Phase 2 Mesothelioma Trial, Recruiting NCT04400539 Sponsor: University Hospital, Lille Condition: Mesothelioma
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Phase 2 Mesothelioma Trial, Recruiting

NCT04400539
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are generally able to carry out daily activities without much difficulty (good physical functioning, confirmed with trial site)
  • You have been diagnosed with a type of cancer affecting the lining of the lung (malignant pleural mesothelioma) that cannot be removed by surgery
  • Your cancer has come back or progressed after 1 or 2 rounds of standard chemotherapy, OR you are unable to have chemotherapy or have chosen not to have it
  • You are already being considered for a procedure involving a camera examination of the chest cavity (thoracoscopy) to help manage fluid buildup
  • Your cancer can be seen and measured on scans using standard criteria for this type of cancer
  • The cancer areas in the chest lining are in a position where a light-based treatment (photodynamic therapy/PDT) can be applied during the chest procedure (confirm with trial site)
  • Your diagnosis has been confirmed by a specialist national panel of cancer pathologists
  • You have lost less than 10% of your body weight
  • There is tumor tissue available (either recently collected or stored from a previous biopsy)
  • You have given written consent to take part before any study procedures begin
  • Your case has been reviewed and approved by a specialist mesothelioma medical team in France
  • You are covered by French social security for standard care
  • If you are a woman who could become pregnant, you must use a highly effective form of contraception starting 28 days before the first treatment and continuing for 5 months after the last dose
  • If you are a woman who could become pregnant, you must have a negative pregnancy test within 24 hours before receiving the study treatment

Who may not be able to join:

  • You are unwilling or unable to give written informed consent to take part
  • You are pregnant, breastfeeding, or are a woman who could become pregnant and are unwilling or unable to use effective contraception during the study and for at least 5 months after the last dose of the study drug (nivolumab)
  • You are a man who is unwilling or unable to use contraception during the study and for at least 7 months after the last dose of nivolumab
  • You have previously been treated with a type of immunotherapy drug called an anti-PD-1 or anti-PD-L1 antibody (for this or any other cancer) in the last 5 years
  • You have a known allergy or serious reaction to nivolumab
  • You have a medical reason that prevents you from receiving the light-based treatment (PDT) or the drug used with it (5-ALA) (confirm with trial site)
  • You have a medical reason that prevents you from having the chest camera procedure (thoracoscopy)
  • You have another serious health condition that could make the treatment unsafe, such as uncontrolled heart failure, high blood pressure in the lungs, severe liver or kidney problems, or an uncontrolled infection
  • You have been treated for another type of cancer within the last 5 years (exceptions may apply for certain minor skin cancers or early-stage cancers — confirm with trial site)
  • You are unable to understand the study information or give informed consent
  • You are unable to attend regular follow-up appointments due to personal, family, social, or location-related reasons
  • You are currently in prison or are under a legal guardianship arrangement
  • You have taken part in another experimental drug trial within 30 days before joining this study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Arnaud Scherpereel, MD,PhD, University Hospital, Lille

Phone: 320444998

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
9 May 2022
Est. completion
9 May 2026

Where this trial is recruiting

🇫🇷 France

Primary endpoints

the proportion of patients having the full multimodal treatment

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov