Informations générales (source: ClinicalTrials.gov)
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 (eVOLVE-Meso) (eVOLVE-Meso)
Interventional
Phase 3
AstraZeneca (Voir sur ClinicalTrials)
novembre 2023
mars 2028
25 avril 2025
This is a phase III, randomized, open-label, multicenter, global study to determine the
efficacy and safety of Volrustomig (MEDI5752) + Carboplatin + Pemetrexed vs the
investigator's choice of platinum + Pemetrexed or Nivolumab + Ipilimumab in participants
with unresectable pleural mesothelioma.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Research Site - 13015 - Marseille Cedex 20 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| Research Site - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Research Site - 34298 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Research Site - 44800 - Saint Herblain - France | Contact (sur clinicalTrials) | ||||
| Research Site - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| Research Site - 67091 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Research Site - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Research Site - 72037 - Le Mans Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 75877 - Paris - France | Contact (sur clinicalTrials) | ||||
| Research Site - 76031 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Research Site - 94010 - Creteil Cedex - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- 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
Key
- 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
Key
- 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