Groupe d'Etude en Oncologie du Quebec

Titre	A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination With Ipilimumab or Nivolumab Monotherapy in Participants With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)
Protocole ID	CA209-848
ClinicalTrials.gov ID	NCT03668119
Type(s) de cancer	Tumeurs solides
Phase	Phase II
Stade	Maladie avancée ou métastatique
Type étude	Traitement
Médicament	Nivolumab avec Ipilimumab ou Nivolumab en monothérapie
Institution	CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
Ville	Montréal
Investigateur(trice) principal(e)	Dre Rahima Jamal
Coordonnateur(trice)	Francine Richard 514-890-8000 poste 24853
Statut	Fermé
Critètes d'éligibilité	Refractory, metastatic, or unresectable TMB-H solid tumors who must have received at least one prior line of therapy including standard of care, if available Available tumor tissue and blood for TMB testing Participants must have measurable disease for response assessment
Critètes d'exclusion	Participants with melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) or hematological malignancy as primary site of disease Participants who received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment

Groupe d'étude en oncologie du Québec