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Active (not recruiting) Phase 3 NCT04099251

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

Phase 3 – large-scale trial before approval
Conditions: Melanoma

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
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.
Who can participate
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 Other protocol defined inclusion/exclusion criteria apply.
Locations 17
Australia (1)
Local Institution - 0018
Waratah , New South Wales
Belgium (1)
Local Institution - 0028
Charleroi
Canada (1)
Local Institution - 0134
Calgary , Alberta
Czech Republic (1)
Local Institution - 0074
Prague , Praha 2
Denmark (1)
Local Institution - 0007
Aarhus N
Finland (1)
Local Institution - 0014
Helsinki , Etelä-Suomen Lääni
France (1)
Local Institution - 0113
Brest , Finistère
Greece (1)
Local Institution - 0084
Athens , Attikí
Italy (1)
Local Institution - 0046
Palermo , Sicily
Netherlands (1)
Local Institution - 0107
Breda
Norway (1)
Local Institution - 0063
Bergen
Poland (1)
Local Institution - 0103
Poznan , Greater Poland Voivodeship
Romania (1)
Local Institution - 0047
Cluj-Napoca
Spain (1)
Local Institution - 0071
Barcelona , Barcelona [Barcelona]
Sweden (1)
Local Institution - 0026
Örebro
United Kingdom (1)
Local Institution - 0044
Cardiff
United States (1)
Local Institution - 0088
Birmingham , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Years
Healthy volunteers
No
Start date
28.10.2019
Completion date
29.06.2027
Registry ID
NCT04099251
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.