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The IMmunotherapy Pleural 5-ALA PDT (IMPALA)

U

University Hospital, Lille

Status and phase

Enrolling
Phase 2

Conditions

Malignant Pleural Mesothelioma
Mesotheliomas Pleural

Treatments

Device: intrapleural photodynamic therapy with videothoracoscopy
Drug: Nivolumab Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT04400539
2019_41
2019-003003-35 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Malignant Pleural Mesothelioma patients
Experimental group
Treatment:
Drug: Nivolumab Injection
Device: intrapleural photodynamic therapy with videothoracoscopy

Trial contacts and locations

1

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Central trial contact

Arnaud Scherpereel, MD,PhD; Eric Wasielewski, PhD

Data sourced from clinicaltrials.gov

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