Light therapy inside the chest, then nivolumab, for pleural mesothelioma
Tests light therapy in the chest followed by nivolumab in adults with pleural mesothelioma.
Plain-language title generated from the registry record
Registry title: The IMmunotherapy Pleural 5-ALA PDT
Key facts
- Where
- Lille, FranceSee the site
- Phase
- Phase 2
Where in France
- Centre Hospitalier Universitaire de LilleLille, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Lille
- Trial code
- NCT04400539EU 2024-514103-33-00
- Record updated
- 25 September 2025
- Original description
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 mesotheliomaRead full original descriptionShow less
Intrapleural Photodynamic Therapy by Video-Assisted Thoracoscopy Followed by Anti-PD-1 NIVOLUMAB in Patients With Malignant Pleural Mesothelioma - a Pilot Study
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
Inclusion: ECOG Performance status (PS) 0-1 (WHO); Unresectable Malignant Pleural Mesothelioma; suffering from unresectable MPM (n=20), relapsing after one or 2 lines of treatment with platinum-based doublet of chemotherapy (including pemetrexed) [Note: MPM patients having contra-indications for, or refusing chemotherapy may also be recruited], and candidate for palliative pleural procedure (i.e. thoracoscopy for pleurodesis by talc or by insertion of indwelled pleural catheter, IPC); Documented progression after previous 1 or 2 lines of chemotherapy including Platinum/Pemetrexed chemotherapy*; Measurable disease according to modified RECIST 1.1. for MPM; Malignant pleural lesion assessed to be accessible by local PDT treatment during thoracoscopy, as validated by expert MTB ("MESOCLIN", Lille, France); Histological diagnosis confirmed by national expert pathology panel ("MESOPATH" - Institut Léon Bérard, Lyon, France); Weight loss <10%; available tumor tissue (archival or fresh); obtention of an informed written consent before any specific procedure of the study; Decision to treat the patient within this clinical trial taken during MPM dedicated multidisciplinary board (RCP MESOCLIN in France ); Patient affiliated to and covered by social security for standard care; Women of child-bearing potential must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 5 months after the final dose of investigational product; Women of child-bearing potential must have a negative pregnancy test within 24h before administration of investigational product; First line patients may also be recruited if they declined or if they have contra-indications for chemotherapy.
Exclusion: a previous treatment by anti-PD-1 or anti-PD-L1 antibodies for their cancer or any other cancer in the last 5 years; treatment with experimental drug within 30 days before the start of the study; hypersensitivity to Nivolumab (anti-PD-1 antibodies); other cancer treated within 5 years before inclusion except baso-cellular skin carcinoma or cervical / bladder in situ carcinoma; any other comorbidity precluding the feasibility of the therapeutic protocol: uncontrolled cardiac failure, pulmonary hypertension, liver or kidney severe dysfunction (creatinin clearance <60 ml/min), uncontrolled infection, or other disease according to the investigator; lack of informed written consent; or refusal to sign or to participate; Pregnant, breastfeeding patients, and female patients of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in the protocol for the duration of the study and for at least 5 months after the last dose of nivolumab; Male patients who are unwilling or unable to use contraception methods for the duration of the study and for at least 7 months after the last dose of nivolumab; contra-indications for 5-ALA or PDT; contra-indications for thoracoscopy (VATS); inability to receive study information and to give informed consent; patient unable to have a clinical follow-up due to psychological, familial, social or geographical reasons; legal incapacity (people in jail), or under supervision (i.e. guardianship or curatorship).