The IMmunotherapy Pleural 5-ALA PDT

Brief Title

The IMmunotherapy Pleural 5-ALA PDT

Official Title

Intrapleural Photodynamic Therapy by Video-Assisted Thoracoscopy Followed by Anti-PD-1 NIVOLUMAB in Patients With Malignant Pleural Mesothelioma - a Pilot Study

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
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

the proportion of patients having the full multimodal treatment

Secondary Outcome

 objective response rate (ORR) according to modified RECIST 1.1 criteria for mesothelioma for pleural lesions; RECIST 1.1 for all other targets

Condition

Mesotheliomas Pleural

Intervention

intrapleural photodynamic therapy with videothoracoscopy

Study Arms / Comparison Groups

 Malignant Pleural Mesothelioma patients

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

20

Start Date

September 2020

Completion Date

September 2024

Primary Completion Date

September 2024

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Arnaud Scherpereel, MD,PhD, 320444998, [email protected]

NCT ID

NCT04400539

Organization ID

2019_41

Secondary IDs

2019-003003-35

Responsible Party

Sponsor

Study Sponsor

University Hospital, Lille

Collaborators

 Bristol-Myers Squibb

Study Sponsor

Arnaud Scherpereel, MD,PhD, Principal Investigator, University Hospital, Lille

Verification Date

April 2020