NCT03786419

A Study of Atezolizumab in Unresectable or Advaced Malignant Pleural Mesothelioma

Phase II Study to Evaluate the Efficacy and Safety of Atezolizumab in Subjects With Unresectable or Advanced Malignant Pleural Mesothelioma Who Experienced Progression on Platinum-Based Chemotherapy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Health Pharma Professional Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a national, single arm, phase II trial in patients with diagnosis of unresectable or advanced malignant pleural mesothelioma who experienced progression after platinum-based chemotherapy.

Detailed description

The study includes a screening period a treatment period, a termination treatment visit ≤30 days following the last dose of the study drug, and a follow-up period. Day 1 is defined as the first day in which patients receive atezolizumab. The study is expected to enroll 36 patients. Enrolled patients will receive a fixed dose of atezolizumab 1200 mg administered intravenously the first day of each cycle. A treatment cycle will last 21 days (± 3 days). Treatment with atezolizumab will continue until investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first). Treatment with atezolizumab may continue while patients experience clinical benefit based on the investigator's assessment (absence of unacceptable toxicity or symptomatic deterioration attributable to disease progression, at the discretion of the investigator after evaluating radiographic data, biopsy results \[if available\], and clinical status), or until unacceptable toxicity or death. During treatment, patients treated with atezolizumab, who demonstrate evidence of clinical benefit may continue treatment with atezolizumab after meeting disease progression criteria, based on the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The following need to be met, as specified by the protocol. All patients must undergo tumor assessments at baseline and every 9 weeks (± 7 days) following cycle 1, day 1, regardless of treatment delays, until radiographic disease progression, as per RECIST v1.1 modified for mesothelioma, or loss of clinical benefit in patients treated with atezolizumab, who continue treatment beyond disease progression, as per RECIST v1.1, withdrawal of consent, death or study termination by principal investigator, whichever occurs first. The study will end if all enrolled patients die, withdraw their consent, become lost to follow-up, or have been monitored during 12 months from the enrollment of the last patient, whichever occurs first.

Conditions

• Malignant Pleural Mesothelioma, Advanced
• Malignant Pleural Mesothelioma, Unresectable

Interventions

Type	Name	Description
DRUG	Atezolizumab	Participants will be given 1200 mg of Atezolizumab as single agent by IV infusion every 21 days. First infusion will be over 60 min. Subsequent Atezolizumab cycles may be administered for 30 minutes, if there were no perfusion-related toxicity

Timeline

• Start date: 2020-08-01
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2018-12-26
• Last updated: 2021-05-13

Locations

1 site across 1 country: Mexico