Health TrialsbyHealthPanel

The IMmunotherapy Pleural 5-ALA PDT

ConditionsMesotheliomas PleuralMalignant Pleural Mesothelioma
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • intrapleural photodynamic therapy with videothoracoscopy

    Device

    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)

  • Nivolumab Injection

    Drug

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Malignant Pleural Mesothelioma patientsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

the proportion of patients having the full multimodal treatment

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.

Time frame
through study completion, an average of 24 months

Secondary outcomes

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

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

Time frame
At baseline and

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Lille

Lead sponsor

INSERM U1189 ONCOTHAI

Collaborator

Source ClinicalTrials.gov
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