Trials / Recruiting
RecruitingNCT06097728
MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma
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)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 825 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
Adult patients with histologically proven diagnosis of pleural mesothelioma with advanced unresectable disease are eligible to be enrolled. Patients will be randomized 1:1 to receive Volrustomig (MEDI5752) + Carboplatin + Pemetrexed or the investigator's choice of platinum+Pemetrexed or Nivolumab+Ipilimumab, based on their histology.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Volrustomig | MEDI5752: Administered as IV infusion |
| DRUG | Pemetrexed | Alimta: Administered as IV infusion |
| DRUG | Carboplatin | Paraplatin: Administered as IV infusion |
| DRUG | Cisplatin | Platinol: Administered as IV infusion |
| DRUG | Nivolumab | Opdivo: Administered as IV infusion |
| DRUG | Ipilimumab | Yervoy: Administered as IV infusion |
Timeline
- Start date
- 2023-11-09
- Primary completion
- 2027-11-19
- Completion
- 2028-11-16
- First posted
- 2023-10-24
- Last updated
- 2026-04-02
Locations
178 sites across 21 countries: United States, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Italy, Japan, Netherlands, Norway, Poland, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06097728. Inclusion in this directory is not an endorsement.