
      • Los Angeles, California, 미국, 90025
        • Local Institution - 0098
      • Orange, California, 미국, 92868-3201
        • Local Institution - 0093
      • Stanford, California, 미국, 94305
        • Local Institution - 0123
    • Colorado
      • Englewood, Colorado, 미국, 80113
        • Local Institution - 0113
    • Florida
      • Jacksonville, Florida, 미국, 32224
        • Local Institution - 0114
    • Maryland
      • Baltimore, Maryland, 미국, 21201
        • Local Institution - 0146
    • Minnesota
      • Rochester, Minnesota, 미국, 55905
        • Local Institution - 0071
    • Nebraska
      • Omaha, Nebraska, 미국, 68130
        • Local Institution - 0013
    • Ohio
      • Cleveland, Ohio, 미국, 44195
        • Local Institution - 0169
    • Pennsylvania
      • Easton, Pennsylvania, 미국, 18045
        • Local Institution - 0139
      • Philadelphia, Pennsylvania, 미국, 19107
        • Local Institution - 0124
    • Utah
      • Murray, Utah, 미국, 84107
        • Local Institution - 0122
    • Virginia
      • Fairfax, Virginia, 미국, 22031
        • Local Institution - 0115
  • 벨기에
      • Brussels, 벨기에, 1200
        • Local Institution - 0072
      • Charleroi, 벨기에, 6000
        • Local Institution - 0078
      • Liège, 벨기에, 4000
        • Local Institution - 0016
  • 브라질
    • Ceará
      • Fortaleza, Ceará, 브라질, 60135237
        • Local Institution - 0177
    • Espírito Santo
      • Vitória, Espírito Santo, 브라질, 29043-260
        • Local Institution - 0180
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, 브라질, 30130-090
        • Local Institution - 0107
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, 브라질, 98700-000
        • Local Institution - 0025
      • Porto Alegre, Rio Grande do Sul, 브라질, 90035-903
        • Local Institution - 0031
      • Porto Alegre, Rio Grande do Sul, 브라질, 90610-000
        • Local Institution - 0058
      • Porto Alegrelegre, Rio Grande do Sul, 브라질, 91350-250
        • Local Institution - 0002
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, 브라질, 20220-410
        • Local Institution - 0110
    • Santa Catarina
      • Blumenau, Santa Catarina, 브라질, 89010-340
        • Local Institution - 0159
    • São Paulo
      • Barretos, São Paulo, 브라질, 14784-400
        • Local Institution - 0009
      • São José do Rio Preto, São Paulo, 브라질, 15090-000
        • Local Institution - 0018
      • São Paulo, São Paulo, 브라질, 01321-001
        • Local Institution - 0130
  • 스웨덴
      • Lund, 스웨덴, 222 42
        • Local Institution - 0097
    • Stockholm County
      • Solna, Stockholm County, 스웨덴, 171 64
        • Local Institution - 0062
  • 스위스
      • Bern, 스위스, 3010
        • Local Institution - 0092
      • Chur, 스위스, 7000
        • Local Institution - 0080
      • Lausanne, 스위스, 1011
        • Local Institution - 0105
  • 스페인
      • Badalona, 스페인, 08916
        • Local Institution - 0134
      • Barcelona, 스페인, 08036
        • Local Institution - 0024
      • Las Palmas de Gran Canaria, 스페인, 35016
        • Local Institution - 0045
      • Madrid, 스페인, 28007
        • Local Institution - 0040
      • Madrid, 스페인, 28050
        • Local Institution - 0056
      • Seville, 스페인, 41009
        • Local Institution - 0006
      • Valencia, 스페인, 46014
        • Local Institution - 0151
      • Valencia, 스페인, 46009
        • Local Institution - 0043
    • A Coruna
      • A Coruña, A Coruna, 스페인, 15006
        • Local Institution - 0086
    • Barcelona
      • Barcelona, Barcelona, 스페인, 08035
        • Local Institution - 0047
    • Gipuzkoa
      • Donostia / San Sebastian, Gipuzkoa, 스페인, 20014
        • Local Institution - 0012
    • Jaen
      • Jaén, Jaen, 스페인, 23007
        • Local Institution - 0153
    • Madrid
      • Madrid, Madrid, 스페인, 28009
        • Local Institution - 0126
      • Madrid, Madrid, 스페인, 28041
        • Local Institution - 0004
    • Valencia
      • Valencia, Valencia, 스페인, 46009
        • Local Institution - 0041
  • 영국
    • Greater London
      • London, Greater London, 영국, SW3 6JJ
        • Local Institution - 0088
    • Oxfordshire
      • Headington, Oxford, Oxfordshire, 영국, OX3 7LE
        • Local Institution - 0068
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, 영국, NE7 7DN
        • Local Institution - 0120
  • 오스트리아
      • Graz, 오스트리아, 8036
        • Local Institution - 0027
      • Salzburg, 오스트리아, 5020
        • Local Institution - 0029
      • Sankt Pölten, 오스트리아, 3100
        • Local Institution - 0168
      • Vienna, 오스트리아, 1090
        • Local Institution - 0037
  • 이스라엘
      • Afula, 이스라엘, 1834111
        • Local Institution - 0026
      • Petah-Tikvah, 이스라엘, 4941492
        • Local Institution - 0102
      • Tel Aviv, 이스라엘, 6423906
        • Local Institution - 0173
      • Tel Litwinsky, 이스라엘, 5262100
        • Local Institution - 0035
    • Israel
      • Jerusalem, Israel, 이스라엘, 9112001
        • Local Institution - 0054
  • 이탈리아
      • Bari, 이탈리아, 70124
        • Local Institution - 0051
      • Milan, 이탈리아, 20133
        • Local Institution - 0170
