Rein

TITRE	Étude de phase III à répartition aléatoire comparant l’association nivolumab et ipilimumab à un placebo chez des participants atteints d’un adénocarcinome rénal localisé ayant subi une néphrectomie radicale ou partielle et qui présentent un risque élevé de récidive de la maladie
PROTOCOLE ID	CA209-914
CLINICAL TRIAL.gov ID	NCT03138512
TYPE(S) DE CANCER	Rein
PHASE	Phase III
TYPE D'ÉTUDE	Traitement
INSTITUTION	CISSS DU BAS-SAINT-LAURENT 288 Rue Pierre-Saindon (418) 724-5231
VILLE	Rimouski
INVESTIGATEUR(RICE) PRINCIPAL(E)	Gabrielle Gagnon
COORDONATEUR(RICE)	Isabelle Gagnon isabelle.gagnon0109.cisssbsl@ssss.gouv.qc.ca 418-724-3000 poste 8029
STATUT	Fermé
CRITÈRES D'ÉLIGIBILITÉ	(EN) Kidney tumor has been completely resected 4 to 12 weeks prior to randomization Pathologic TNM staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0 Post-nephrectomy tumor shows RCC with a predominantly clear cell histology, including participants with sarcomatoid features
CRITÈRES D'EXCLUSION	(EN) Participants with an active known or suspected autoimmune disease Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation Participants with a condition requiring systemic treatment with corticosteroids