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

NCT05973344 | Recruiting

• 2 other identifiers: 29BRC22.0189 (TADIG-P)2022-A02237-36
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to explore the value of blood biomarkers for the purpose of predicting irAE development in cancer patients treated with immune checkpoint inihibitors (ICI) alone or in combination with other treatments (chemotherapy, radiotherapy and targeted therapy). Data and blood samples will be collected from participants at different time points as part of routine follow-up visits. Data and blood samples will be analysed. Analysis will include the characterization of immune cells by mass and flow cytometry.

Conditions

Cancer

Keywords

immunotherapy

Outcome Measures

Primary Outcomes (1)

• Occurrence of irAE over the duration of the patient's follow-up

  Apparition of irAE is appreciated according the physician definition. The description and grading scales of irAE found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0. A copy of the CTCAE version 5.0 can be downloaded from the CTEP web site http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.

  36 months

Secondary Outcomes (3)

• Survival (PFS).

  36 months

• Survival (OS).

  36 months

• Tumor response according to the iRECIST criteria

  36 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with tumors treated with ICI (anti-CTLA-4, anti-PD-1/PD-L1, LAG3, etc.) as standard-of-care, alone or in combination with other treatments (chemotherapy, radiotherapy and targeted therapy)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Brest University Hospital

Brest, 29200, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Benjamin Auberger

  CHU Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Auberger

CONTACT

+33298223740; benjamin.auberger@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 2, 2023
• Study Start: February 9, 2024
• Primary Completion (Estimated): February 9, 2030
• Study Completion (Estimated): February 9, 2030
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

FR (1)