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
|