RecruitingPhase 2NCT04400539

The IMmunotherapy Pleural 5-ALA PDT

Intrapleural Photodynamic Therapy by Video-Assisted Thoracoscopy Followed by Anti-PD-1 NIVOLUMAB in Patients With Malignant Pleural Mesothelioma - a Pilot Study

Sponsor

University Hospital, Lille

Enrollment

20 participants

Start Date

May 9, 2022

Study Type

INTERVENTIONAL

Conditions

Malignant Pleural Mesothelioma Mesotheliomas Pleural

Summary

Pilot study of the feasibility of an innovative multimodal treatment combining intrapleural photodynamic therapy with videothoracoscopy followed by adjuvant immunotherapy with anti-PD-1 Nivolumab antibodies in patients with malignant pleural mesothelioma

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of light-based therapy inside the chest (called photodynamic therapy, or PDT) plus an immunotherapy drug (nivolumab) for patients with a rare type of cancer that lines the lungs, called malignant pleural mesothelioma. **You may be eligible if...** - You have been diagnosed with mesothelioma (a cancer lining the lung cavity) that cannot be surgically removed - You have already tried one or two rounds of chemotherapy and the cancer has come back or grown - You are in generally good health (able to carry out daily activities with minimal limitations) - You have a procedure planned to drain fluid from your chest (thoracoscopy) - You lost less than 10% of your body weight recently **You may NOT be eligible if...** - You have already been treated with immunotherapy drugs (anti-PD-1 or anti-PD-L1) in the last 5 years - You are allergic to nivolumab - You are pregnant or breastfeeding - You have another active cancer diagnosed in the last 5 years - You have severe heart, kidney, or liver problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEintrapleural photodynamic therapy with videothoracoscopy

MPM patients will be first administrated 20 mg/kg of oral photosensitizer, 5-Aminolevulinic Acid (5-ALA) {Gliolan®}, 4 to 6 hours prior undergoing thoracoscopy (VATS). During VATS procedure, after a qualitative control of the fluorescence of tumor lesions and some guided pleural tumor biopsies, the pleural cavity will be illuminated using a flexible probe and laser source at a specific wavelength for 5-ALA (400-500 nm; 25 J/cm2) during 15 minutes (6 fractions of 2.5 minutes separated by 5 pauses of 2 minutes each to improve tissue oxygenation for the PDT reaction). An IPC device (but no talc) will be inserted and used for pleurodesis and may permit to collect further pleural effusion samples. As 5-ALA has a short half-life and thus does not need extensive precautions to avoid patient photosensitivity, the patient would not stay longer than a standard procedure (about 2-3 days in the hospital)

DRUGNivolumab Injection

Seven to 10 days after VATS, patients will start to be treated by Nivolumab 240mg IV every 2 weeks till progression (CT-scan reassessment every 8 cycles), unacceptable toxicity, or maximum 2 years.