Predicting immune-related side effects in solid cancers treated with immune therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to identify biomarkers that forecast immune-related adverse events (iRAEs) in patients with solid tumors receiving immune checkpoint inhibitors. It will collect blood, pharyngeal and cutaneous swabs, and stool samples around treatment initiation to explore predictive signatures. Eligible participants are adults with a confirmed solid tumor starting an anti-PD1/PD-L1, anti-CTLA-4, or anti-LAG3 therapy, alone or in combination, as part of standard care. The study focuses on early prediction of potentially life-threatening irAEs to enable proactive management. Results could inform personalized monitoring and safer use of immunotherapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patient (≥18 years old)
* Patient presenting an histologically or cytologically confirmed solid tumour malignancy
* Patient scheduled to receive his/her first infusion of immunotherapy with anti-PD1, anti-PDL1, anti-CTLA4, anti-LAG3, alone or in combination, as part of standard care, in all validated solid oncology indications.
* Patient must have at least one measurable lesion according to RECIST 1.1 criteria
* Patient treated at AP-HM in one of the CEPCM-affiliated departments.
* Patient able to comply with study procedures and follow-up schedule
* Patient who has been informed about the study and signed the consent form
* Patient who is a beneficiary or entitled beneficiary of a social security scheme

Exclusion Criteria:

* Patient previously treated with ICIs
* Patient whose treatment plan includes targeted therapy, chemotherapy or any other systemic treatment in combination with ICI
* Patient included in a trial with an experimental molecule
* Patient has an active autoimmune disease or any other pathology requiring systemic corticosteroid therapy at more than 10 mg prednisone equivalent per day or any other immunosuppressive drug
* Patients with a history of organ transplantation, hematopathy or hematopoietic stem cell transplantation
* Patient with history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
* Patient in emergency situations, persons deprived of their liberty by judicial or administrative decision, adults subject to legal protection measures, or persons who are unable to give their consent, or pregnant or breastfeeding.

Where it's running

• Assistance Publique Hôpitaux de marseille
  Marseille, France Recruiting

Study contacts

• Study coordinator: Nausicaa Malissen, dr
• Email: NAUSICAA.MALISSEN@ap-hm.fr
• Phone: 0491435817

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.