ATEZOLIZUMAB for Malignant pleural mesothelioma

Stratification factors

• Histology (epithelioid vs non epithelioid)
• Stage (I vs >I)

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years on day of signing informed consent\n- Histologically confirmed malignant pleural mesothelioma\n- Surgical resection (P/D), without macroscopic residual. In stage I patients without visceral involvement a total pleurectomy is allowed\n- Patients must have received at least 4 cycles of perioperative platinum/pemetrexed chemotherapy as per local practice. Less than 4 cycles of chemotherapy are allowed for clinical decisions - In patients previously treated with neoadjuvant chemotherapy, randomization should occur within 50 days from surgical resection. - In patients treated with adjuvant chemotherapy, randomization should occur within 30 ± 7 days from last dose of adjuvant treatment.\n- Performance status of 0-1 on the ECOG Performance Scale\n- Adequate organ function, all screening labs should be performed within 14 days of treatment initiation.\n- Availability of 1 tumor block at baseline."}

Exclusion criteria

• {"criterion_text":"- Patient with macroscopic residual disease after surgery\n- Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\n- Additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy\n- Active infection requiring systemic therapy\n- History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)\n- Active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected)\n- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab\n- Women with a positive pregnancy test at enrollment or prior to administration of study medication"}

Primary endpoints

• {"endpoint_text":"- DFS, defined as the time from initiation of study treatment to first recurrence of disease or death for any cause, whichever occurs first. DFS will be calculated based on disease status evaluated by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).","definition_or_measurement_approach":"DFS defined as the time from initiation of study treatment to first recurrence of disease or death for any cause; DFS will be calculated based on disease status evaluated by the investigator according to RECIST v1.1."}

Secondary endpoints

• {"endpoint_text":"- Incidence, nature, frequency, duration, timing and severity of serious adverse events (SAEs) and non-serious adverse events (AEs) related to atezolizumab treatment graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 5.","definition_or_measurement_approach":"AEs and SAEs related to atezolizumab graded by NCI CTCAE v5; incidence, nature, frequency, duration, timing and severity will be recorded."}
• {"endpoint_text":"- OS, defined as the time from start of study drug to the date of death from any cause.","definition_or_measurement_approach":"OS defined as time from start of study drug to date of death from any cause."}
• {"endpoint_text":"- EQ-5D-3L questionnaire","definition_or_measurement_approach":"Health-related quality of life measured by the EQ-5D-3L questionnaire."}

Italy

Earliest CTIS Part Ii Submission Date

31-10-2024

Latest Decision Or Authorization Date

22-01-2025

Processing Time Days

83

Number Of Sites

14

Number Of Participants

90

Primary sponsor

Full Name

G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica

Organisation Type

Patient organisation/association

Country Of Registered Address

Italy