NCT05429866

Immunological Variables Associated to ICI Toxicity in Cancer Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 441 (estimated)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

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

Interventions

Type	Name	Description
DRUG	Checkpoint Blockade, Immune	Immune checkpoint blockade drugs target the immune system by blocking control pathways regulating anti-tumor immunity and thereby reinvigorate their activities against cancer.

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2022-06-23
• Last updated: 2023-03-08

Locations

1 site across 1 country: Belgium