      • Naples, 이탈리아, 80131
        • Local Institution - 0084
      • Perugia, 이탈리아, 06132
        • Local Institution - 0032
      • Roma, 이탈리아, 00168
        • Local Institution - 0064
    • Genova
      • Genova, Genova, 이탈리아, 16132
        • Local Institution - 0077
    • Siena
      • Siena, Siena, 이탈리아, 53100
        • Local Institution - 0014
  • 체코
      • Hradec Králové, 체코, 500 05
        • Local Institution - 0094
      • Olomouc, 체코, 77900
        • Local Institution - 0091
      • Ostrava Poruba, 체코, 708 52
        • Local Institution - 0082
      • Prague, 체코, 182 00
        • Local Institution - 0095
    • NY
      • Prague, NY, 체코, 128 00
        • Local Institution - 0083
  • 칠레
      • Santiago, 칠레, 7500921
        • Local Institution - 0017
    • Araucania
      • Temuco, Araucania, 칠레, 4800827
        • Local Institution - 0143
    • Los Lagos Region
      • Port Montt, Los Lagos Region, 칠레, 5507642
        • Local Institution - 0178
    • Providencia
      • Santiago, Providencia, 칠레, 7500653
        • Local Institution - 0119
    • Santiago Metropolitan
      • Recoleta, Santiago Metropolitan, 칠레, 8380455
        • Local Institution - 0140
      • Santiago, Santiago Metropolitan, 칠레, 0101010
        • Local Institution - 0144
      • Santiago, Santiago Metropolitan, 칠레, 7510032
        • Local Institution - 0010
      • Santiago, Santiago Metropolitan, 칠레, 8150513
        • Local Institution - 0074
    • Valparaiso
      • Viña del Mar, Valparaiso, 칠레, 2520598
        • Local Institution - 0028
  • 캐나다
    • Alberta
      • Calgary, Alberta, 캐나다, T2N 5G2
        • Local Institution - 0141
    • Ontario
      • Hamilton, Ontario, 캐나다, L8V 5C2
        • Local Institution - 0121
      • Ottawa, Ontario, 캐나다, K1H 8L6
        • Local Institution - 0096
      • Toronto, Ontario, 캐나다, M4N 3M5
        • Local Institution - 0116
    • Quebec
      • Québec, Quebec, 캐나다, G1J 1Z4
        • Local Institution - 0103
  • 폴란드
      • Warsaw, 폴란드, 02-781
        • Local Institution - 0066
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 폴란드, 85-796
        • Local Institution - 0171
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, 폴란드, 30727
        • Local Institution - 0021
    • Opole Voivodeship
      • Opole, Opole Voivodeship, 폴란드, 45-061
        • Local Institution - 0005
    • Wiekopolskie
      • Poznan, Wiekopolskie, 폴란드, 60-780
        • Local Institution - 0015
  • 프랑스
      • Amiens, 프랑스, 80054
        • Local Institution - 0007
      • Bayonne, 프랑스, 64100
        • Local Institution - 0128
      • Bordeaux, 프랑스, 33000
        • Local Institution - 0022
      • Clermont-Ferrand, 프랑스, 63003
        • Local Institution - 0129
      • Dijon, 프랑스, 21079
        • Local Institution - 0046
      • Marseille, 프랑스, 13385
        • Local Institution - 0117
      • Pierre-Bénite, 프랑스, 69310
        • Local Institution - 0052
      • Rennes, 프랑스, 35042
        • Local Institution - 0089
      • Rouen, 프랑스, 76031
        • Local Institution - 0099
    • Cedex 9
      • Toulouse, Cedex 9, 프랑스, 31059
        • Local Institution - 0108
    • Indre-Et-Loire
      • Chambray-lès-Tours, Indre-Et-Loire, 프랑스, 37044
        • Local Institution - 0127
    • Nord
      • Lille, Nord, 프랑스, 59000
        • Local Institution - 0111
    • OH
      • Nantes, OH, 프랑스, 44093
        • Local Institution - 0063
    • Val-De-Marne
      • Villejuif, Val-De-Marne, 프랑스, 94805
        • Local Institution - 0061
    • Île-de-France Region
      • Paris, Île-de-France Region, 프랑스, 75475
        • Local Institution - 0034
  • 핀란드
      • Helsinki, 핀란드, 00029
        • Local Institution - 0164
      • Tampere, 핀란드, 33521
        • Local Institution - 0167
      • Turku, 핀란드, 20520
        • Local Institution - 0162
  • 호주
    • New South Wales
      • Coffs Harbour, New South Wales, 호주, 2450
        • Local Institution - 0050
      • Orange, New South Wales, 호주, 2800
        • Local Institution - 0175
      • Port Macquarie, New South Wales, 호주, 2444
        • Local Institution - 0172
      • Wagga Wagga, New South Wales, 호주, 2650
        • Local Institution - 0118
      • Waratah, New South Wales, 호주, 2298
        • Local Institution - 0184
      • Westmead, New South Wales, 호주, 2145
        • Local Institution - 0033
      • Wollstonecraft, New South Wales, 호주, 2065
        • Local Institution - 0055
    • Queensland
      • Birtinya, Queensland, 호주, 4575
        • Local Institution - 0090
    • Victoria
      • Bendigo, Victoria, 호주, 3550
        • Local Institution - 0008
      • Box Hill, Victoria, 호주, 3128
        • Local Institution - 0059
      • Heidelberg, Victoria, 호주, 3084
        • Local Institution - 0154
      • Melbourne, Victoria, 호주, 3004
        • Local Institution - 0030
      • Traralgon, Victoria, 호주, 3844
        • Local Institution - 0109
    • Western Australia
      • Nedlands, Western Australia, 호주, 6009
        • Local Institution - 0106
      • Nedlands, Western Australia, 호주, 6009
        • Local Institution - 0161

