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

Phase 1

Conditions: Malignant pleural mesothelioma, epithelioid subtype (stage I-IV)
MedDRA version: 20.0Level: LLTClassification code 10046859Term: VaccinationSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 20.0Level: PTClassification code 10059518Term: Pleural mesothelioma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2021-003229-31-BE

Lead Sponsor: Antwerp University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 15

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

- 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.