Exploring blood biomarkers to predict immune-related side effects in cancer treatment

Understanding and Anticipating Therapeutic and ADverse Responses in Anti-cancer Immune Checkpoint Inhibition Towards a Better Therapeutic Management of Patients

This study is testing if certain blood markers can help predict immune-related side effects in cancer patients receiving immune treatments.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Brest (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Brest)
• Trial ID: NCT05973344 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the role of blood biomarkers in predicting the development of immune-related adverse events (irAEs) in cancer patients undergoing treatment with immune checkpoint inhibitors (ICIs), either alone or in combination with other therapies. Participants will have their blood samples and clinical data collected during routine follow-up visits, which will be analyzed to characterize immune cell populations using advanced techniques like mass and flow cytometry. The study seeks to identify specific immune mechanisms that contribute to irAEs, which can vary significantly among patients and tumor types.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with confirmed tumors eligible for treatment with immune checkpoint inhibitors.

Not a fit: Patients who are not eligible for immune checkpoint inhibitors or have contraindications to blood sample collection may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of cancer patients by predicting and mitigating adverse effects associated with immunotherapy.

How similar studies have performed: While the approach of using biomarkers to predict adverse events in immunotherapy is being explored, this specific study's focus on irAEs in a real-world setting is relatively novel.

Eligibility criteria

* Age ≥ 18 years old
* ECOG performance status ≤ 1
* Must have histologically or cytologically confirmed tumour, eligible for treatment with ICI as standard-of-care alone or in combination with another ICI, ICI with chemotherapy, ICI with radiotherapy, or ICI with targeted therapy with no restrictions on number of prior systemic therapies
* Adequate bone marrow function as defined below

  * Absolute neutrophil count ≥ 1500/µL or 1.5x109/L
  * Hemoglobin ≥ 9 g/dL
  * Platelets ≥ 100000/µL or 100x109/L
* Adequate liver function as defined below

  * Serum total bilirubin ≤ 1.5 x ULN. In case of known Gilbert's syndrome \< 3xUNL is allowed
  * AST (SGOT)/ALT (SGPT) ≤ 3.0 x ULN
  * Alkaline phosphatase ≤ 3.3 x ULN
* Adequate renal function as defined below

  \_- Creatinine ≤ 1.5 x UNL or creatinine clearance \> 60 mL/min
* Patient monitored for their cancer at CHU of Brest
* Did not oppose for their samples and clinical data to be used for translational research
* Non-opposition form obtained prior to any study related procedure

Exclusion Criteria:

* Patient with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study
* Patient already receiving ICI
* Primary immunodeficiency and/or history of allogenic transplantation
* Current active infection
* Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection)
* Subject of guardianship (tutorship, curatorship)
* Active pregnancy

Where this trial is running

Brest

• Brest University Hospital — Brest, France (Recruiting)

Study contacts

• Principal investigator: Benjamin Auberger — CHU Brest
• Study coordinator: Benjamin Auberger

Conditions Cancer; immunotherapy