the immunotherapy pleural 5-ala pdt

Conditions: Mesotheliomas Pleural; Malignant Pleural Mesothelioma

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

Keywords: immunotherapy anti-pd-1 photodynamic therapy