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Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
Study Purpose
The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.
Recruitment Criteria
|
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
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:
- - Had a negative sentinel lymph node biopsy.
- - Participant has not been previously treated for melanoma.
- - ECOG 0 or 1.
- - Participants must have been diagnosed with histologically confirmed, Resected, Stage IIB/C cutaneous melanoma.
Exclusion Criteria:
- - History of ocular or mucosal melanoma.
- - Pregnant or nursing women.
- - Participants with active known or suspected autoimmune disease.
- - Known history of allergy or hypersensitivity to study drug components.
- - Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or agents that target IL-2 pathways, T-cell stimulators, or checkpoint pathways.
Trial Details
|
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. |
NCT04099251 |
|
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, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Romania, 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
Placebo Comparator: Placebo
Interventions
Biological: - Nivolumab
Specified dose on specified days
Other: - Placebo
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 - 0088
Birmingham 4049979, Alabama 4829764, 35294-3300
Status
Address
Local Institution - 0126
Tucson 5318313, Arizona 5551752, 85724-5024
Status
Address
Local Institution - 0087
Springdale 4132093, Arkansas 4099753, 72762
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Local Institution - 0080
Los Angeles 5368361, California 5332921, 90025
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Local Institution - 0077
San Francisco 5391959, California 5332921, 94115
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Local Institution - 0119
San Francisco 5391959, California 5332921, 94115
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Local Institution - 0122
San Jose 5392171, California 5332921, 95119
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Local Institution - 0121
Vallejo 5405380, California 5332921, 94589-2441
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Local Institution - 0109
Vallejo 5405380, California 5332921, 94589
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Local Institution - 0120
Vallejo 5405380, California 5332921, 94589
Status
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Local Institution - 0091
Aurora 5412347, Colorado 5417618, 80045
Status
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Local Institution - 0089
Washington D.C. 4140963, District of Columbia 4138106, 20057
Status
Address
Local Institution - 0141
Atlanta 4180439, Georgia 4197000, 30342
Status
Address
Local Institution - 0132
Chicago 4887398, Illinois 4896861, 60611
Status
Address
Local Institution - 0135
Baltimore 4347778, Maryland 4361885, 21237
Status
Address
Local Institution - 0078
Boston 4930956, Massachusetts 6254926, 02215
Status
Address
Local Institution - 0127
Boston 4930956, Massachusetts 6254926, 02215
Status
Address
Local Institution - 0143
Boston 4930956, Massachusetts 6254926, 02215
Status
Address
Local Institution - 0151
Minneapolis 5037649, Minnesota 5037779, 55407
Status
Address
Local Institution - 0081
Robbinsdale 5043439, Minnesota 5037779, 55407
Status
Address
Local Institution - 0079
Omaha 5074472, Nebraska 5073708, 68130
Status
Address
Local Institution - 0093
Hackensack 5098706, New Jersey 5101760, 07601
Status
Address
Local Institution - 0094
New York 5128581, New York 5128638, 10016
Status
Address
Local Institution - 0086
Charlotte 4460243, North Carolina 4482348, 28204
Status
Address
Local Institution - 0099
Cleveland 5150529, Ohio 5165418, 44195
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Address
Local Institution - 0076
Portland 5746545, Oregon 5744337, 97213
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Address
Local Institution - 0092
Allentown 5178127, Pennsylvania 6254927, 18103
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Address
Local Institution - 0031
Pittsburgh 5206379, Pennsylvania 6254927, 15232
Status
Address
Local Institution - 0148
Germantown 4624601, Tennessee 4662168, 38138
Status
Address
Local Institution - 0144
Austin 4671654, Texas 4736286, 78731
Status
Address
Local Institution - 0085
Dallas 4684888, Texas 4736286, 75246
Status
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Local Institution - 0090
Fairfax 4758023, Virginia 6254928, 22031
International Sites
Status
Address
Local Institution - 0018
Waratah 10103871, New South Wales 2155400, 2298
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Address
Local Institution - 0025
Westmead 2143973, New South Wales 2155400, 2145
Status
Address
Local Institution - 0016
Wollstonecraft 9972972, New South Wales 2155400, 2065
Status
Address
Local Institution - 0105
Cairns 2172797, Queensland 2152274, 4870
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Local Institution - 0017
Greenslopes 9957342, Queensland 2152274, 4120
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Local Institution - 0024
Herston 6931014, Queensland 2152274, 4029
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Local Institution - 0138
Southport 2148928, Queensland 2152274, 4120
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Local Institution - 0019
Box Hill 2174360, Victoria 2145234, 3128
Status
Address
Local Institution - 0125
Geelong 2165798, Victoria 2145234, 3220
Status
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Local Institution - 0128
Malvern 2158952, Victoria 2145234, 3144
Status
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Local Institution - 0106
Melbourne 2158177, Victoria 2145234, 3004
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Local Institution - 0104
Nedlands 2064874, Western Australia 2058645, 6009
Status
Address
Local Institution - 0049
Graz 2778067, , 8036
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Local Institution - 0051
Innsbruck 2775220, , 6020
Status
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Local Institution - 0050
Salzburg 2766824, , 5020
Status
Address
Local Institution - 0048
Vienna 2761369, , 1090
Status
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Local Institution - 0028
Charleroi 2800481, , 6000
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Local Institution - 0011
Ghent 2797656, , 9000
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Local Institution - 0008
Kortrijk 2794055, , 8500
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Local Institution - 0010
Liège 2792413, , 4000
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Local Institution - 0134
Calgary 5913490, Alberta 5883102, T2N 4N2
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Address
Local Institution - 0133
Vancouver 6173331, British Columbia 5909050, V5Z 4E6
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Local Institution - 0131
Halifax 6324729, Nova Scotia 6091530, B3H 2Y9
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Local Institution - 0142
Hamilton 5969782, Ontario 6093943, L8V 5C2
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Local Institution - 0124
Kingston 5992500, Ontario 6093943, K7L 2V7
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Address
Local Institution - 0140
Toronto 6167865, Ontario 6093943, M5G 2M9
Status
Address
Local Institution - 0116
Montreal 6077243, Quebec 6115047, H2X 3E4
