Study identifier:D7988C00001
ClinicalTrials.gov identifier:NCT06097728
EudraCT identifier:2023-000067-32
CTIS identifier:2023-503231-17-00
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)
Unresectable Pleural mesothelioma
Phase 3
No
Volrustomig, Pemetrexed, Carboplatin, Cisplatin, Nivolumab, Ipilimumab
All
600
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Volrustomig + Carboplatin + pemetrexed Volrustomig in combination with carboplatin plus pemetrexed | Drug: Volrustomig MEDI5752: Administered as IV infusion Other Name: MEDI5752 Drug: Pemetrexed Alimta: Administered as IV infusion Other Name: Alimta Drug: Carboplatin Paraplatin: Administered as IV infusion Other Name: Paraplatin |
Active Comparator: Investigator's choice of standard care The investigator’s choice of nivolumab plus ipilimumab or platinum plus pemetrexed chemotherapy for participants with epithelioid histology, and nivolumab plus ipilumab for participants with non-epithelioid histology. | Drug: Pemetrexed Alimta: Administered as IV infusion Other Name: Alimta Drug: Carboplatin Paraplatin: Administered as IV infusion Other Name: Paraplatin Drug: Cisplatin Platinol: Administered as IV infusion Other Name: Platinol Drug: Nivolumab Opdivo: Administered as IV infusion Other Name: Opdivo Drug: Ipilimumab Yervoy: Administered as IV infusion Other Name: Yervoy |