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NCT04099251Active, not recruitingPhase 3

Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma

A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma

Source: ClinicalTrials.gov · Last updated 7 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
790 (actual)
First submitted
20 Sept 2019
Start date
28 Oct 2019
Primary completion date
28 Jun 2022
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT04099251
EudraCT number
2022-502354-14

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 790
  • From 28 Oct 2019 to the primary completion date, 28 Jun 2022
  • 130 sites in 20 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
    • Other protocol defined inclusion/exclusion criteria apply.

Other illness

  • History of ocular or mucosal melanoma.
  • Participants with active known or suspected autoimmune disease.
  • Known history of allergy or hypersensitivity to study drug components.

Other

  • Pregnant or nursing women.

Who the study is looking for

  • 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.

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (130)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Local Institution - 0049
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GrazAustriaUnknown status
Local Institution - 0051
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InnsbruckAustriaUnknown status
Local Institution - 0050
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SalzburgAustriaUnknown status
Local Institution - 0048
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ViennaAustriaUnknown status
Local Institution - 0019
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Box HillAustraliaUnknown status
Local Institution - 0105
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CairnsAustraliaUnknown status
Local Institution - 0125
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GeelongAustraliaUnknown status
Local Institution - 0017
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GreenslopesAustraliaUnknown status
Local Institution - 0024
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HerstonAustraliaUnknown status
Local Institution - 0128
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MalvernAustraliaUnknown status
Local Institution - 0106
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MelbourneAustraliaUnknown status
Local Institution - 0104
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NedlandsAustraliaUnknown status
Local Institution - 0138
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SouthportAustraliaUnknown status
Local Institution - 0018
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WaratahAustraliaUnknown status
Local Institution - 0025
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WestmeadAustraliaUnknown status
Local Institution - 0016
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WollstonecraftAustraliaUnknown status
Local Institution - 0028
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CharleroiBelgiumUnknown status
Local Institution - 0011
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GhentBelgiumUnknown status
Local Institution - 0008
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KortrijkBelgiumUnknown status
Local Institution - 0010
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LiègeBelgiumUnknown status
Local Institution - 0134
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CalgaryCanadaUnknown status
Local Institution - 0131
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HalifaxCanadaUnknown status
Local Institution - 0142
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HamiltonCanadaUnknown status
Local Institution - 0124
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KingstonCanadaUnknown status
Local Institution - 0116
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MontrealCanadaUnknown status
Local Institution - 0123
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SherbrookeCanadaUnknown status
Local Institution - 0140
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TorontoCanadaUnknown status
Local Institution - 0133
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VancouverCanadaUnknown status
Local Institution - 0053
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LausanneSwitzerlandUnknown status
Local Institution - 0052
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ZurichSwitzerlandUnknown status
Local Institution - 0075
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Ostrava-PorubaCzechiaUnknown status
Local Institution - 0073
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PragueCzechiaUnknown status
Local Institution - 0074
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PragueCzechiaUnknown status
Local Institution - 0072
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BonnGermanyUnknown status
Local Institution - 0061
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BuxtehudeGermanyUnknown status
Local Institution - 0098
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DresdenGermanyUnknown status
Local Institution - 0054
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EssenGermanyUnknown status
Local Institution - 0062
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GeraGermanyUnknown status
Local Institution - 0114
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GöttingenGermanyUnknown status
Local Institution - 0060
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HanoverGermanyUnknown status
Local Institution - 0055
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HeidelbergGermanyUnknown status
Local Institution - 0057
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LübeckGermanyUnknown status
Local Institution - 0100
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MainzGermanyUnknown status
Local Institution - 0056
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MünchenGermanyUnknown status
Local Institution - 0102
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RegensburgGermanyUnknown status
Local Institution - 0058
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TübingenGermanyUnknown status
Local Institution - 0007
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Aarhus NDenmarkUnknown status
Local Institution - 0012
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HerlevDenmarkUnknown status
Local Institution - 0013
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OdenseDenmarkUnknown status
Local Institution - 0067
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A CoruñaSpainUnknown status
Local Institution - 0065
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BadalonaSpainUnknown status
Local Institution - 0071
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BarcelonaSpainUnknown status
Local Institution - 0070
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MadridSpainUnknown status
Local Institution - 0066
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MadridSpainUnknown status
Local Institution - 0068
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MálagaSpainUnknown status
Local Institution - 0064
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SantanderSpainUnknown status
Local Institution - 0069
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ValenciaSpainUnknown status
Local Institution - 0014
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HelsinkiFinlandUnknown status
Local Institution - 0015
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TampereFinlandUnknown status
Local Institution - 0110
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TurkuFinlandUnknown status
Local Institution - 0129