Status
Address
Local Institution - 0123
Sherbrooke 6146143, Quebec 6115047, J1H 5N4
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Address
Local Institution - 0074
Prague 3067696, Praha 2, 12808
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Address
Local Institution - 0075
Ostrava-Poruba, , 708 52
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Address
Local Institution - 0073
Prague 3067696, , 100 34
Status
Address
Local Institution - 0007
Aarhus N 11746890, , 8200
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Address
Local Institution - 0012
Herlev 2620431, , 2730
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Address
Local Institution - 0013
Odense 2615876, , 5000
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Address
Local Institution - 0014
Helsinki 658225, Etelä-Suomen Lääni, 00290
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Address
Local Institution - 0015
Tampere 634963, Pirkanmaa 830704, 33520
Status
Address
Local Institution - 0110
Turku 633679, , 20251
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Local Institution - 0113
Brest 3030300, Finistère, 29200
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Local Institution - 0129
Besançon 3033123, , 25030
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Address
Local Institution - 0112
Bordeaux 3031582, , 33075
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Local Institution - 0111
Lille 2998324, , 59037
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Local Institution - 0033
Marseille 2995469, , 13011
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Local Institution - 0035
Nantes 2990969, , 44000
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Local Institution - 0130
Nice 2990440, , 06200
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Local Institution - 0036
Paris 2988507, , 75475
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Local Institution - 0032
Pierre-Bénite 2987314, , 69495
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Local Institution - 0034
Villejuif 2968705, , 94800
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Local Institution - 0056
München 2867713, Bavaria 2951839, 81377
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Local Institution - 0072
Bonn 2946447, , 53127
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Local Institution - 0061
Buxtehude 2940451, , 21614
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Local Institution - 0098
Dresden 2935022, , 01307
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Local Institution - 0054
Essen 2928810, , 45122
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Local Institution - 0062
Gera 2921232, , 07548
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Local Institution - 0114
Göttingen 2918632, , 37075
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Local Institution - 0060
Hanover 2910831, , 30625
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Local Institution - 0055
Heidelberg 2907911, , 69120
Status
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Local Institution - 0057
Lübeck 2875601, , 23538
Status
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Local Institution - 0100
Mainz 2874225, , 55131
Status
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Local Institution - 0102
Regensburg 2849483, , 93053
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Local Institution - 0058
Tübingen 2820860, , 72076
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Local Institution - 0084
Athens 264371, Attikí, 185 47
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Local Institution - 0082
Athens 264371, , 115 27
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Local Institution - 0083
Thessaloniki 734077, , 57100
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Local Institution - 0046
Palermo 2523920, Sicily 2523119, 90127
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Local Institution - 0040
Bergamo 3182164, , 24127
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Local Institution - 0037
Milan 6951411, , 20133
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Local Institution - 0146
Milan 6951411, , 20141
Status
Address
Local Institution - 0101
Napoli 9031661, , 80131
Status
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Local Institution - 0039
Padua 3171728, , 35128
Status
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Local Institution - 0145
Perugia 3171180, , 06132
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Local Institution - 0038
Siena 3166548, , 53100
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Local Institution - 0107
Breda 2758401, , 4819 EV
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Local Institution - 0001
Groningen 2755251, , 9700RB
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Local Institution - 0030
Rotterdam 2747891, , 3015 AA
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Local Institution - 0002
Utrecht 2745912, , 3584 CX
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Local Institution - 0063
Bergen 3161732, , 5021
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Address
Local Institution - 0027
Grålum 9404106, , 1714
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Local Institution - 0005
Oslo 3143244, , 0310
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Local Institution - 0103
Poznan 3088171, Greater Poland Voivodeship 3337498, 60-569
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Local Institution - 0023
Gdansk 3099434, , 80-214
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Local Institution - 0022
Warsaw 756135, , 02-781
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Local Institution - 0047
Cluj-Napoca 681290, , 400015
Status
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Local Institution - 0020
Craiova 680332, , 200542
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Address
Local Institution - 0021
Sector 2 11048318, , 022328
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Local Institution - 0071
Barcelona 3128760, Barcelona [Barcelona], 08028
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Address
Local Institution - 0067
A Coruña 3119841, , 15006
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Address
Local Institution - 0065
Badalona 3129028, , 08916
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Local Institution - 0066
Madrid 3117735, , 28034
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Local Institution - 0070
Madrid 3117735, , 28046
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Address
Local Institution - 0068
Málaga 2514256, , 29010
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Address
Local Institution - 0064
Santander 3109718, , 39008
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Local Institution - 0069
Valencia 2509954, , 46009
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Local Institution - 0026
Örebro 2686657, , 701 85
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Address
Local Institution - 0003
Linköping 2694762, Östergötlands Län [se-05], 581 85
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Address
Local Institution - 0053
Lausanne 2659994, , 1011
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Address
Local Institution - 0052
Zurich 2657896, , 8091
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Address
Local Institution - 0044
Cardiff 2653822, , CF14 2TL
Status
Address
Local Institution - 0095
Southampton 2637487, , SO16 6YD
