MALIGNANT PLEURAL MESOTHELIOMA PATIENTS 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)
Conditions
Sponsors
GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years on day of signing informed consent • Histologically confirmed malignant pleural mesothelioma • Surgical resection (P/D), without macroscopic residual. In stage I patients without visceral involvement a total pleurectomy is allowed • 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. • Performance status of 0-1 on the ECOG Performance Scale • Adequate organ function, all screening labs should be performed within 14 days of treatment initiation. • Availability of 1 tumor block at baseline. 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 62
Exclusion criteria
Exclusion criteria: • Patient with macroscopic residual disease after surgery • 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 • 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 • Active infection requiring systemic therapy • History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) • Active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected) • 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 • Women with a positive pregnancy test at enrollment or prior to administration of study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the Disease Free Survival (DFS) defined as the time between the date of start of study drug and the first date of documented recurrence, based on investigator assessment as per RECIST 1.1 criteria, or death due to any cause, whichever occurs first.;Secondary Objective: Secondary End points To evaluate the safety of atezolizumab in terms of incidence, nature, frequency, duration, timing and severity of Adverse Events (AEs) and laboratory abnormalities graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 5. To evaluate the efficacy in terms of overall survival (OS) defined as the time from start of study drug to the date of death from any cause. To evaluate the quality of life of patients determinated with the EQ-5D questionnaire. Exploratory end points •To assess the role of biomarkers in the progression and fundamental biology of MPM •To evaluate biomarkers (e.g., cancer-related genes) as prognostic biomarkers;Primary end point(s): 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).;Timepoint(s) of evaluation of this end point: From initiation of study treatment to first recurrence of disease or death for any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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.; OS, defined as the time from start of study drug to the date of death from any cause.; EQ-5D-3L questionnaire; Sicurezza ed efficacia di atezolizumab in sottogruppi della popolazione in studio differenziati in base a: Espressione della proteina PD-L1 nel tessuto tumorale Presenza / assenza di altri biomarcatori nel tessuto tumorale Correlazioni tra l'espressione di PD-L1 e altri biomarcatori;Timepoint(s) of evaluation of this end point: each visit; death; screening, ogni ciclo (eccetto il ciclo 1), fine del trattamento; screening | — |
Countries
Italy
Contacts
Public ContactDipartimento ONCOLOGICO e TECNOLOGI
AUSL/IRCCS di Reggio Emilia
Outcome results
None listed