PHASE III STUDY WITH ATEZOLIZUMAB VERSUS PLACEBO IN MALIGNANT PLEURAL MESOTHELIOMA PATIENTS AFTER PLEURECTOMY/DECORTICATIO

Phase 1

• Conditions: MALIGNANT PLEURAL MESOTHELIOMA PATIENTS; 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: EUCTR2020-003762-39-IT
• Lead Sponsor: GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 162

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified