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A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
Study Purpose
The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 12 Years and Over |
| Gender | All |
Inclusion Criteria.
- - Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to < 18 years of age).
- - Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system.
- - Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- - Participants must be ≥ 12 years of age.
- - Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition).
- - Participants must not have ocular melanoma.
- - Participants must not have a history of myocarditis, regardless of etiology.
- - Participants must not have a condition requiring systemic treatment with either corticosteroids (>10 milligrams [mg] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment.
- - Other protocol-defined Inclusion/Exclusion criteria apply.
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05625399 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Bristol-Myers Squibb |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Bristol-Myers Squibb |
| Principal Investigator Affiliation | Bristol-Myers Squibb |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Active, not recruiting |
| Countries | Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Finland, France, Germany, Israel, Italy, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Melanoma |
| Study Website: | View Trial Website |
Arms
Experimental: Nivolumab + Relatlimab FDC SC
Active Comparator: Nivolumab + Relatlimab FDC IV
Interventions
Drug: - Nivolumab + Relatlimab
Specified dose on specified days
Drug: - rHuPH20
Specified dose on specified days
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
Local Institution - 0125
Phoenix, Arizona, 85013
Status
Address
Local Institution - 0189
Springdale, Arkansas, 72762
Status
Address
Local Institution - 0098
Los Angeles, California, 90025
Status
Address
Local Institution - 0093
Orange, California, 92868-3201
Status
Address
Local Institution - 0123
Stanford, California, 94305
Status
Address
Local Institution - 0113
Englewood, Colorado, 80113
Status
Address
Local Institution - 0114
Jacksonville, Florida, 32224
Status
Address
Local Institution - 0146
Baltimore, Maryland, 21201
Status
Address
Local Institution - 0071
Rochester, Minnesota, 55905
Status
Address
Local Institution - 0013
Omaha, Nebraska, 68130
Status
Address
Local Institution - 0169
Cleveland, Ohio, 44195
Status
Address
Local Institution - 0139
Easton, Pennsylvania, 18045
Status
Address
Local Institution - 0124
Philadelphia, Pennsylvania, 19107
Status
Address
Local Institution - 0122
Murray, Utah, 84107
Status
Address
Local Institution - 0115
Fairfax, Virginia, 22031
International Sites
Status
Address
Local Institution - 0050
Coffs Harbour, New South Wales, 2450
Status
Address
Local Institution - 0175
Orange, New South Wales, 2800
Status
Address
Local Institution - 0172
Port Macquarie, New South Wales, 2444
Status
Address
Local Institution - 0118
Wagga Wagga, New South Wales, 2650
Status
Address
Local Institution - 0184
Waratah, New South Wales, 2298
Status
Address
Local Institution - 0033
Westmead, New South Wales, 2145
Status
Address
Local Institution - 0055
Wollstonecraft, New South Wales, 2065
Status
Address
Local Institution - 0090
Birtinya, Queensland, 4575
Status
Address
Local Institution - 0008
Bendigo, Victoria, 3550
Status
Address
Local Institution - 0059
Box Hill, Victoria, 3128
Status
Address
Local Institution - 0154
Heidelberg, Victoria, 3084
Status
Address
Local Institution - 0030
Melbourne, Victoria, 3004
Status
Address
Local Institution - 0109
Traralgon, Victoria, 3844
Status
Address
Local Institution - 0106
Nedlands, Western Australia, 6009
Status
Address
