Groupe d'Etude en Oncologie du Quebec

Titre	A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors
Protocole ID	CA224-020
ClinicalTrials.gov ID	NCT01968109
Type(s) de cancer	Mélanome
Phase	Phase I-II
Institution	CHU DE QUEBEC – UNIVERSITE LAVAL L'HOTEL-DIEU DE QUEBEC ET CRCEO 11 Côte du Palais, Québec, QC, G1R 2J6
Ville	Québec
Investigateur(trice) principal(e)	Dr Joël Claveau
Coordonnateur(trice)	Mélanie Bradley 418-525-4444 poste 12950
Statut	Fermé
Critètes d'éligibilité	For Dose escalation: subjects with cervical, ovarian, bladder and colorectal cancer (CRC), head and neck, gastric and hepatocellular cancer naive to immuno-oncology agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or without anti-CTLA-4. For Dose Expansion: all of the above in escalation except for cervical, ovarian, and CRC Progressed, or been intolerant to, at least one standard treatment regimen, except for subjects in 1st line cohorts. ECOG performance status between 0 and 2 At least 1 lesion with measurable disease at baseline Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy)
Critètes d'exclusion	Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the only site of active disease Autoimmune disease Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent Uncontrolled CNS metastases

Groupe d'étude en oncologie du Québec