NCT04400539 The IMmunotherapy Pleural 5-ALA PDT
| NCT ID | NCT04400539 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital, Lille |
| Condition | Mesotheliomas Pleural |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-05-09 |
| Primary Completion | 2026-05-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2022-05-09 with a primary completion date of 2026-05-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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 * a previous treatment by anti-PD-1 or anti-PD-L1 antibodies for their cancer or any other cancer in the last 5 years * hypersensitivity to Nivolumab (anti-PD-1 antibodies) * contra-indications for 5-ALA or PDT * contra-indications for thoracoscopy (VATS) * 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 * other cancer treated within 5 years before inclusion except baso-cellular skin carcinoma or cervical / bladder in situ carcinoma * 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) * treatment with experimental drug within 30 days before the start of the study
Contact & Investigator
Arnaud Scherpereel, MD,PhD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT04400539 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mesotheliomas Pleural. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04400539 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04400539 currently recruiting?
Yes, NCT04400539 is actively recruiting participants. Contact the research team at arnaud.scherpereel@chru-lille.fr for enrollment information.
Where is the NCT04400539 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT04400539 clinical trial?
NCT04400539 is sponsored by University Hospital, Lille. The principal investigator is Arnaud Scherpereel, MD,PhD at University Hospital, Lille. The trial plans to enroll 20 participants.