The IMmunotherapy Pleural 5-ALA PDT
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille
About this trial
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
Qualifiers
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*
Disqualifiers
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
Trial design
Treatments tested in this trial
- intrapleural photodynamic therapy with videothoracoscopy
- Nivolumab Injection
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
University Hospital, Lille
Lead sponsor
INSERM U1189 ONCOTHAI
Collaborator
Source ClinicalTrials.gov