Local Institution - 0161
Nedlands, Western Australia, 6009
Status
Address
Local Institution - 0027
Graz, , 8036
Status
Address
Local Institution - 0029
Salzburg, , 5020
Status
Address
Local Institution - 0168
St. Polten, , 3100
Status
Address
Local Institution - 0037
Wien, , 1090
Status
Address
Local Institution - 0072
Brussels, , 1200
Status
Address
Local Institution - 0078
Charleroi, , 6000
Status
Address
Local Institution - 0016
Liege, , 4000
Status
Address
Local Institution - 0177
Fortaleza, Ce, 60135237
Status
Address
Local Institution - 0180
Vitoria, ES, 29043-260
Status
Address
Local Institution - 0107
Belo Horizonte, Minas Gerais, 30130-090
Status
Address
Local Institution - 0025
Ijui, Rio Grande Do Sul, 98700-000
Status
Address
Local Institution - 0002
Porto Alegrelegre, RIO Grande DO SUL, 91350-250
Status
Address
Local Institution - 0031
Porto Alegre, RIO Grande DO SUL, 90035-903
Status
Address
Local Institution - 0058
Porto Alegre, Rio Grande Do Sul, 90610-000
Status
Address
Local Institution - 0009
Barretos, Sao Paulo, 14784-400
Status
Address
Local Institution - 0018
Sao Jose do Rio Preto, Sao Paulo, 15090-000
Status
Address
Local Institution - 0159
Blumenau, SC, 89010-340
Status
Address
Local Institution - 0110
Rio De Janeiro, , 20220-410
Status
Address
Local Institution - 0130
Sao Paulo, , 01321-001
Status
Address
Local Institution - 0141
Calgary, Alberta, T2N 5G2
Status
Address
Local Institution - 0121
Hamilton, Ontario, L8V 5C2
Status
Address
Local Institution - 0096
Ottawa, Ontario, K1H 8L6
Status
Address
Local Institution - 0116
Toronto, Ontario, M4N 3M5
Status
Address
Local Institution - 0103
Quebec, , G1J 1Z4
Status
Address
Local Institution - 0143
Temuco, Araucania, 4800827
Status
Address
Local Institution - 0178
Puerto Montt, Los Lagos, 5507642
Status
Address
Local Institution - 0140
Recoleta, Metropolitana, 8380455
Status
Address
Local Institution - 0144
Santiago, Metropolitana, 0101010
Status
Address
Local Institution - 0010
Santiago, Metropolitana, 7510032
Status
Address
Local Institution - 0074
Santiago, Metropolitana, 8150513
Status
Address
Local Institution - 0119
Santiago de Chile, Providencia, 7500653
Status
Address
Local Institution - 0028
Vina Del Mar, Valparaiso, 2520598
Status
Address
Local Institution - 0017
Santiago, , 7500921
Status
Address
Local Institution - 0083
Prague, NY, 128 00
Status
Address
Local Institution - 0094
Hradec Kralove, , 500 05
Status
Address
Local Institution - 0091
Olomouc, , 77900
Status
Address
Local Institution - 0082
Ostrava Poruba, , 708 52
Status
Address
Local Institution - 0095
Prague, , 182 00
Status
Address
Local Institution - 0164
Helsinki, , 00029
Status
Address
Local Institution - 0167
Tampere, , 33521
Status
Address
Local Institution - 0162
Turku, , 20520
Status
Address
Local Institution - 0108
Toulouse, Cedex 9, 31059
Status
Address
Local Institution - 0034
Paris, Ile De France, 75475
Status
Address
Local Institution - 0127
Chambray-les-Tours, Indre-Et-Loire, 37044
Status
Address
Local Institution - 0111
Lille, Nord, 59000
Status
Address
Local Institution - 0063
Nantes Cedex 01, OH, 44093
Status
Address
Local Institution - 0061
Villejuif Cedex, Val-De-Marne, 94805
Status
Address
Local Institution - 0007
Amiens, , 80054
Status
Address
Local Institution - 0128
Bayonne, , 64100
Status
Address
Local Institution - 0022
Bordeaux, , 33000
Status
Address
Local Institution - 0129
Clermont Ferrand Cedex 1, , 63003
Status
Address
Local Institution - 0046
Dijon, , 21079
Status
Address
Local Institution - 0117
Marseille, , 13385
Status
Address
Local Institution - 0052
Pierre-Benite, , 69310
Status
Address
Local Institution - 0089
Rennes Cedex, , 35042
Status
Address
Local Institution - 0099
Rouen, , 76031
Status
Address
Local Institution - 0101
