Atezolizumab for Epithelioid malignant pleural mesothelioma

Inclusion criteria

• {"criterion_text":"- Signed informed consent\n- Diagnosis with histologically proven epithelioid unresectable MPM (stage I-IV)\n- Aged ≥18 years at the time of signing the informed consent form\n- World Health Organization (WHO) performance status: grade 0-1\n- Adequate hematologic and end-organ function\n- Negative viral serology for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV)\n- Willing and able to comply with the study protocol, as judged by the treating physician\n- Women of childbearing potential must have a negative serum or urine pregnancy test at the time of screening"}

Exclusion criteria

• {"criterion_text":"- History of another malignancy within the last three years (except for malignancies with a negligible risk of metastasis or death)\n- Pregnant or breastfeeding\n- 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\n- Symptomatic, untreated, or actively progressing central nervous system metastases\n- Active or history of autoimmune disease or immune deficiency\n- Severe infection within 4 weeks prior to initiation of study treatment\n- Prior treatment for MPM\n- Prior allogeneic stem cell or solid organ transplantation\n- 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\n- Use of any investigational agent within 28 days before study enrollment\n- Recent treatment with systemic immunostimulatory agents or systemic immunosuppressive medication"}

Primary endpoints

• {"endpoint_text":"- Feasibility: the proportion of patients who completed study treatment schedule (i.e. administration of four platinum/pemetrexed-based chemotherapy cycles in combination with four atezolizumab treatments and four WT1/DC vaccinations","definition_or_measurement_approach":"Proportion of patients who completed the defined study treatment schedule (four platinum/pemetrexed cycles combined with four atezolizumab treatments and four WT1/DC vaccinations)."}
• {"endpoint_text":"- Safety, based on the occurrence of reported AEs and SAEs during investigational treatment administration and during follow-up: (A) 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 (B) Number and grade of AEs and SAEs","definition_or_measurement_approach":"Safety assessed by occurrence of reported adverse events (AEs) and serious adverse events (SAEs) during treatment and follow-up; includes proportions of patients experiencing (S)AEs possibly/probably/definitely related to study agents and the number and grade of AEs/SAEs."}

Secondary endpoints

• {"endpoint_text":"- Clinical efficacy, including: (A) Best overall response (BOR), duration of response (DOR), disease control rate (DCR), objective response rate (ORR) and progression free survival (PFS), (B) Overall survival (OS)","definition_or_measurement_approach":"Clinical efficacy assessed using endpoints including BOR, DOR, DCR, ORR, PFS and OS as listed in the protocol."}
• {"endpoint_text":"- Immunogenicity: Functional WT1-specific T cell responses","definition_or_measurement_approach":"Immunogenicity measured by assessment of functional WT1-specific T cell responses."}

Belgium

Earliest CTIS Part Ii Submission Date

27-08-2024

Latest Decision Or Authorization Date

22-01-2026

Processing Time Days

513

Number Of Sites

3

Number Of Participants

15

Primary sponsor

Full Name

Antwerp University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium