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Immunological Variables Associated to ICI Toxicity in Cancer Patients

NCT05429866 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 441

Last updated 2023-03-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Jules Bordet Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-06-01
Completion
2024-12-01

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05429866 on ClinicalTrials.gov