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Treatment of Immune-related Adverse Events Refractory to Standard Therapy and Associated Changes in Immunophenotype — PRIA  

Immune-related Adverse Event Clinical Trial

Official title:
Treatment of Immune-related Adverse Events Refractory to Standard Therapy and Associated Changes in Immunophenotype

Clinical Trial Summary

This study is an open, monocentric study. It includes patients with irAE refractory to standard therapy or patients where corticosteroids cannot be tapered. Patients will either be treated with ECP or second line immunosuppressive therapy according to investigator's choice. Patients will be followed for 24 weeks after first treatment.

Clinical Trial Description

At inclusion patient history including type of tumor and immunotherapy will be obtained. At all visits symptoms, changes in concomitant medication, a medical assessment and laboratory investigations will be performed. Blood sampling for safety analysis and for investigating the immunophenotype will be performed at baseline, week 1, 4, 8 and 12. Laboratory values assessed include: - Complete blood count - Chemistry including liver enzymes (AST, ALT) and total bilirubin in the case of immune-related hepatitis, CK in case of myositis, creatinine in case of nephritis - Inflammatory markers: CRP, IL-6, Procalcitonin Peripheral blood mononuclear cells (PBMC) will be used to determine immunophenotype, including the amount of NK-cells, regulatory T- cells and myeloid-derived suppressor cells (MDSC) as well as the expression of inflammatory markers. Biological samples will be frozen for later analysis. Additionally, patients will assess their symptoms and their quality of life by a self-administered questionnaire at baseline and week 4, 8 and 12. Quality of life will be assessed by EORTC QLQ-C30. All irAE will be graded according to CTCAE. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05700565
Study type Observational
Source LMU Klinikum
Contact Lucie Heinzerling
Phone +49 89 4400 56326
Email lucie.heinzerling@med.uni-muenchen.de
Status Recruiting
Phase
Start date January 1, 2022
Completion date January 1, 2027
View Details
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