Immunological Variables Associated to ICI Toxicity in Cancer Patients

July 1, 2022 updated by: Mireille Langouo Fontsa, Jules Bordet Institute

This is a monocentric, prospective, pilot study that will enrol 435 subjects with solid tumours that are treated with immune checkpoint inhibitor(s) (ICI) alone or in combination with chemotherapy or targeted therapy.

For enrolled subjects, clinical and laboratory evaluations will be performed and reported at different time points:

  • Early (4-6 weeks after treatment start)
  • Midtime (8-11 weeks after treatment start)
  • Late (13-18 weeks after treatment start)

  • At the occurrence of immune-related adverse events (irAEs), clinical and laboratory evaluation will be performed at two principal time points:

    • For the 1st time of any grade 1 or 2 irAE if the subject developed it.
    • For the 1st time of any grade 3 or 4 irAE if the subject developed it.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Advances in treating patients with immunotherapy has dramatically changed cancer morbidity and mortality. Immune checkpoint inhibitors (ICI), alone or combined with other drugs, are currently used both as standard of care or in experimental settings for various cancers. Currently, ICI treatment induces objective clinical responses in 20-40% of patients, which varies by tumour type. A significant risk of immune-related adverse events (irAE) is also associated with ICI treatment, including the onset of autoimmune diseases. While the incidence of irAE is highly variable and influenced by many factors, phase I and II trials reported rates from 10% to 80% for any grade irAE while an irAE of grade 3 or higher was observed in 2.5% to 18% of subjects. Despite the fact that older adults represent the growing majority of patients diagnosed with cancer, the efficacy and toxicity of ICI in older patients, alone or in combination with other agents, remains controversial. Presently, the specific immune mechanism(s) driving irAE are unknown and biomarkers that predict their onset, particularly high-grade irAE, are urgently needed. The identification of predictive clinical, laboratory and immunological biomarkers (blood and tissue) for toxicity will more accurately identify and quantify patients who are at risk for ICI therapy. Then, this will possibly allow better irAE management.

Study Type

Interventional

Enrollment (Anticipated)

441

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Anderlecht
      • Brussel, Anderlecht, Belgium, 1070
        • Recruiting
        • Institut Jules Bordet
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1) Age ≥ 18 years old
  • 2) ECOG performance status ≤ 1
  • 3) Must have histologically or cytologically confirmed solid tumour, eligible for treatment with ICI as standard-of-care alone or in combination with another ICI (cohort 1), ICI with chemotherapy (cohort 2), or ICI with targeted therapy (cohort 3) with no restrictions on number of prior systemic therapies
  • 4) All prior anti-cancer treatment-related toxicities (except alopecia) must be ≤ Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 at the time of enrolment
  • 5) Serum pregnancy test (for subjects of childbearing potential) negative within 15 days prior to study medications administration.
  • 6) Women of childbearing potential must agree to use one highly effective method of contraception prior study entry, during the course of the study and at least 7 months after the last administration of study treatments.
  • 7) Men with childbearing potential partner must agree to use condom during the course of this study and for at least 6 months after the last administration of the study treatments.
  • 8) Completion of all necessary screening procedures within 14 days prior to enrolment.
  • 9) Signed Informed Consent form (ICF) obtained prior to any study related procedure.

Exclusion Criteria:

  • Subjects meeting one of the following criteria are not eligible for this study:

    1. Subject 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.
    2. Participation in another clinical trial.
    3. Pregnant and/or lactating women.
    4. Subjects already receiving ICI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modification(s) in the immune blood markers of treated subjects on treatment.
Time Frame: Assessment: between week 4 and 6 after the first dose of the treatment
Modification(s) in the immune blood markers including cytokines, immune cells and serum autoantibody level of treated subjects.
Assessment: between week 4 and 6 after the first dose of the treatment
Modification(s) in the immune blood markers of treated subjects on treatment.
Time Frame: Assessment: between week 8 and 11 after the first dose of the treatment
Modification(s) in the immune blood markers including cytokines, immune cells and serum autoantibody level of treated subjects.
Assessment: between week 8 and 11 after the first dose of the treatment
Modification(s) in the immune blood markers of treated subjects on treatment.
Time Frame: Assessment: between week 13-18 after the first dose of the treatment
Modification(s) in the immune blood markers including cytokines, immune cells and serum autoantibody level of treated subjects.
Assessment: between week 13-18 after the first dose of the treatment
Modification(s) in the immune blood markers of treated subjects on treatment at the occurence of any grade 1 or 2 irAE.
Time Frame: Assessment: Day1 after diagnostic of any grade 1 or 2 irAE
Safety will be assessed and graded by the investigator(s) by using the adverse events reported during the study in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Assessment: Day1 after diagnostic of any grade 1 or 2 irAE
Modification(s) in the immune blood markers of treated subjects on treatment at the occurence of any grade 3 or 4 irAE.
Time Frame: Assessment: Day one after diagnostic of any grade 3 or 4 irAE
Safety will be assessed and graded by the investigator(s) by using the adverse events reported during the study in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Assessment: Day one after diagnostic of any grade 3 or 4 irAE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jules Bordet Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2022

Primary Completion (ANTICIPATED)

June 1, 2024

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

April 24, 2022

First Submitted That Met QC Criteria

June 22, 2022

First Posted (ACTUAL)

June 23, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 6, 2022

Last Update Submitted That Met QC Criteria

July 1, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IJB-IRAES-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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