Malignant Pleural Mesothelioma Clinical Trial
— IMPALAOfficial title:
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
Status | Recruiting |
Enrollment | 20 |
Est. completion date | May 2026 |
Est. primary completion date | May 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Institut Coeur-Poumon, CHU | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille | INSERM U1189 ONCOTHAI |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the proportion of patients having the full multimodal treatment | 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. | through study completion, an average of 24 months | |
Secondary | objective response rate (ORR) according to modified RECIST 1.1 criteria for mesothelioma for pleural lesions; RECIST 1.1 for all other targets | through study completion, an average of 24 months | ||
Secondary | Kaplan Meier curve for overall survival (mOS) | through study completion, an average of 24 months | ||
Secondary | Kaplan Meier curve for progression free survival (mPFS) | through study completion, an average of 24 months | ||
Secondary | quality of life (QoL) of patients by dedicated EORTC QLQ C30 (or LCSS-30) questionnaire | The Quality of life questionnaire (QLQ-C30) contains 29 items dealing with fatigue, pain, nausea and vomiting, general condition and social, emotional and cognitive functions. It is currently used in many clinical trials in oncology | At baseline and | |
Secondary | evaluation of chest pain using visual scale. | through study completion, an average of 24 months |
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