NCT03007030

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

Phase II Trial of Adcetris (Brentuximab Vedotin) in CD30+ Malignant Mesothelioma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well brentuximab vedotin works in treating patients with CD30 positive (+) malignant mesothelioma that cannot be removed by surgery. Monoclonal antibodies, such as brentuximab vedotin, may interfere with the ability of tumor cells to grow and spread.

Detailed description

PRIMARY OBJECTIVES: I. To assess 4-month disease control rate (DCR) in pre-treated patients with unresectable malignant pleural mesothelioma (MPM) treated with brentuximab vedotin. SECONDARY OBJECTIVES: I. To evaluate the response rate, progression-free and overall survival, and safety/toxicity of brentuximab vedotin in CD30+ malignant mesothelioma. II. To prospectively evaluate the incidence of CD30+ expression in malignant mesothelioma during the screening process. III. To determine whether CD30+ expression levels in tumor tissue correlate to response to brentuximab vedotin. EXPLORATORY OBJECTIVES: I. To collect archival or new tissue and blood for correlative studies. II. Next generation sequencing (NGS) will be conducted on adequate tumor tissue specimens. III. Exploratory analysis: Bank peripheral blood at baseline for subsequent cytokine or reverse phase protein array (RPPA). OUTLINE: Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, 3 months, 6 months and then every 6 months thereafter.

Conditions

• CD30-Positive Neoplastic Cells Present
• Malignant Mesothelioma

Interventions

Type	Name	Description
DRUG	Brentuximab Vedotin	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2017-04-05
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2016-12-30
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study