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
Ville Québec
Investigateur(trice) principal(e) Dre Catherine Labbé
Coordonnateur(trice) Brigitte Fortin
 418-656-8711 poste 2639
Statut Actif en recrutement
Date d'activation 23-11-2023
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