The IMmunotherapy Pleural 5-ALA PDT

Sponsor
University Hospital, Lille
Study ID
NCT04400539
Phase
PHASE2
Status
Recruiting
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Conditions

  • Malignant Pleural Mesothelioma
  • Mesotheliomas Pleural

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • intrapleural photodynamic therapy with videothoracoscopy — DEVICE
    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)
  • Nivolumab Injection — DRUG
    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.

Study Details

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

Key Dates

Start date
May 9, 2022
Status verified
Sep 2025
Primary completion
May 9, 2026
Completion
May 9, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Malignant Pleural Mesothelioma patients

Primary Outcome Measure

the proportion of patients having the full multimodal treatment [ Time Frame: through study completion, an average of 24 months ]

Central Contacts

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