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

September 3, 2026 updated by: Lucie Heinzerling
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Observational

Enrollment (Actual)

46

Contacts and Locations

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

Study Locations

  • Germany
      • Munich, Germany, 80337
        • LMU Klinikum Hauttumorzentrum

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with irAE after immune checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA4 blockade) refractory to therapy with corticosteroids or inability to taper corticosteroids to prednisone equivalent <= 5mg. An irAE is defined as refractory if corticosteroids do not improve symptoms within 72 hours. The inability to taper corticosteroids is defined as relapse on standard tapering of 1 mg/kg corticosteroid over 28 days.

Description

Inclusion Criteria:

  1. Subjects must we willing and able to comply with scheduled visits and must have given written informed consent.
  2. irAE after immune checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA4 blockade)
  3. irAE refractory to therapy with corticosteroids or inability to taper corticosteroids to prednisone equivalent <= 5mg. An irAE is defined as refractory if corticosteroids do not improve symptoms within 72 hours. The inability to taper corticosteroids is defined as relapse on standard tapering of 1 mg/kg corticosteroid over 28 days.

Exclusion Criteria:

  1. Contraindications for the treatment with ECP including a known sensitivity to psoralen compounds such as 8-MOP, comorbidities that may result in photosensitivity, aphakia, history of heparin-induced thrombocytopenia, unsatisfactory cardio-circulatory function, low hematocrit values
  2. Pregnancy
  3. Body weight less than 40 kg.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Steroid-refractory or dependent immune-related adverse events
Immune-related adverse events (irAE) after immune checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA4 blockade) refractory to therapy with corticosteroids or inability to taper corticosteroids to prednisone equivalent <= 5mg
Other: Extracorporeal photopheresis
ECP consists of the three steps of leukapheresis, photoactivation and reinfusion and has immunomodulatory effects (modulation of dendritic cells, change in cytokine profile, induction of T cell subpopulations). Indications are currently the treatment of Sézary syndrome, Graft-versus-host disease (GvHD), organ transplant rejection and systemic scleroderma.
Other: Other immunosuppressive or immunomodulatory drugs
Other immunosuppressive or immunomodulatory drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunophenotype
Time Frame: 12 weeks
Characterisation of peripheral mononuclear blood cells
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Developement of grade of irAE
Time Frame: 12 weeks
irAE symptoms graded according to CTCAE v5.0
12 weeks
Patient quality of life
Time Frame: 12 weeks
Quality of life assessed by EORTC QLQ-C30
12 weeks

Collaborators and Investigators

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

Sponsor

Lucie Heinzerling

Investigators

  • Principal Investigator: Lucie Heinzerling, Department of Dermatology and Allergy, University Hospital, LMU Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 1, 2022

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

October 1, 2025

Study Registration Dates

First Submitted

November 4, 2022

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMUKlinikum

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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