Study of Atezolizumab and WT1DC Vaccine with PlatinumPemetrexed Chemotherapy for Treating Epithelioid Malignant Pleural Mesothelioma
Led by University Hospital, Antwerp · Updated on 2026-06-05
15
Participants Needed
3
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of atezolizumab, a PD-L1 inhibitor, and a WT1-targeted dendritic cell vaccine with standard platinumpemetrexed chemotherapy as a first-line treatment for patients with epithelioid malignant pleural mesothelioma MPM. This aggressive cancer, often linked to asbestos exposure, has a poor prognosis with median survival of 9-16 months. The trial aims to show that this new chemo-immunotherapy approach is safe, feasible, and can trigger immune responses against mesothelioma.
Participants will receive four cycles of chemotherapy every three weeks, each combined with atezolizumab infusions on day 0 and WT1DC vaccines on days 0 and 14 of each cycle. After completing this treatment phase, optional additional doses of atezolizumab and WT1DC vaccines may be given every four weeks if the patient agrees and vaccine supply permits. Following treatment, patients enter a follow-up period lasting up to 90 days after the last vaccine or atezolizumab dose or up to 24 months after diagnosis, whichever is longer.
During the study, patients will undergo regular assessments for safety, including monitoring of adverse events possibly related to the treatments, and evaluation of treatment completion. Researchers will also measure clinical responses such as tumor control and survival over an average of two years. Immune responses specific to WT1 will be assessed after the fourth vaccine and at later timepoints if disease control is sustained. The study involves a total participation duration covering treatment and extended follow-up for safety and effectiveness.
CONDITIONS
Brief Title
Integration of the PD-L1 Inhibitor Atezolizumab and WT1/DC Vaccination Into Platinum/Pemetrexed-based First-line Treatment for Epithelioid Malignant Pleural Mesothelioma
Research Team
Z
Zwi N Berneman, MD, PhD
B
Barbara Stein, MSc
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World Health Organization performance status of 0 or 1
Adequate blood counts and organ function per laboratory criteria at screening
Negative tests for HIV, hepatitis B, and hepatitis C as specified
Willingness and ability to follow study protocol
Women of childbearing potential must have a negative pregnancy test and use effective contraception during and after treatment; men must also use effective contraception
You will not qualify if you...
History of another malignancy within 3 years, except for low-risk cancers as specified
Symptomatic or untreated central nervous system metastases; some treated brain metastases allowed under strict conditions
History of leptomeningeal disease
Active or history of autoimmune diseases or immune deficiencies, with certain controlled exceptions
History or evidence of pneumonitis or lung-related conditions as specified
Significant cardiovascular disease within 3 months
Major surgery within 4 weeks prior to treatment or planned during study
Severe infection within 4 weeks prior to treatment
Prior treatment for malignant pleural mesothelioma
Recent therapeutic antibiotic treatment within 2 weeks
Prior allogeneic stem cell or solid organ transplant
Use of investigational agents within 28 days prior to enrollment
Pregnant or breastfeeding women
Recent live attenuated vaccine use or planned use during study
Current antiviral therapy for hepatitis B
Prior treatment with immune checkpoint inhibitors or CD137 agonists
Recent systemic immunosuppressive or immunostimulatory medications, with limited exceptions
History of severe allergic reactions to study drug components
Any other condition that contraindicates study treatments or may impact compliance or safety
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 12 weeks for four treatment cycles, with optional additional treatments on a 4-weekly basis
Participants receive four 3-weekly cycles of platinum/pemetrexed-based chemotherapy combined with atezolizumab infusions and WT1/DC vaccinations. Atezolizumab is administered on day 0 of each cycle, followed by chemotherapy, and WT1/DC vaccines are given on day 14 of each cycle. Additional optional atezolizumab and WT1/DC vaccinations may be administered every 4 weeks after the initial treatment schedule.
4 main treatment cycles with visits on day 0 and day 14 of each cycle, plus optional 4-weekly visits for additional treatments
Follow-up
Duration - Up to 90 days after last treatment or up to 24 months after diagnosis, whichever is later
After the final WT1/DC vaccination and/or atezolizumab administration, participants enter a follow-up phase lasting up to 90 days or 24 months after diagnosis, whichever is later, to monitor safety and clinical outcomes.
Visits scheduled as needed during follow-up
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Active specific immunotherapy targeting the Wilms' tumor protein 1 (WT1) for patients with hematological malignancies and solid tumors: lessons from early clinical trials.
Ann Van Driessche, Zwi N Berneman, Viggo F I Van Tendeloo
Highly efficient gene delivery by mRNA electroporation in human hematopoietic cells: superiority to lipofection and passive pulsing of mRNA and to electroporation of plasmid cDNA for tumor antigen loading of dendritic cells.
Integration of the PD-L1 inhibitor atezolizumab and WT1/DC vaccination into standard-of-care first-line treatment for patients with epithelioid malignant pleural mesothelioma-Protocol of the Immuno-MESODEC study.
Jolien Van den Bossche, Maxime De Laere, Koen Deschepper...