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The IMmunotherapy Pleural 5-ALA PDT (IMPALA)

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ClinicalTrials.gov Identifier: NCT04400539
Recruitment Status : Recruiting
First Posted : May 22, 2020
Last Update Posted : January 9, 2023
Sponsor:
Collaborator:
INSERM U1189 ONCOTHAI
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Mesotheliomas Pleural Malignant Pleural Mesothelioma Device: intrapleural photodynamic therapy with videothoracoscopy Drug: Nivolumab Injection Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intrapleural Photodynamic Therapy by Video-Assisted Thoracoscopy Followed by Anti-PD-1 NIVOLUMAB in Patients With Malignant Pleural Mesothelioma - a Pilot Study
Actual Study Start Date : May 9, 2022
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma
Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Malignant Pleural Mesothelioma patients Device: intrapleural photodynamic therapy with videothoracoscopy
MPM patients will be first administrated 20 mg/kg of oral photosensitizer, 5-Aminolevulinic Acid (5-ALA) {Gliolan®}, 4 to 6 hours prior undergoing thoracoscopy (VATS). During VATS procedure, after a qualitative control of the fluorescence of tumor lesions and some guided pleural tumor biopsies, the pleural cavity will be illuminated using a flexible probe and laser source at a specific wavelength for 5-ALA (400-500 nm; 25 J/cm2) during 15 minutes (6 fractions of 2.5 minutes separated by 5 pauses of 2 minutes each to improve tissue oxygenation for the PDT reaction). An IPC device (but no talc) will be inserted and used for pleurodesis and may permit to collect further pleural effusion samples. As 5-ALA has a short half-life and thus does not need extensive precautions to avoid patient photosensitivity, the patient would not stay longer than a standard procedure (about 2-3 days in the hospital)

Drug: Nivolumab Injection
Seven to 10 days after VATS, patients will start to be treated by Nivolumab 240mg IV every 2 weeks till progression (CT-scan reassessment every 8 cycles), unacceptable toxicity, or maximum 2 years.
Other Name: adjuvant immunotherapy with anti-PD-1 Nivolumab antibodies


Outcome Measures
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Primary Outcome Measures :
  1. the proportion of patients having the full multimodal treatment [ Time Frame: through study completion, an average of 24 months ]
    the proportion of patients having the full multimodal treatment (target: 70% minimum of total patients,14 out of 20 patients) without inacceptable and unexpected toxicity (grade≥3) according National Cancer Institute (NCI) criteria, reviewed by an Independent Survey Committee.


Secondary Outcome Measures :
  1. objective response rate (ORR) according to modified RECIST 1.1 criteria for mesothelioma for pleural lesions; RECIST 1.1 for all other targets [ Time Frame: through study completion, an average of 24 months ]
  2. Kaplan Meier curve for overall survival (mOS) [ Time Frame: through study completion, an average of 24 months ]
  3. Kaplan Meier curve for progression free survival (mPFS) [ Time Frame: through study completion, an average of 24 months ]
  4. quality of life (QoL) of patients by dedicated EORTC QLQ C30 (or LCSS-30) questionnaire [ Time Frame: At baseline and ]
    The Quality of life questionnaire (QLQ-C30) contains 29 items dealing with fatigue, pain, nausea and vomiting, general condition and social, emotional and cognitive functions. It is currently used in many clinical trials in oncology

  5. evaluation of chest pain using visual scale. [ Time Frame: through study completion, an average of 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04400539


Contacts
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Contact: Arnaud Scherpereel, MD,PhD 320444998 ext +33 arnaud.scherpereel@chru-lille.fr
Contact: Eric Wasielewski, PhD 3.20.44.56.12 ext +33 eric.wasielewski@chru-lille.fr

Locations
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France
Institut Coeur-Poumon, CHU Recruiting
Lille, France, 59037
Sponsors and Collaborators
University Hospital, Lille
INSERM U1189 ONCOTHAI
Investigators
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Principal Investigator: Arnaud Scherpereel, MD,PhD University Hospital, Lille
More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04400539    
Other Study ID Numbers: 2019_41
2019-003003-35 ( EudraCT Number )
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: January 9, 2023
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Immunotherapy
anti-PD-1
Photodynamic Therapy
Additional relevant MeSH terms:
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Mesothelioma
Mesothelioma, Malignant
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Pleural Neoplasms
Lung Diseases
Respiratory Tract Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action