IMPALA

THE IMMUNOTHERAPY PLEURAL 5-ALA PDT “IMPALA” trial: Intrapleural Photodynamic Therapy by Video-Assisted Thoracoscopy followed by Anti-PD-1 NIVOLUMAB in Patients with Malignant Pleural Mesothelioma- a pilot study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003003-35-FR

Enrollment

Registered

2020-03-03

Start date

2020-05-15

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Nivolumab solution for injection Product Name: Nivolumab Product Code: BMS936558 Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients (male or female) =18 years old (n=20) 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 (Nowak and Armato, J Thorac Oncol 2018) 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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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 Usual contra-indications for anti-PD-1 antibodies (Nivolumab) 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 clairance <60 ml/min), uncontroled 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this study is to demonstrate the feasibility of the innovative therapeutic strategy combining intrapleural PDT by VATS then immunotherapy by Nivolumab in MPM patients without inacceptable and unexpected toxicity.;Secondary Objective: (a) to describe patients outcome (b) to assess the impact of experimental treatment on quality of life and chest pain;Primary end point(s): Proportion of patients having the full multimodal treatment (target: 70% minimum of total patients, i.e. 14 out of 20 patients) without inacceptable and unexpected toxicity (grade=3) according National Cancer Institute (NCI) criteria, reviewed by an Independent Survey Committee.;Timepoint(s) of evaluation of this end point: At the end of the treatment for each patient	—

Measure

Time frame

Main Objective: The main objective of this study is to demonstrate the feasibility of the innovative therapeutic strategy combining intrapleural PDT by VATS then immunotherapy by Nivolumab in MPM patients without inacceptable and unexpected toxicity.;Secondary Objective: (a) to describe patients outcome (b) to assess the impact of experimental treatment on quality of life and chest pain;Primary end point(s): Proportion of patients having the full multimodal treatment (target: 70% minimum of total patients, i.e. 14 out of 20 patients) without inacceptable and unexpected toxicity (grade=3) according National Cancer Institute (NCI) criteria, reviewed by an Independent Survey Committee.;Timepoint(s) of evaluation of this end point: At the end of the treatment for each patient

—

Secondary

Measure	Time frame
Secondary end point(s): (a)objective response rate (ORR), progression free survival (PFS), and overall survival (OS); (b)score Meso LCSS-30, and EVA scale;Timepoint(s) of evaluation of this end point: (a) at the end of the study (LVLS) (b) throughout the study (screening, treatment, end of treatment)	—

Countries

France

Contacts

Public ContactLANGLOIS Audrey

CHU de Lille

audrey.langlois@chru-lille.fr+330320444145

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026