Volrustomig with Carboplatin & Pemetrexed in mesothelioma patients
Research type
Research Study
Full title
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)
IRAS ID
1007541
Contact name
Yehan Wijesinghe
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2023-000067-32
Clinicaltrials.gov Identifier
Research summary
Researchers are looking for a better way to treat advanced pleural mesothelioma. Pleural mesothelioma is a type of cancer that affects the lining of the lungs. Advanced usually means that the cancer cannot be treated with surgery. The most common cause of pleural mesothelioma is being exposed to a toxic mineral called asbestos.
Life expectancy is low for people with advanced pleural mesothelioma, even with current standard treatments. Current standard treatments include nivolumab, ipilimumab, or chemotherapy. The trial drug, volrustomig, is designed to help the immune system kill cancer
cells. Researchers want to find out if the combination volrustomig with chemotherapy works better than standard treatments for participants with advanced pleural mesothelioma.This is a phase 3, randomized, open-label trial. Randomized means that the treatment each participant receives will be randomly assigned by a computer program. Open-label means the participants, researchers, trial doctors, and other trial staff will know what each participant is
receiving. Participants will receive treatment for up to 2 years or until their cancer gets worse.This trial will include about 600 participants with advanced pleural mesothelioma.
Participants will be randomly assigned to one of the 2 treatment groups:
-Experimental Arm: 4 to 6 cycles of Volrustomig + Carboplatin + Pemetrexed in Treatment period 1, followed by Volrustomig alone in Treatment period 2.-Control Arm (SoC): 4 to 6 cycles of Nivolumab + Ipilimumab or Pemetrexed + Platinum Chemo (Carboplatin or Cisplatin) in Treatment period 1, followed by Nivolumab + Ipilimumab in Treatment period 2.
All treatments will be given through a needle put into a vein (IV infusion).
The length of time a patient will receive the treatment will depend on their individual response to it. The maximum time a patient will receive a treatment is 2 years as per standard of care.REC name
London - Riverside Research Ethics Committee
REC reference
23/LO/0734
Date of REC Opinion
18 Oct 2023
REC opinion
Further Information Favourable Opinion