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New treatment option for Mesotheliomas Pleural
Official title The IMmunotherapy Pleural 5-ALA PDT
ClinicalTrials.gov ID: NCT04400539
What this study is testing
What is Nivolumab Injection?
Nivolumab Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for mesotheliomas pleural.
Also referred to as adjuvant immunotherapy with anti-PD-1 Nivolumab antibodies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Documented progression after previous 1 or 2 lines of chemotherapy including Platinum/Pemetrexed chemotherapy\
- Measurable disease according to modified RECIST 1.1. for MPM
You likely can't join if
- 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...
- 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...
- 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
See the full eligibility 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...
- 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...
- 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.
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lille, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.