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IMPALA Protocol: Intrapleural Photodynamic Therapy by Video-Assisted Thoracoscopy Followed by Anti-PD-1 NIVOLUMAB in Patients With Malignant Pleural Mesothelioma - a Pilot Study -
EU CTIS ID: 2024-514103-33-00
What this study is testing
The main objective of this study is to demonstrate the feasibility of the innovative therapeutic strategy combining intrapleural PDT by VATS then immunotherapy by Nivolumab in MPM patients without inacceptable and unexpected toxicity.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients (male or female) ≥18 years old (n=20)
- Weight loss <10%
- Available tumor tissue (archival or fresh)
- No contraindications to 5-ALA, PDT or Nivolumab
- 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 NETMESO/ MESOCLIN in France )
You likely can't join if
- Lack of informed written consent; or refusal to sign or to participate
- 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
- 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
See the full eligibility criteria
Who can join
- Patients (male or female) ≥18 years old (n=20)
- Weight loss <10%
- Available tumor tissue (archival or fresh)
- No contraindications to 5-ALA, PDT or Nivolumab
- 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 NETMESO/ 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
- 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* *First line patients may also be recruited if they declined or if they have contra-indications for chemotherapy.
- Patient eligible for Nivolumab as validated by expert MTB (“NETMESO/MESOCLIN” French network, Lille, France), and in accordance with RTU procedure for drug access
- Measurable disease according to modified RECIST 1.1. for MPM (Nowak and Armato, J Thorac Oncol 2018)
- Malignant pleural lesion assessed to be accessible by local PDT treatment during thoracoscopy, as validated by expert MTB (“NETMESO/MESOCLIN” French network, Lille, France)
- Histological diagnosis confirmed by local and/or national (Institut Léon Bérard, Lyon, France) expert pathology panel of the “NETMESO/MESOPATH” French network
What rules you out
- Lack of informed written consent; or refusal to sign or to participate
- 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
- 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, with the exception of the Nivolumab + Ipilimumab combination, or (platinum/pemetrexed) + immunotherapy as alternative first line treatments in pleural mesothelioma.
- Usual contra-indications for anti-PD-1 antibodies (Nivolumab) 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 clairance <60 ml/min), uncontroled 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
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.