Pilot Study of Intrapleural Photodynamic Therapy via Video-Assisted Thoracoscopy Followed by Nivolumab Immunotherapy for Malignant Pleural Mesothelioma

What this Trial Is About

Researchers are evaluating a new combined treatment approach for patients with malignant pleural mesothelioma, a type of cancer affecting the lining of the lungs. This phase 2 pilot study explores the feasibility of using intrapleural photodynamic therapy with videothoracoscopy followed by immunotherapy with anti-PD-1 Nivolumab antibodies. The aim is to assess how well patients can complete this multimodal treatment and observe its effects over an average of 24 months. Patients first receive an oral photosensitizer called 5-Aminolevulinic Acid 5-ALA several hours before undergoing a thoracoscopy procedure. During this procedure, the pleural cavity is illuminated with a laser to activate the therapy. A device may be inserted to manage pleural fluid and assist in pleurodesis. After about a week, patients start intravenous Nivolumab treatment every two weeks for up to two years, with CT scans every eight cycles to monitor disease progression or side effects. During the study, participants will have regular assessments including imaging scans to measure tumor response, survival tracking, and questionnaires to evaluate quality of life and chest pain. Researchers will closely monitor treatment completion rates and safety over the 24-month period. This includes evaluating objective response rates, progression-free survival, overall survival, and patient well-being to better understand this treatment combinations feasibility and impact.

The IMmunotherapy Pleural 5-ALA PDT