Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Malignant Mesothelioma

All Drugs and Chemicals

Antineoplastic Agents

Dermatologic Agents

Antibodies

Immunomodulating Agents

Nivolumab

Aminolevulinic Acid

Immunoglobulins

Photosensitizing Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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)

intrapleural photodynamic therapy with videothoracoscopy

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.

Nivolumab Injection

Arnaud Scherpereel, MD,PhD

Eric Wasielewski, PhD

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

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

the proportion of patients having the full multimodal treatment (target: 70% minimum of total patients,14 out of 20 patients) without inacceptable and unexpected toxicity (grade≥3) according National Cancer Institute (NCI) criteria, reviewed by an Independent Survey Committee.

The Quality of life questionnaire (QLQ-C30) contains 29 items dealing with fatigue, pain, nausea and vomiting, general condition and social, emotional and cognitive functions. It is currently used in many clinical trials in oncology

INSERM U1189 ONCOTHAI

University Hospital, Lille

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The IMmunotherapy Pleural 5-ALA PDT	NCT04400539	Mesotheliomas P... Malignant Pleur...	intrapleural ph... Nivolumab Injec...	18 Years -	University Hospital, Lille
The IMmunotherapy Pleural 5-ALA PDT	NCT04400539	Mesotheliomas P... Malignant Pleur...	intrapleural ph... Nivolumab Injec...	18 Years -	University Hospital, Lille

Spots Global Cancer Trial Database for intrapleural photodynamic therapy with videothoracoscopy