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

12년 이상 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

  • 참가자는 청소년(≥ 12~< 18세)의 경우 동부 협력 종양학 그룹(ECOG) 수행 상태가 ≤ 1/Lansky 수행 점수 ≥ 80%여야 합니다.
  • 참가자는 AJCC(American Joint Committee for Cancer) 병기 결정 시스템에 따라 조직학적으로 확인된 III기(절제 불가) 또는 IV기(전이성) 흑색종이 있어야 합니다.
  • 참가자는 고형 종양 버전 1.1(RECIST v1.1)의 반응 평가 기준에 따라 컴퓨터 단층촬영(CT) 또는 자기공명영상(MRI)으로 측정 가능한 질병이 있어야 합니다.
  • 참가자는 12세 이상이어야 합니다. 12세 이상 18세 미만(청소년) 참가자는 정보에 입각한 동의(동의) 서명 시점에 체중이 40kg 이상이어야 합니다.
  • 참가자는 AJCC 병기 결정 시스템(8판)에 따라 조직학적으로 확인된 III기(절제 불가) 또는 IV기(전이성) 흑색종이 있어야 합니다.

제외 기준:

  • 참가자는 안구 흑색종이 없어야 합니다.
  • 참가자는 병인에 관계없이 심근염 병력이 없어야 합니다.
  • 참가자는 연구 치료 시작 14일 이내에 코르티코스테로이드(>10mg[mg] 일일 프레드니손 등가물) 또는 기타 면역억제제를 사용한 전신 치료가 필요한 상태가 아니어야 합니다. 흡입 또는 국소 스테로이드 및 부신 대체 스테로이드 용량 >10 mg 일일 프레드니손 등가물은 활동성 자가면역 질환이 없는 경우 허용됩니다.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 니볼루맙 + 렐라틀리맙 FDC SC
의약품: rHuPH20
지정된 요일에 지정된 복용량
의약품: 니볼루맙 + 렐라틀리맙
지정된 요일에 지정된 복용량
다른 이름들:
  • BMS-986213
  • 옵듀라그
활성 비교기: 니볼루맙 + 렐라틀리맙 FDC IV
의약품: 니볼루맙 + 렐라틀리맙
지정된 요일에 지정된 복용량
다른 이름들:
  • BMS-986213
  • 옵듀라그

연구는 무엇을 측정합니까?

주요 결과 측정

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

2차 결과 측정

결과 측정
측정값 설명
기간
Objective Response Rate (ORR) by BICR
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Bristol-Myers Squibb

협력자

Halozyme Therapeutics

수사관

  • 연구 책임자: Bristol-Myers Squibb, Bristol-Myers Squibb

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 3월 6일

기본 완료 (실제)

2025년 8월 4일

연구 완료 (추정된)

2027년 11월 18일

연구 등록 날짜

최초 제출

2022년 11월 15일

QC 기준을 충족하는 최초 제출

2022년 11월 15일

처음 게시됨 (실제)

2022년 11월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 3일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

BMS는 자격을 갖춘 연구원의 요청에 따라 특정 기준에 따라 개별 익명 참가자 데이터에 대한 액세스를 제공합니다. Bristol Myers Squibb의 데이터 공유 정책 및 프로세스에 대한 추가 정보는 https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html에서 확인할 수 있습니다.

IPD 공유 기간

계획 설명 참조

IPD 공유 액세스 기준

계획 설명 참조

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다