The IMmunotherapy Pleural 5-ALA PDT

PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 9, 2022

Primary Completion Date

May 9, 2026

Study Completion Date

May 9, 2026

Conditions
Mesotheliomas PleuralMalignant Pleural Mesothelioma
Interventions
DEVICE

intrapleural 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)

DRUG

Nivolumab 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.

Trial Locations (1)

59037

RECRUITING

Institut Coeur-Poumon, CHU, Lille

All Listed Sponsors
collaborator

INSERM U1189 ONCOTHAI

UNKNOWN

lead

University Hospital, Lille

OTHER