Integration of immunotherapy into first-line chemotherapy voor patients with epithelioid malignant pleural mesothelioma

Integration of the PD-L1 inhibitor atezolizumab and WT1/DC vaccination into platinum/pemetrexed-based first-line treatment for epithelioid malignant pleural mesothelioma - Immuno-MESODEC

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003229-31-BE

Enrollment

Registered

2022-08-25

Start date

2022-12-05

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant pleural mesothelioma, epithelioid subtype (stage I-IV) MedDRA version: 20.0 Level: LLT Classification code 10046859 Term: Vaccination System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: PT Classification code 10059518 Term: Pleural mesothelioma malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: cryopreserved Wilms' tumor 1 (WT1) mRNA-electroporated dendritic cells Product Code: WT1/DC Pharmaceutical Form: Suspension for injection INN or Proposed INN: WT1/DC Current Sponsor c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Signed informed consent - Diagnosis with histologically proven epithelioid unresectable MPM (stage I-IV) - Aged =18 years at the time of signing the informed consent form - World Health Organization (WHO) performance status: grade 0-1 - Adequate hematologic and end-organ function - Negative viral serology for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) - Willing and able to comply with the study protocol, as judged by the treating physician - Women of childbearing potential must have a negative serum or urine pregnancy test at the time of screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 3 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: - History of another malignancy within the last three years (except for malignancies with a negligible risk of metastasis or death) - Symptomatic, untreated, or actively progressing central nervous system metastases - Active or history of autoimmune disease or immune deficiency - Severe infection within 4 weeks prior to initiation of study treatment - Prior treatment for MPM - Prior allogeneic stem cell or solid organ transplantation - Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study - Use of any investigational agent within 28 days before study enrollment - Recent treatment with systemic immunostimulatory agents or systemic immunosuppressive medication - Pregnant or breastfeeding - Any other condition, either physical or psychological, or reasonable suspicion thereof on clinical or special investigation, which contraindicates the use of atezolizumab, pemetrexed, cisplatin/carboplatin and/or WT1/DC vaccines, or may negatively affect patient compliance, or may place the patient at higher risk of potential treatment complications.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the feasibility and safety of adding atezolizumab and WT1/DC vaccination to first-line platinum/pemetrexed-based chemotherapy in patients with epithelioid MPM.;Secondary Objective: - To assess indicators of clinical activity of first-line platinum/pemetrexed-based chemotherapy when combined with atezolizumab and WT1/DC vaccination in epithelioid MPM patients. - To determine the immunogenicity of atezolizumab and WT1/DC vaccination when added to first-line platinum/pemetrexed-based chemotherapy in epithelioid MPM patients. ;Primary end point(s): 1. Endpoint for feasibility is the proportion of patients who completed study treatment schedule (i.e. administration of four platinum/pemetrexed-based chemotherapy cycles (CT1-4) in combination with four atezolizumab treatments (A1-4) and four WT1/DC vaccinations (V1-4)). 2. Endpoint for safety of the combination of first-line platinum/pemetrexed-based chemotherapy with atezolizumab and WT1/DC vaccination is the occurrence of AEs and SAEs during investigational treatment administration and during follow-up, as reported according to to the latest version of the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) and Common Toxicity Criteria (CTC): - Proportions 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. - Number and grade of AEs and SAEs.;Timepoint(s) of evaluation of this end point: A first analysis will be done when 8 patients have survived 24 months after diagnosis. All available data for feasibility and safety will be evaluated. A second analysis will be done when all patients have reached an event (death) or 24 months after diagnosis. All available data for feasibility and safety will be reevaluated. At end of study (i.e. when all patients reached 90 days after final WT1/DC vaccination and/or atezolizumab administration or 24 months	—

