Actively Recruiting
The IMmunotherapy Pleural 5-ALA PDT
Led by University Hospital, Lille · Updated on 2025-09-25
20
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Lille
Lead Sponsor
I
INSERM U1189 ONCOTHAI
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
The IMmunotherapy Pleural 5-ALA PDT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG Performance status 0-1 (WHO)
- Unresectable malignant pleural mesothelioma
- Patients relapsing after one or two lines of platinum-based doublet chemotherapy including pemetrexed, or those with contraindications to or refusal of chemotherapy
- Candidate for palliative pleural procedure such as thoracoscopy for pleurodesis or indwelling pleural catheter insertion
- Documented disease progression after prior chemotherapy
- Measurable disease per modified RECIST 1.1 for MPM
- Malignant pleural lesion accessible for photodynamic therapy during thoracoscopy as validated by expert board
- Histological diagnosis confirmed by national expert pathology panel
- Weight loss less than 10%
- Available tumor tissue sample (archival or fresh)
- Signed informed consent before any study procedures
- Treatment decision made by dedicated multidisciplinary board
- Affiliated with and covered by social security
- Women of child-bearing potential must use effective contraception starting 28 days before treatment and continuing for 5 months after final dose
- Women of child-bearing potential must have negative pregnancy test within 24 hours before treatment
- First line patients may be included if declining or contraindicated for chemotherapy
You will not qualify if you...
- Lack of signed informed consent or refusal to participate
- Pregnant or breastfeeding women, or women not willing/able to use effective contraception during study and 5 months after last dose
- Male patients unwilling/unable to use contraception during study and for 7 months after last dose
- Previous anti-PD-1 or anti-PD-L1 antibody treatment within last 5 years
- Hypersensitivity to Nivolumab
- Contraindications to 5-ALA or photodynamic therapy
- Contraindications for thoracoscopy (VATS)
- Comorbidities preventing protocol feasibility such as uncontrolled heart failure, pulmonary hypertension, severe liver or kidney dysfunction, uncontrolled infection, or other investigator-assessed diseases
- Other cancers treated within 5 years except basal cell skin carcinoma or in situ cervical/bladder carcinoma
- Inability to understand study information or provide consent
- Inability to attend clinical follow-up due to psychological, social, family, or geographic reasons
- Legal incapacity or under legal supervision
- Treatment with experimental drug within 30 days before study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institut Coeur-Poumon, CHU
Lille, France, 59037
Actively Recruiting
Research Team
A
Arnaud Scherpereel, MD,PhD
CONTACT
E
Eric Wasielewski, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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