Titre A Phase 3 Randomized Study Comparing Nivolumab and Ipilimumab Combination vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse
Protocole ID CA209-914
ClinicalTrials.gov ID NCT03138512
Type(s) de cancer Rein
Phase Phase III
Stade Adjuvant
Type étude Traitement
Médicament nivolumab et ipilimumab
Institution CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL  
Ville Montréal
Investigateur(trice) principal(e) Dr Fred Saad
Coordonnateur(trice) Amal Nadiri
514-890-8000 poste 26074
Statut Actif en recrutement
Critètes d'éligibilité
  • 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
Critètes d'exclusion
  • 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