Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma
Study Purpose
The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.
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 | 15 Years and Over |
Gender | All |
Inclusion Criteria:
- - At least 15 years of age Except: where local regulations and/or institutional policies do not allow for subjects < 18 years of age (pediatric population) to participate.
- - Completely removed melanoma by surgery performed within 12 weeks of randomization.
- - Stage IIIb/C or Stage IV before complete resection.
- - No previous anti-cancer treatment.
Exclusion Criteria:
- - Ocular or uveal melanoma.
- - History of carcinomatosis meningitis.
- - History of auto-immune disease.
- - Treatment directed against the resected melanoma that is administrated after the surgery.
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. |
NCT02388906 |
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 | Argentina, Australia, Austria, Belgium, Canada, Czechia, Finland, France, Greece, Hungary, Ireland, Italy, Japan, Korea, Republic of, Netherlands, Norway, Poland, Romania, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Melanoma |
Study Website: | View Trial Website |
Arms
Experimental: Ipilimumab and Placebo matching Nivolumab
Experimental: Nivolumab and Placebo matching Ipilimumab
Interventions
Drug: - Ipilimumab
Specified dose on specified days
Drug: - Nivolumab
Specified dose on specified days
Other: - Placebo matching Ipilimumab
Specified dose on specified days
Other: - Placebo matching Nivolumab
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.
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Local Institution - 0036
Little Rock, Arkansas, 72205
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Local Institution - 0117
La Jolla, California, 92093-0698
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Local Institution - 0189
Los Angeles, California, 90025
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Local Institution - 0021
San Francisco, California, 94109
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Local Institution - 0006
San Francisco, California, 94143
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Local Institution - 0010
Aurora, Colorado, 80045
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Local Institution - 0004
Washington, District of Columbia, 20007
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Local Institution - 0012
Jacksonville, Florida, 32207
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Local Institution - 0019
Miami Beach, Florida, 33140
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Local Institution - 0030
Orlando, Florida, 32806
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Local Institution - 0032
Tampa, Florida, 33612
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Local Institution - 0016
Atlanta, Georgia, 30322
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Local Institution - 0106
Chicago, Illinois, 60637
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Local Institution - 0013
Boston, Massachusetts, 02215
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Local Institution - 0170
Boston, Massachusetts, 02215
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Local Institution - 0171
Boston, Massachusetts, 02215
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Local Institution - 0015
Ann Arbor, Michigan, 48109-5869
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Local Institution - 0002
Fridley, Minnesota, 55432
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Local Institution - 0017
Saint Louis, Missouri, 63110
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Local Institution - 0123
Hackensack, New Jersey, 07601
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Local Institution - 0095
New Brunswick, New Jersey, 08903
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Local Institution - 0024
New York, New York, 10016
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Local Institution - 0033
New York, New York, 10065
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Local Institution - 0003
Charlotte, North Carolina, 28204
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Local Institution - 0025
Durham, North Carolina, 27710
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Local Institution - 0157
Columbus, Ohio, 43210
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Local Institution - 0031
Portland, Oregon, 97213
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Local Institution - 0029
Portland, Oregon, 97239
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Local Institution - 0022
Allentown, Pennsylvania, 18103
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Local Institution - 0001
Bethlehem, Pennsylvania, 18015
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Local Institution - 0026
Charleston, South Carolina, 29425
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Local Institution - 0014
Nashville, Tennessee, 37203-1624
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Local Institution - 0005
Dallas, Texas, 75246
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Local Institution - 0027
Charlottesville, Virginia, 22908
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Local Institution - 0126
Seattle, Washington, 98109
International Sites
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Local Institution - 0142
Capital Federal, Buenos Aires, 1426
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Local Institution - 0140
San Miguel de Tucuman, Tucuman, 4000
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Local Institution
Cordoba, , 5000
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Local Institution - 0079
Gateshead, New South Wales, 2290
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Local Institution - 0080
Westmead, New South Wales, 2145
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Local Institution - 0078
Wollstonecraft, New South Wales, 2065
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Local Institution - 0082
Greenslopes, Queensland, 4120
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Local Institution - 0083
Southport, Queensland, 4215
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Local Institution - 0084
Adelaide, South Australia, 5000
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Local Institution - 0075
Heidelberg, Victoria, 3084
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Local Institution - 0077
Prahran, Victoria, 3181
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Local Institution - 0085
Nedlands, Western Australia, 6009
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Local Institution - 0081
Camperdown, , 2050
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Local Institution - 0169
Graz, , 8036
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Local Institution - 0168
Salzburg, , 5020
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Local Institution - 0038
Brussels, , 1090
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Local Institution - 0040
Bruxelles, , 1200
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Local Institution - 0037
Gent, , 9000
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Local Institution - 0039
Leuven, , 3000
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Local Institution - 0051
Edmonton, Alberta, T6G 1Z2
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Local Institution - 0074
Vancouver, British Columbia, V5Z 4E6
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Local Institution - 0094
Toronto, Ontario, M5G 2M9
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Local Institution - 0105
Montreal, Quebec, H3T 1E2
