Integration of the PD-L1 Inhibitor Atezolizumab and WT1/DC Vaccination Into Platinum/Pemetrexed-b… (NCT05765084) | Clinical Trial Compass
RecruitingPhase 1/2
Integration of the PD-L1 Inhibitor Atezolizumab and WT1/DC Vaccination Into Platinum/Pemetrexed-based First-line Treatment for Epithelioid Malignant Pleural Mesothelioma
Belgium15 participantsStarted 2023-02-24
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Subjects must meet all the following criteria to be eligible to participate in the study:
* Signed informed consent
* Diagnosis with histologically proven epithelioid unresectable MPM (stage I-IV)
* Age ≥ 18 years at the time of signing informed consent
* World Health Organization (WHO) performance status 0-1
* Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained at the time of screening:
* Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (1500/μL) without granulocyte colony- stimulating factor support
* Lymphocyte count ≥ 0.5 x 10\^9/L (500/μL)
* Platelet count ≥ 100 x 10\^9/L (100,000/μL) without transfusion
* Hemoglobin ≥ 90 g/L (9 g/dL) Patients may be transfused to meet this criterion
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 x upper limit of normal (ULN), with the following exceptions:
* Patients with documented liver metastases: AST and ALT ≤ 5 x ULN
* Patients with documented liver or bone metastases: ALP ≤ 5 x ULN
* Total bilirubin ≤ 1.5 x ULN with the following exception:
* Patients with known Gilbert disease: total bilirubin ≤ 3 x ULN
* Creatinine ≤ 1.5 x ULN
* Albumin ≥ 25 g/L (2.5 g/dL)
* For patients not receiving therapeutic anticoagulation: prothrombin international normalized ration (PT-INR) and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN
* Negative Human Immunodeficiency Virus (HIV) test …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients that experienced (S)AEs possibly, probably or definitely related to pemetrexed and/or cisplatin/carboplatin and/or atezolizumab and/or WT1/DC vaccination
Timeframe: through study completion, an average of 2 years
2
Number and grade of AEs and SAEs
Timeframe: through study completion, an average of 2 years
3
Proportion of patients who completed study treatment schedule
Timeframe: After the chemoimmunotherapy treatment (+/- 18 weeks after entry to trial)