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NCT Number: NCT05813418

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

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.

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Key information

Conditions

Immunotherapy Immune Checkpoint Inhibitors Immune-related Adverse Event Predictive Biomarkers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location status: Recruiting

Location contact

Aurélie MOREIRA, MD

SUB_INVESTIGATOR

Charles DAYEN, MD

SUB_INVESTIGATOR

Claire POULET, MD

SUB_INVESTIGATOR

Gwladys BOURDENET, Dr

CONTACT

[email protected]

03.22.08.70.72

Jean-Philippe ARNAULT, MD

SUB_INVESTIGATOR

Vincent Hautefeuille, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient with cancer, whatever initial tumoral histology and disease stage under ICPI treatment (anti-PD1 and/or anti-CTLA-4)
  • age > 18
  • followed in oncology, pneumology, dermatology, gastroenterology departments of Amiens-Picardie University Hospital or Saint Quentin hospital
  • who received verbal and written information, and signed the consent form for the study

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 of possible lower response to ICPI treatment when associated)

Treatment and study plan

blood retriewal

Biological

blood retriewal for cytokine concentration measurement

Primary outcomes

  1. Variation from baseline of IL6 concentration in riAEs patients

    Time frame: 6 months

    Variation from baseline of IL6 concentration (pG/mL) in riAEs patients

  2. Variation from baseline of IL10 concentration in riAEs patients

    Time frame: 6 months

    Variation from baseline of IL10 concentration (pG/mL) in riAEs patients

  3. Variation from baseline of IL15 concentration in riAEs patients

    Time frame: 6 months

    Variation from baseline of IL15 concentration (pG/mL) in riAEs patients

  4. Variation from baseline of IL8 concentration in riAEs patients

    Time frame: 6 months

    Variation from baseline of IL8 concentration (pG/mL) in riAEs patients

  5. Variation from baseline of INFgamma concentration in riAEs patients

    Time frame: 6 months

    Variation from baseline of INFgamma concentration (pG/mL) in riAEs patients

  6. Variation from baseline of MCP-1 concentration in riAEs patients

    Time frame: 6 months

    Variation from baseline of MCP-1 concentration (pG/mL) in riAEs patients

  7. Variation from baseline of MIP 1 alpha concentration in riAEs patients

    Time frame: 6 months

    Variation from baseline of MIP 1 alpha concentration (pG/mL) in riAEs patients

  8. Variation from baseline of MIP 1 beta concentration in riAEs patients

    Time frame: 6 months

    Variation from baseline of MIP 1 beta concentration (pG/mL) in riAEs patients

  9. Variation from baseline of sIL2R concentration in riAEs patients

    Time frame: 6 months

    Variation from baseline of sIL2R concentration (U/mL) in riAEs patients

  10. Variation from baseline of sIL6R concentration in riAEs patients

    Time frame: 6 months

    Variation from baseline of sIL6R concentration (µG/mL) in riAEs patients

Study contacts

Contact information is provided by the study sponsor or research team.

Gwladys BOURDENET, DR

CONTACT

[email protected]

03.22.08.70.72

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Central Hospital Saint Quentin

Registry information

Official study title

Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients

Acronym: Ibe2i-TIPCI

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2023
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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