Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients Undergoing Immune CheckPoint Inhibitors (ICPI) Treatment

Last updated: June 3, 2025
Sponsor: Centre Hospitalier Universitaire, Amiens
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vaccines

Cancer Treatment

Chemotherapy

Treatment

blood retriewal

Clinical Study ID

NCT05813418
PI2019_843_0078
  • Ages > 18
  • All Genders

Study Summary

In the last decades, cancer treatment was based on surgery, radiotherapy and chemotherapy.

Recently, treatments have largely evolved, first with targeted therapies (notably tyrosin kinase inhibitors, TKI) and then with immune checkpoint inhibitors (ICPI, notably anti-CTLA-4 and anti- PD1). The last ones can induce durable anti-tumoral responses in patients, even if metastases are present. Their mechanisms of action are focused on the activation of immune system in order to eliminate the tumor. ICPI, because of their mechanisms of action, target immune tolerance key components and can induce important immune toxicities (colitis, hepatitis, dermatitis, thyroiditis ...), leading to early discontinuation of treatment, severe or chronic morbidity, and can sometimes be lethal. It is of importance to detect patient at risk of irAEs, because of the increasing use of ICPI and the long- term response capacity in treated patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patient with cancer, whatever initial tumoral histology and disease stage under ICPItreatment (anti-PD1 and/or anti-CTLA-4)

  • age > 18

  • followed in oncology, pneumology, dermatology, gastroenterology departments ofAmiens-Picardie University Hospital or Saint Quentin hospital

  • who received verbal and written information, and signed the consent form for thestudy

Exclusion

Exclusion Criteria:

  • non ICPI treated patients

  • patient who received a first line of ICPI treatment

  • patient who received or is receiving MEK inhibitors as a treatment (because ofpossible lower response to ICPI treatment when associated)

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: blood retriewal
Phase:
Study Start date:
July 02, 2021
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • CHU Amiens Picardie

    Amiens, Picardie 80054
    France

    Active - Recruiting

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