Gruppo Oncologico Italiano di Ricerca Clinica is recruiting patients for a PHASE3 clinical trial testing atezolizumab (Tecentriq) for mesothelioma.
The trial, designated NCT04996017, aims to enroll up to 162 participants at 19 sites.
About the Study
This is a multicentric double-blind, placebo controlled, phase III trial. In this study, patients who underwent to a surgical resection of pleural mesothelioma and are without signs of macroscopic residual disease will be randomized 2:1 to receive atezolizumab or placebo. Patients will be treated for 12 months or until recurrence, unacceptable toxicity or patient/physician decision, whichever occurs first.
Randomization will be done via a centralized system and patients will be stratified histology (epithelioid vs non epithelioid) and stage (I vs
>I). Patients will be radiologically evaluated after surgical procedure before starting therapy and then every 12 weeks for 24 months or until disease progression. At screening patients should be without macroscopic residual disease. Quality of life questionnaire will be administered to patient at baseline and every 12 weeks. During the study baseline tumor blocks will be centrally analyzed to determinate biological characteristics and gene expression.
Treatment Approach
This trial uses a PD-L1 checkpoint inhibitor being studied in combination with other treatments.
Key trial details:
- Phase: PHASE3
- Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica
- Enrollment target: 162
- Status: RECRUITING
Why This Trial Matters
Phase 3 trials are the final stage before FDA approval, making this study particularly significant for patients seeking access to new treatments.
Study Locations
Contact the trial sponsor for information about participating sites.
How to Enroll
Patients interested in this trial should:
- Discuss eligibility with their oncologist
- Review the full eligibility criteria on ClinicalTrials.gov
- Contact the study coordinator for screening