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Local Institution - 0046
Quebec City, Quebec, G1J 1Z4
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Local Institution - 0101
Hradec Kralove, , 500 05
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Local Institution - 0102
Ostrava-Poruba, , 708 52
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Local Institution - 0099
Praha 1, , 110 00
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Local Institution - 0100
Praha 2, , 128 08
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Local Institution - 0047
Helsinki, , 00029
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Local Institution - 0048
Tampere, , 33521
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Local Institution - 0138
Lille, , 59037
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Local Institution - 0135
Marseille Cedex 5, , 13385
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Local Institution - 0134
Nantes, , 44000
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Local Institution - 0136
Paris, , 75010
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Local Institution - 0133
Pierre Benite, , 69495
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Local Institution - 0137
Toulouse, , 31059
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Local Institution - 0086
Athens, , 11526
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Local Institution - 0087
Neo Faliro, , 18547
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Local Institution - 0163
Budapest, , 1122
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Local Institution - 0166
Dublin 7, , 0
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Local Institution - 0063
Dublin, , 01
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Local Institution - 0108
Dublin, , 4
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Local Institution - 0064
Galway, ,
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Local Institution - 0112
Bergamo, , 24127
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Local Institution - 0116
Genova, , 16128
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Local Institution - 0115
Meldola (FC), , 47014
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Local Institution - 0113
Milano, , 20133
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Local Institution - 0107
Napoli, , 80131
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Local Institution - 0111
Padova, , Padova
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Local Institution - 0114
Roma, , 00144
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Local Institution - 0110
Siena, , 53100
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Local Institution - 0179
Nagoya, Aichi, 466-8560
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Local Institution - 0161
Fukuoka-shi, Fukuoka, 8128582
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Local Institution - 0174
Tsukuba-shi, Ibaraki, 3058576
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Local Institution - 0162
Kumamoto-shi, Kumamoto, 8608556
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Local Institution - 0160
Matsumoto, Nagano, 3908621
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Local Institution - 0175
Niigata-shi, Niigata, 9518566
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Local Institution - 0176
Osaka-shi, Osaka, 5400006
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Local Institution - 0159
Sunto-gun, Shizuoka, 4118777
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Local Institution - 0158
Chuo-ku, Tokyo, 1040045
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Local Institution - 0180
Chuo-shi, Yamanashi, 4093898
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Local Institution - 0144
Songpa-gu, Seoul, 05505
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Local Institution - 0129
Seoul, , 03080
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Local Institution - 0127
Seoul, , 03722
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Local Institution - 0128
Seoul, , 06351
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Local Institution - 0042
Amsterdam, , 1081 HV
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Local Institution - 0045
Groningen, , 9714 CZ
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Local Institution - 0043
Nijmegen, , 6525GA
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Local Institution - 0041
Veldhoven, , 5504 DB
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Local Institution - 0098
Bergen, , 5021
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Local Institution - 0109
Oslo, , 3100
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Local Institution - 0150
Gdansk, , 80-219
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Local Institution - 0149
Krakow, , 31-115
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Local Institution - 0152
Warszawa, , 02-781
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Local Institution - 0156
Craiova, , 200542
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Local Institution - 0153
Romania, , 400015
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Local Institution - 0148
Johannesburg, Gauteng, 2196
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Local Institution - 0145
Pretoria, Gauteng, 0075
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Local Institution - 0147
Saxonwold, Johannesburg, Gauteng, 2196
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Local Institution - 0181
Cape Town, Western CAPE, 7700
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Local Institution - 0146
Kraaifontein, Western Cape, 7570
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Local Institution - 0120
Barcelona, , 08036
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Local Institution - 0119
Madrid, , 28007
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Local Institution - 0121
Sevilla, , 41009
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Local Institution - 0122
Valencia, , 46014
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Local Institution - 0050
Gothenberg, , 413 45
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Local Institution - 0096
Lund, , 221 85
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Local Institution - 0167
Zuerich, , 8091
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Local Institution - 0131
Kaohsiung, , 833
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Local Institution - 0132
Taichung, , 404
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Local Institution - 0130
Taoyuan, , 333
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Local Institution - 0057
Bristol, Avon, BS2 8ED
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Local Institution - 0052
Swansea, Carmarthenshire, SA2 8QA
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Local Institution - 0165
London, Greater London, SW3 6JJ
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Local Institution - 0054
Manchester, Greater Manchester, M20 4BX
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Local Institution - 0056
Southampton, Hampshire, SO16 6YD
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Local Institution - 0177
Northwood, Middlesex, HA6 2JR
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Local Institution - 0055
Oxford, Oxfordshire, OX3 7LJ
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Local Institution - 0060
Newcastle Upon Tyne, Tyne And Wear, NE7 7DN
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Local Institution - 0097
Leicester, , LE15WW
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Local Institution - 0053
Surrey, , SM2 5PT