Immunological Variables Associated to ICI Toxicity in Cancer Patients

NCT05429866 | Unknown Phase 2

• 1 other identifier: IJB-IRAES-2020
• Study Type: interventional
• Target: 441
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Melanoma; Non Small Cell Lung Cancer; Non-melanoma Skin Cancer; Gastrointestinal Cancer; Head and Neck Cancer; Renal Cell Carcinoma; Small Cell Lung Cancer; Mesothelioma, Malignant; Bladder Cancer; Merkel Cell Carcinoma; Hepatocellular Carcinoma; MSI-H Colorectal Cancer

Outcome Measures

Primary Outcomes (5)

• Modification(s) in the immune blood markers of treated subjects on 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.

  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.

  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.

  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.

  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

Interventions

Checkpoint Blockade, Immune DRUG

Immune checkpoint blockade drugs target the immune system by blocking control pathways regulating anti-tumor immunity and thereby reinvigorate their activities against cancer.

Also known as: Ipililumab, Nivolumab, Pembrozilumab, atezolizumab, avelumab, durvalumab, Cemiplimab

Eligibility Criteria

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

You may qualify if:

• \) Age ≥ 18 years old
• \) ECOG performance status ≤ 1
• \) 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
• \) 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
• \) Serum pregnancy test (for subjects of childbearing potential) negative within 15 days prior to study medications administration.
• \) 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.
• \) 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.
• \) Completion of all necessary screening procedures within 14 days prior to enrolment.
• \) Signed Informed Consent form (ICF) obtained prior to any study related procedure.

You may not qualify if:

• Subjects meeting one of the following criteria are not eligible for this study:
• 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.
• Participation in another clinical trial.
• Pregnant and/or lactating women.
• Subjects already receiving ICI.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Institut Jules Bordet

Brussels, Anderlecht, 1070, Belgium

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Melanoma; Carcinoma, Non-Small-Cell Lung; Gastrointestinal Neoplasms; Head and Neck Neoplasms; Carcinoma, Renal Cell; Small Cell Lung Carcinoma; Mesothelioma, Malignant; Urinary Bladder Neoplasms; Carcinoma, Merkel Cell; Carcinoma, Hepatocellular

Interventions

Immune Checkpoint Inhibitors; Nivolumab; atezolizumab; avelumab; durvalumab; cemiplimab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Mesothelioma; Adenoma; Neoplasms, Mesothelial; Pleural Neoplasms; Urinary Bladder Diseases; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Liver Neoplasms; Liver Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

mireille Langouo Fontsa, MD

CONTACT

0032 (0) 484729928; mireille.langouo@bordet.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: June 23, 2022
• Study Start: September 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)