Measure

Time frame

Main Objective: To investigate the feasibility and safety of adding atezolizumab and WT1/DC vaccination to first-line platinum/pemetrexed-based chemotherapy in patients with epithelioid MPM.;Secondary Objective: - To assess indicators of clinical activity of first-line platinum/pemetrexed-based chemotherapy when combined with atezolizumab and WT1/DC vaccination in epithelioid MPM patients. - To determine the immunogenicity of atezolizumab and WT1/DC vaccination when added to first-line platinum/pemetrexed-based chemotherapy in epithelioid MPM patients. ;Primary end point(s): 1. Endpoint for feasibility is the proportion of patients who completed study treatment schedule (i.e. administration of four platinum/pemetrexed-based chemotherapy cycles (CT1-4) in combination with four atezolizumab treatments (A1-4) and four WT1/DC vaccinations (V1-4)). 2. Endpoint for safety of the combination of first-line platinum/pemetrexed-based chemotherapy with atezolizumab and WT1/DC vaccination is the occurrence of AEs and SAEs during investigational treatment administration and during follow-up, as reported according to to the latest version of the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) and Common Toxicity Criteria (CTC): - Proportions 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. - Number and grade of AEs and SAEs.;Timepoint(s) of evaluation of this end point: A first analysis will be done when 8 patients have survived 24 months after diagnosis. All available data for feasibility and safety will be evaluated. A second analysis will be done when all patients have reached an event (death) or 24 months after diagnosis. All available data for feasibility and safety will be reevaluated. At end of study (i.e. when all patients reached 90 days after final WT1/DC vaccination and/or atezolizumab administration or 24 months

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Secondary

Measure	Time frame
Secondary end point(s): 1. Endpoints for clinical efficacy include: - Best overall response (BOR), duration of response (DOR), disease control rate (DCR), objective response rate (ORR) and progression free survival (PFS) of first-line platinum/pemetrexed-based chemotherapy in combination with atezolizumab and WT1/DC vaccination, as assessed according to the latest modified Response Evaluation Criteria In Solid Tumors (mRECIST) for malignant pleural mesothelioma and RECIST 1.1 criteria for metastatic lesions. - Overall survival (OS) from diagnosis and start of first-line treatment. 2. Endpoints for immunogenicity: - Functional WT1-specific T cell responses ;Timepoint(s) of evaluation of this end point: A first analysis will be done when 8 patients have survived 24 months after diagnosis. All available data for indicators of clinical efficacy and immunogenicity will be evaluated. A second analysis will be done when all patients have reached an event (death) or 24 months after diagnosis. All available data for indicators of clinical efficacy and immunogenicity will be reevaluated. At end of study (i.e. when all patients reached 90 days after final WT1/DC vaccination and/or atezolizumab administration or 24 months after diagnosis, whichever occurs later), final analysis for indicators of clinical efficacy and immunogenicity will be done. If the time between the second and final analysis is less than 12 months, only final analysis will be performed.	—

Measure

Time frame

Secondary end point(s): 1. Endpoints for clinical efficacy include: - Best overall response (BOR), duration of response (DOR), disease control rate (DCR), objective response rate (ORR) and progression free survival (PFS) of first-line platinum/pemetrexed-based chemotherapy in combination with atezolizumab and WT1/DC vaccination, as assessed according to the latest modified Response Evaluation Criteria In Solid Tumors (mRECIST) for malignant pleural mesothelioma and RECIST 1.1 criteria for metastatic lesions. - Overall survival (OS) from diagnosis and start of first-line treatment. 2. Endpoints for immunogenicity: - Functional WT1-specific T cell responses ;Timepoint(s) of evaluation of this end point: A first analysis will be done when 8 patients have survived 24 months after diagnosis. All available data for indicators of clinical efficacy and immunogenicity will be evaluated. A second analysis will be done when all patients have reached an event (death) or 24 months after diagnosis. All available data for indicators of clinical efficacy and immunogenicity will be reevaluated. At end of study (i.e. when all patients reached 90 days after final WT1/DC vaccination and/or atezolizumab administration or 24 months after diagnosis, whichever occurs later), final analysis for indicators of clinical efficacy and immunogenicity will be done. If the time between the second and final analysis is less than 12 months, only final analysis will be performed.

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Countries

Belgium

Contacts

Public ContactCCRG

Antwerp University Hospital

ccrg@uza.be003238213928

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026