The IMmunotherapy Pleural 5-ALA PDT (IMPALA)

University Hospital, Lille

Status and phase

Enrolling

Phase 2

Conditions

Malignant Pleural Mesothelioma

Mesotheliomas Pleural

Treatments

Device: intrapleural photodynamic therapy with videothoracoscopy

Drug: Nivolumab Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT04400539

2019_41

2019-003003-35 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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