NCT02959463

Pembrolizumab After Radiation Therapy in Treating Patients With Pleural Malignant Mesothelioma

Phase I Trial of Adjuvant Pembrolizumab After Radiation Therapy for Lung-Intact Malignant Pleural Mesothelioma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best way to give pembrolizumab after radiation therapy in treating patients with pleural malignant mesothelioma. Radiation therapy uses high energy radiation to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab after radiation therapy may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety and tolerability of pembrolizumab administered after radiation therapy in patients with malignant pleural mesothelioma (MPM) who have not undergone extrapleural pneumonectomy. SECONDARY OBJECTIVES: I. To assess progression-free and overall survival (progression free survival \[PFS\] and overall survival \[OS\], respectively) in patients receiving pembrolizumab after radiation therapy for malignant pleural mesothelioma (MPM). EXPLORATORY OBJECTIVES: I. To evaluate biomarkers of interest, including cytokines, measurements of T-cell activation, and serum exosome micro ribonucleic acid (RNA)s with the delivery of pembrolizumab after radiation therapy for MPM. OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT 1: Patients undergo hemithoracic radiation therapy. COHORT 2: Patients undergo palliative radiation therapy over 1-3 weeks to only the region of palliation (a region that does not include the entire side of the chest or thorax). After radiation therapy, both cohorts receive pembrolizumab intravenously (IV) over about 30 minutes on day 1. Courses repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, every 6 weeks for 48 weeks, then every 12 weeks for up to 5 years.

Conditions

• Pleural Malignant Mesothelioma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
RADIATION	Palliative Radiation Therapy	Undergo palliative radiation therapy
BIOLOGICAL	Pembrolizumab	Given IV
RADIATION	Radiation Therapy	Undergo hemithoracic radiation therapy

Timeline

• Start date: 2017-05-01
• Primary completion: 2024-11-15
• Completion: 2028-12-31
• First posted: 2016-11-09
• Last updated: 2026-03-06
• Results posted: 2025-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study