Groupe d'Etude en Oncologie du Quebec

Titre	A Phase III, Randomized, Open-Label, Multicenter, Global Study of Volrustomig (MEDI5752) in Combination With Carboplatin Plus Pemetrexed Versus Platinum Plus Pemetrexed or Nivolumab Plus Ipilimumab in Participants With Unresectable Pleural Mesothelioma
Protocole ID	eVOLVE-Meso
ClinicalTrials.gov ID	NCT06097728
Type(s) de cancer	Mésothéliome
Phase	Phase III
Type étude	Clinique
Médicament	Volrustomig + carboplatine + pemetrexed versus un platine + pemetrexed ou nivolumab + ipilimumab
Institution	CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
Ville	Montréal
Investigateur(trice) principal(e)	Dre Marie Florescu
Coordonnateur(trice)	Chantal Gosselin 514-890-8000 poste 24892
Statut	Actif en recrutement
Date d'activation	12-12-2023
Critètes d'éligibilité	Participant must be ≥ 18 years at the time of screening Histologically proven diagnosis of pleural mesothelioma with known histology (epithelioid vs. non-epithelioid) Advanced unresectable disease that cannot be treated with curative surgery (with or without chemotherapy) WHO/ECOG performance status of 0 or 1 with no deterioration (that is, ECOG PS>1) over the previous 2 weeks prior to day of first dosing Has measurable disease per modified RECIST1.1 Has adequate bone marrow reserve and organ function at baseline
Critètes d'exclusion	As judged by the investigator, any condition that would interfere with evaluation of the investigational product or interpretation of participant safety or study results. Active or prior documented autoimmune or inflammatory disorders History of another primary malignancy with exceptions. Uncontrolled intercurrent illness Tuberculosis, hepatitis B (HBV) or hepatitis C (HCV), human immunodeficiency virus (HIV) infection that is not well controlled Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment Untreated or progressive CNS metastatic disease

Groupe d'étude en oncologie du Québec