Heidelberg, Baden-Wurttemberg, 69120
Status
Address
Local Institution - 0079
Ulm, Baden-Wurttemberg, 89081
Status
Address
Local Institution - 0011
Regensburg, Bayern, 93042
Status
Address
Local Institution - 0003
Luebeck, Schleswig-Holstein, 23538
Status
Address
Local Institution - 0060
Berlin, , 10117
Status
Address
Local Institution - 0038
Buxtehude, , 21614
Status
Address
Local Institution - 0136
Dortmund, , 44137
Status
Address
Local Institution - 0039
Erfurt, , 99089
Status
Address
Local Institution - 0049
Essen, , 45147
Status
Address
Local Institution - 0166
Frankfurt am Main, , 60590
Status
Address
Local Institution - 0065
Giessen, , 35385
Status
Address
Local Institution - 0135
Goettingen, , 37075
Status
Address
Local Institution - 0138
Hamburg, , 20251
Status
Address
Local Institution - 0137
Ludwigshafen, , 67063
Status
Address
Local Institution - 0165
Marburg, , 35043
Status
Address
Local Institution - 0044
Minden, , 32429
Status
Address
Local Institution - 0112
Nuernberg, , 90419
Status
Address
Local Institution - 0053
Rostock, , 18057
Status
Address
Local Institution - 0081
Tuebingen, , 72076
Status
Address
Local Institution - 0026
Afula, , 1834111
Status
Address
Local Institution - 0054
Jerusalem, , 9112001
Status
Address
Local Institution - 0102
Petah-Tikvah, , 4941492
Status
Address
Local Institution - 0035
Tel Hashomer, , 5262100
Status
Address
Local Institution - 0173
Tel-Aviv, , 6423906
Status
Address
Local Institution - 0051
Bari, , 70124
Status
Address
Local Institution - 0077
Genova, , 16132
Status
Address
Local Institution - 0170
Milan, , 20133
Status
Address
Local Institution - 0084
Napoli, , 80131
Status
Address
Local Institution - 0032
Perugia, , 06132
Status
Address
Local Institution - 0064
Roma, , 00168
Status
Address
Local Institution - 0014
Siena, , 53100
Status
Address
Local Institution - 0163
Bodo, , 8005
Status
Address
Local Institution - 0156
Gralum, , 1714
Status
Address
Local Institution - 0158
Lørenskog, , 1474
Status
Address
Local Institution - 0155
Oslo, , 0379
Status
Address
Local Institution - 0171
Bydgoszcz, Kujawsko-pomorskie, 85-796
Status
Address
Local Institution - 0021
Krakow, Malopolskie, 30727
Status
Address
Local Institution - 0005
Opole, Opolskie, 45-061
Status
Address
Local Institution - 0015
Poznan, Wiekopolskie, 60-780
Status
Address
Local Institution - 0066
Warszawa, , 02-781
Status
Address
Local Institution - 0012
Donostia, Gipuzkoa, 20014
Status
Address
Local Institution - 0086
A Coruna, , 15006
Status
Address
Local Institution - 0134
Badalona, , 08916
Status
Address
Local Institution - 0047
Barcelona, , 08035
Status
Address
Local Institution - 0024
Barcelona, , 08036
Status
Address
Local Institution - 0153
Jaen, , 23007
Status
Address
Local Institution - 0045
Las Palmas de Gran Canaria, , 35016
Status
Address
Local Institution - 0040
Madrid, , 28007
Status
Address
Local Institution - 0126
Madrid, , 28009
Status
Address
Local Institution - 0004
Madrid, , 28041
Status
Address
Local Institution - 0056
Madrid, , 28050
Status
Address
Local Institution - 0006
Sevilla, , 41009
Status
Address
Local Institution - 0041
Valencia, , 46009
Status
Address
Local Institution - 0043
Valencia, , 46009
Status
Address
Local Institution - 0151
Valencia, , 46014
Status
Address
Local Institution - 0062
Solna, Stockholm, 171 64
Status
Address
Local Institution - 0097
Lund, , 222 42
Status
Address
Local Institution - 0092
Bern, , 3010
Status
Address
Local Institution - 0080
Chur, , 7000
Status
Address
Local Institution - 0105
Lausanne, , 1011
Status
Address
Local Institution - 0088
London, Greater London, SW3 6JJ
Status
Address
Local Institution - 0068
Headington, Oxford, Oxfordshire, OX3 7LE
Status
Address
Local Institution - 0120
Newcastle Upon Tyne, Tyne And Wear, NE7 7DN
