New combo therapy targets hard-to-treat mesothelioma
NCT ID NCT04400539
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new two-step treatment for people with malignant pleural mesothelioma, a rare and serious cancer of the lung lining. First, doctors use a special light therapy during a scope procedure to kill cancer cells. Then, patients receive an immunotherapy drug called nivolumab to help the immune system attack remaining cancer. The goal is to see if this combination is safe and feasible for 20 patients whose cancer has returned after chemotherapy.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2022
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Institut Coeur-Poumon, CHU
RECRUITINGLille, 59037, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a pill that blocks multiple cancer proteins shrink Hard-to-Treat tumors?
- Engineered immune cells take aim at Mesothelin-Positive tumors
- Triple-Drug cocktail targets Hard-to-Treat mesothelioma
- New antibody-chemo combo shows promise for mesothelioma
- Triple threat: new combo tackles rare lung cancer