Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05765084
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-02-13
Brief Title:
Integration of the PD-L1 Inhibitor Atezolizumab and WT1DC Vaccination Into PlatinumPemetrexed-based First-line Treatment for Epithelioid Malignant Pleural Mesothelioma
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
Integration of the PD-L1 Inhibitor Atezolizumab and WT1DC Vaccination Into PlatinumPemetrexed-based First-line Treatment for Epithelioid Malignant Pleural Mesothelioma
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Immuno-MESODEC
Brief Summary:
In this multicenter phase III trial the programmed death-ligand 1 PD-L1 inhibitor atezolizumab and dendritic cells DCs loaded with the mesothelioma-associated tumor antigen WT1 will be integrated into platinumpemetrexed-based first-line chemotherapy for the treatment of epitheloid malignant pleural mesothelioma MPM The general objective is to provide the first-in-human experimental demonstration that the combination of platinumpemetrexed-based chemotherapy with atezolizumab and WT1DC vaccination is feasible and safe has clinical activity and enables the induction of mesothelioma-specific immune responses in patients with MPM
Detailed Description:
Malignant pleural mesothelioma MPM is a highly aggressive and in virtually all cases fatal cancer that is tightly associated with prior asbestos exposure Despite some improvement over time the prognosis of patients diagnosed with MPM remains dismal with a median overall survival from diagnosis of only 9-16 months
In this single arm phase III trial the investigators want to demonstrate the feasibility and safety of integrating the programmed death-ligand 1 PD-L1 inhibitor atezolizumab and WT1-targeted dendritic cell vaccination in epitheloid MPM patients in conjunction with first line platinumpemetrexed-based chemotherapy In addition chemo-immunotherapy-induced immunogenicity will be studied and patients clinical outcome will be documented for comparison with current patients outcome allowing indication of the added value
Fifteen patients diagnosed with histologically proven epithelial MPM stage I-IV will be included Patients should be able to undergo leukapheresis chemotherapy and immunotherapy Patients who underwent prior treatment for MPM or with a history of another malignancy within the last three years will be excluded
The intention of this study is to administer four 3-weekly 3 days platinumpemetrexed-based chemotherapy cycles CT1-4 combined with atezolizumab treatments A1-4 and autologous WT1 messenger mRNA-loaded dendritic cells V1-4 at day 0 and day 14 3 days of each chemotherapy cycle respectively
Additional atezolizumab doses andor WT1DC vaccines after the chemo-immunotherapy study scheme can be administered to the patient if consent for continuation of atezolizumab treatment andor WT1DC vaccination was obtained and residual WT1DC vaccine aliquots are available In that case atezolizumab andor WT1DC vaccines will be administered on a 4-weekly basis 1 week The WT1DC vaccines will be administered within 1 week after atezolizumab administration
After the final WT1DC vaccination andor atezolizumab administration patients will enter a follow-up phase that lasts for up to 90 days after final WT1DC vaccination andor atezolizumab administration or 24 months after diagnosis whichever occurs later
In this single arm phase III trial the investigators want to demonstrate the feasibility and safety of integrating the programmed death-ligand 1 PD-L1 inhibitor atezolizumab and WT1-targeted dendritic cell vaccination in epitheloid MPM patients in conjunction with first line platinumpemetrexed-based chemotherapy In addition chemo-immunotherapy-induced immunogenicity will be studied and patients clinical outcome will be documented for comparison with current patients outcome allowing indication of the added value
Fifteen patients diagnosed with histologically proven epithelial MPM stage I-IV will be included Patients should be able to undergo leukapheresis chemotherapy and immunotherapy Patients who underwent prior treatment for MPM or with a history of another malignancy within the last three years will be excluded
The intention of this study is to administer four 3-weekly 3 days platinumpemetrexed-based chemotherapy cycles CT1-4 combined with atezolizumab treatments A1-4 and autologous WT1 messenger mRNA-loaded dendritic cells V1-4 at day 0 and day 14 3 days of each chemotherapy cycle respectively
Additional atezolizumab doses andor WT1DC vaccines after the chemo-immunotherapy study scheme can be administered to the patient if consent for continuation of atezolizumab treatment andor WT1DC vaccination was obtained and residual WT1DC vaccine aliquots are available In that case atezolizumab andor WT1DC vaccines will be administered on a 4-weekly basis 1 week The WT1DC vaccines will be administered within 1 week after atezolizumab administration
After the final WT1DC vaccination andor atezolizumab administration patients will enter a follow-up phase that lasts for up to 90 days after final WT1DC vaccination andor atezolizumab administration or 24 months after diagnosis whichever occurs later
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None