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BesançonFranceUnknown status
Local Institution - 0112
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BordeauxFranceUnknown status
Local Institution - 0113
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BrestFranceUnknown status
Local Institution - 0111
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LilleFranceUnknown status
Local Institution - 0033
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MarseilleFranceUnknown status
Local Institution - 0035
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NantesFranceUnknown status
Local Institution - 0130
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NiceFranceUnknown status
Local Institution - 0036
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ParisFranceUnknown status
Local Institution - 0032
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Pierre-BéniteFranceUnknown status
Local Institution - 0034
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VillejuifFranceUnknown status
Local Institution - 0044
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CardiffUnited KingdomUnknown status
Local Institution - 0095
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SouthamptonUnited KingdomUnknown status
Local Institution - 0082
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AthensGreeceUnknown status
Local Institution - 0084
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AthensGreeceUnknown status
Local Institution - 0083
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ThessalonikiGreeceUnknown status
Local Institution - 0040
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BergamoItalyUnknown status
Local Institution - 0146
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MilanItalyUnknown status
Local Institution - 0037
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MilanItalyUnknown status
Local Institution - 0101
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NaplesItalyUnknown status
Local Institution - 0039
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PadovaItalyUnknown status
Local Institution - 0046
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PalermoItalyUnknown status
Local Institution - 0145
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PerugiaItalyUnknown status
Local Institution - 0038
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SienaItalyUnknown status
Local Institution - 0107
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BredaNetherlandsUnknown status
Local Institution - 0001
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GroningenNetherlandsUnknown status
Local Institution - 0030
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RotterdamNetherlandsUnknown status
Local Institution - 0002
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UtrechtNetherlandsUnknown status
Local Institution - 0063
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BergenNorwayUnknown status
Local Institution - 0027
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GrålumNorwayUnknown status
Local Institution - 0005
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OsloNorwayUnknown status
Local Institution - 0023
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GdanskPolandUnknown status
Local Institution - 0103
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PoznanPolandUnknown status
Local Institution - 0022
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WarsawPolandUnknown status
Local Institution - 0047
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Cluj-NapocaRomaniaUnknown status
Local Institution - 0020
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CraiovaRomaniaUnknown status
Local Institution - 0021
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Sector 2RomaniaUnknown status
Local Institution - 0003
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LinköpingSwedenUnknown status
Local Institution - 0026
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ÖrebroSwedenUnknown status
Local Institution - 0092
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AllentownUnited StatesUnknown status
Local Institution - 0141
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AtlantaUnited StatesUnknown status
Local Institution - 0091
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AuroraUnited StatesUnknown status
Local Institution - 0144
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AustinUnited StatesUnknown status
Local Institution - 0135
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BaltimoreUnited StatesUnknown status
Local Institution - 0088
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BirminghamUnited StatesUnknown status
Local Institution - 0078
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BostonUnited StatesUnknown status
Local Institution - 0143
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BostonUnited StatesUnknown status
Local Institution - 0127
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BostonUnited StatesUnknown status
Local Institution - 0086
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CharlotteUnited StatesUnknown status
Local Institution - 0132
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ChicagoUnited StatesUnknown status
Local Institution - 0099
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ClevelandUnited StatesUnknown status
Local Institution - 0085
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DallasUnited StatesUnknown status
Local Institution - 0090
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FairfaxUnited StatesUnknown status
Local Institution - 0148
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GermantownUnited StatesUnknown status
Local Institution - 0093
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HackensackUnited StatesUnknown status
Local Institution - 0080
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Los AngelesUnited StatesUnknown status
Local Institution - 0151
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MinneapolisUnited StatesUnknown status
Local Institution - 0094
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New YorkUnited StatesUnknown status
Local Institution - 0079
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OmahaUnited StatesUnknown status
Local Institution - 0031
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PittsburghUnited StatesUnknown status
Local Institution - 0076
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PortlandUnited StatesUnknown status
Local Institution - 0081
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RobbinsdaleUnited StatesUnknown status
Local Institution - 0077
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San FranciscoUnited StatesUnknown status
Local Institution - 0119
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San FranciscoUnited StatesUnknown status
Local Institution - 0122
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San JoseUnited StatesUnknown status
Local Institution - 0087
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SpringdaleUnited StatesUnknown status
Local Institution - 0126
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TucsonUnited StatesUnknown status
Local Institution - 0109
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VallejoUnited StatesUnknown status
Local Institution - 0121
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VallejoUnited StatesUnknown status
Local Institution - 0120
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VallejoUnited StatesUnknown status
Local Institution - 0089
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Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.