Groupe d'Etude en Oncologie du Quebec

Titre	A Phase Ib, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Atezolizumab in Patients With NRAS-Mutant Advanced Melanoma Who Have Received Anti-PD-1/PD-L1 Therapy
Protocole ID	GO42273
ClinicalTrials.gov ID	NCT04835805
Type(s) de cancer	Mélanome
Phase	Phase I
Type étude	Clinique
Médicament	Belvarafenib seul et en combinaison avec cobimetinib ou cobimetinib plus atézolizumab
Institution	CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS 3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
Ville	Montréal
Investigateur(trice) principal(e)	Dr Wilson Miller
Coordonnateur(trice)	Daria Krutauz 514-340-8222 poste 24301
Statut	Actif en recrutement
Critètes d'éligibilité	ECOG Performance Status of 0 or 1 Histologically confirmed, metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage III) cutaneous melanoma, that has progressed on or after treatment with anti-PD-1 or anti-PD-L1 therapy. Patients may have received up to two lines of systemic cancer therapy. Treatment with anti-PD-1/PD-L1 in the adjuvant setting is acceptable. Patients must have progressive disease at study entry Documentation of NRAS mutation-positive within 5 years prior to screening Tumor specimen availability Adequate hematologic and end-organ function Measurable disease per RECIST v1.1
Critètes d'exclusion	Treatment with systemic immunotherapy agents (e.g., anti-CTLA4, anti-PD(L)1, cytokine therapy, investigational therapy, etc.) within 28 days prior to C1D1 Symptomatic, untreated, or actively progressing CNS metastases History or signs/symptoms of clinically significant cardiovascular disease Known clinically significant liver disease History of autoimmune disease or immune deficiency Prior treatment with a MEK inhibitor (cobimetinib arm) History of or evidence of retinal pathology on ophthalmologic examination (cobimetinib arm) History of immune-related AE attributed to prior anti-PD(L)1 therapy that resulted in permanent discontinuation of anti-PD(L)1 therapy (atezolizumab arm)

Groupe d'étude en oncologie du Québec