The IMmunotherapy Pleural 5-ALA PDT

Launched by UNIVERSITY HOSPITAL, LILLE · May 20, 2020

Keywords

ClinConnect Summary

This clinical trial, called the IMmunotherapy Pleural 5-ALA PDT, is exploring a new treatment approach for patients with malignant pleural mesothelioma, a type of cancer that affects the lining of the lungs. The study aims to combine a special light-based therapy, known as photodynamic therapy (PDT), with a procedure called videothoracoscopy to help target the cancer. After this initial treatment, participants will receive an immunotherapy drug called Nivolumab, which helps the body's immune system fight the cancer more effectively.

To participate in this trial, patients need to be between 65 and 74 years old and have a diagnosis of unresectable (non-surgical) malignant pleural mesothelioma that has not responded well to previous treatments. Other key factors for eligibility include having a good performance status (meaning they are still able to carry out daily activities) and a measurable cancer that can be treated with the light therapy. Participants can expect to undergo several procedures and treatments while being closely monitored by healthcare professionals. It’s important to note that patients must provide informed consent and meet specific health criteria to ensure their safety during the study.

Gender

ALL

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