Actively Recruiting
Integration of the PD-L1 Inhibitor Atezolizumab and WT1/DC Vaccination Into Platinum/Pemetrexed-based First-line Treatment for Epithelioid Malignant Pleural Mesothelioma
Led by University Hospital, Antwerp · Updated on 2024-05-16
15
Participants Needed
3
Research Sites
187 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Antwerp
Lead Sponsor
A
Algemeen Ziekenhuis Maria Middelares
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this multicenter phase I/II 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 platinum/pemetrexed-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 platinum/pemetrexed-based chemotherapy with atezolizumab and WT1/DC vaccination is feasible and safe, has clinical activity and enables the induction of mesothelioma-specific immune responses in patients with MPM.
CONDITIONS
Official Title
Integration of the PD-L1 Inhibitor Atezolizumab and WT1/DC Vaccination Into Platinum/Pemetrexed-based First-line Treatment for Epithelioid Malignant Pleural Mesothelioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Diagnosis of histologically proven epithelioid unresectable malignant pleural mesothelioma (stage I-IV)
- Age 18 years or older
- WHO performance status 0-1
- Adequate blood counts and organ function as defined by specific laboratory criteria
- Negative tests for HIV, hepatitis B, and hepatitis C
- Willingness and ability to comply with study procedures
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after treatment
- Men must agree to use effective contraception during and after treatment
You will not qualify if you...
- History of other malignancy within 3 years, except certain low-risk cancers
- Symptomatic, untreated, or progressing brain metastases
- History of leptomeningeal disease
- Active or history of autoimmune disease or immune deficiency with some exceptions
- History of specific lung diseases or active pneumonitis
- Significant cardiovascular disease within 3 months
- Major surgery within 4 weeks or planned during study
- Severe infection within 4 weeks prior to treatment
- Prior treatment for malignant pleural mesothelioma
- Recent therapeutic antibiotic treatment
- Prior allogeneic stem cell or organ transplant
- Use of investigational agents within 28 days
- Pregnancy or breastfeeding
- Recent live vaccine use
- Current antiviral therapy for hepatitis B
- Prior treatment with certain immune therapies
- Recent systemic immunosuppressive or immunostimulatory treatments with exceptions
- History of severe allergic reactions to similar antibodies
- Known hypersensitivity to components of atezolizumab
- Any other condition that may contraindicate study treatments or affect compliance
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
2
AZ Maria Middelares
Ghent, Belgium, 9000
Actively Recruiting
3
VITAZ
Sint-Niklaas, Belgium, 9100
Actively Recruiting
Research Team
Z
Zwi N Berneman, MD, PhD
CONTACT
B
Barbara Stein, MSc
CONTACT
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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