Groupe d'Etude en Oncologie du Quebec

Titre	A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma
Protocole ID	CA209-76K
ClinicalTrials.gov ID	NCT04099251
Type(s) de cancer	Mélanome
Phase	Phase III
Type étude	Traitement
Médicament	Nivolumab
Institution	CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE HOPITAL FLEURIMONT 3001 12e Avenue Nord, Sherbrooke, QC, J1H 5N4
Ville	Sherbrooke
Investigateur(trice) principal(e)	Dr Robert Hanel
Coordonnateur(trice)	Anick Champoux 819-346-1110 poste 12811
Statut	Fermé
Critètes d'éligibilité	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
Critètes d'exclusion	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 could apply.

Groupe d'étude en oncologie du Québec