Phase 2 Study of Brentuximab Vedotin for Treating CD30 Positive Malignant Mesothelioma That Cannot Be Removed by Surgery

What this Trial Is About

Researchers are evaluating how well brentuximab vedotin works in treating patients with CD30 positive malignant mesothelioma that cannot be removed by surgery. This phase II trial focuses on patients with unresectable malignant pleural mesothelioma who have been previously treated. The study aims to assess disease control rate, response rate, survival outcomes, safety, and to explore the relationship between CD30 expression and treatment response. Additional exploratory analyses include tissue and blood sample studies using advanced genetic sequencing and protein analysis techniques. Participants receive brentuximab vedotin through an intravenous infusion over 30 minutes on day 1 of each treatment cycle. These cycles repeat every 21 days unless the disease progresses or unacceptable side effects occur. The study also includes correlative laboratory biomarker analysis. After completing treatment, patients are followed up at 30 days, 3 months, 6 months, and then every 6 months for ongoing monitoring. During the trial, participants will undergo regular assessments to evaluate tumor response using standard criteria, along with monitoring overall survival, progression, and safety. Tissue and blood samples will be collected for biomarker studies. Follow-up visits continue up to five years to track long-term outcomes. The primary measure is disease control rate at four months, with secondary measures including tumor characteristics and CD30 expression levels.

Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery