Clinical trial · Interventional
The IMmunotherapy Pleural 5-ALA PDT
Intrapleural Photodynamic Therapy by Video-Assisted Thoracoscopy Followed by Anti-PD-1 NIVOLUMAB in Patients With Malignant Pleural Mesothelioma - a Pilot Study
NCT04400539CI-TRIAL-00095777IMPALArecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Pleural Mesothelioma | Pleural Malignant Mesothelioma | ALIAS | 0.90 |
| Mesotheliomas Pleural | Malignant Mesothelioma | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intrapleural photodynamic therapy with videothoracoscopy | Device | — | UNRESOLVED |
| Nivolumab Injection | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Malignant Pleural Mesothelioma patients
- interventionNames
- Device: intrapleural photodynamic therapy with videothoracoscopy
- Drug: Nivolumab Injection
Primary outcomes (1)
- measure
- the proportion of patients having the full multimodal treatment
- timeFrame
- through study completion, an average of 24 months
- description
- the proportion of patients having the full multimodal treatment (target: 70% minimum of total patients,14 out of 20 patients) without inacceptable and unexpected toxicity (grade≥3) according National Cancer Institute (NCI) criteria, reviewed by an Independent Survey Committee.
Secondary outcomes (5)
- measure
- objective response rate (ORR) according to modified RECIST 1.1 criteria for mesothelioma for pleural lesions; RECIST 1.1 for all other targets
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 studyReferences
Publications (0)
Data not yet available
No reference posted for this study.