Immune-related Adverse EventPRIANCT05700565
Treatment of Immune-related Adverse Events Refractory to Standard Therapy and Associated Changes in Immunophenotype
An observational study of Immune-related Adverse Event, run by Lucie Heinzerling at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Immune-related Adverse Event
- What is being tested?
- Extracorporeal photopheresis and Other immunosuppressive or immunomodulatory drugs
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2022to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- Subjects must we willing and able to comply with scheduled visits and must have given written informed consent.
- irAE after immune checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA4 blockade)
- 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.
Who cannot join
- 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
- Pregnancy
- Body weight less than 40 kg.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Immune-related Adverse Event
- Being tested
- Extracorporeal photopheresis, Other immunosuppressive or immunomodulatory drugs
- Keywords
- Steroid-refractory, Steroid-dependent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal photopheresisOther
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 immunosuppressive or immunomodulatory drugsOther
Other immunosuppressive or immunomodulatory drugs
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Extracorporeal photopheresis; Other: Other immunosuppressive or immunomodulatory drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunophenotype
Characterisation of peripheral mononuclear blood cells
Measured: 12 weeks
Secondary outcomes (2)
Developement of grade of irAE
irAE symptoms graded according to CTCAE v5.0
Measured: 12 weeks
Patient quality of life
Quality of life assessed by EORTC QLQ-C30
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Jan 2022
- Primary completion1 Jun 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Immune-related Adverse EventStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lucie Heinzerling
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lucie Heinzerling, LMU Klinikum
- Investigators
- Lucie Heinzerling, Principal investigator, Department of Dermatology and Allergy, University Hospital, LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700565
- Sponsor's protocol ID
- LMUKlinikum
- Acronym
- PRIA
- Status last verified
- Jun 2026
- First submitted
- 4 Nov 2022
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wein L, Ertl C, Ruf T, Morak M, Wang Y, Schmitt C, Garza Vazquez X, Glatzel V, David-Rus R, Mitwalli M, Srour J, Schopf P, Tomsitz D, French LE, Heinzerling L. Extracorporeal photopheresis versus systemic immunosuppression for treatment of immune-related adverse events: clinical outcomes from the prospective two-arm PRIA study. J Immunother Cancer. 2026 Jun 12;14(6):e015185. doi: 10.1136/jitc-2026-015185.
PubMed 42285609Ertl C, Ruf T, Hammann L, Piseddu I, Wang Y, Schmitt C, Garza Vazquez X, Kabakci C, Bonczkowitz P, de Toni EN, David-Rus R, Srour J, Tomsitz D, French LE, Heinzerling L. Extracorporeal photopheresis vs. systemic immunosuppression for immune-related adverse events: Interim analysis of a prospective two-arm study. Eur J Cancer. 2024 Nov;212:115049. doi: 10.1016/j.ejca.2024.115049. Epub 2024 Sep 27.
PubMed 39383612
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Immune-related Adverse Events Refractory to Standard Therapy and Associated Changes in Immunophenotype
- ClinicalTrials.gov ID
- NCT05700565
- Acronym / sponsor ID
- PRIA / LMUKlinikum
- Conditions
- Immune-related Adverse Event
- Keywords
- Steroid-refractory, Steroid-dependent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Lucie HeinzerlingUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Steroid-refractory or dependent immune-related adverse events | – | Other: Extracorporeal photopheresis, Other: Other immunosuppressive or immunomodulatory drugsImmune-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 |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Subjects must we willing and able to comply with scheduled visits and must have given written informed consent.
- irAE after immune checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA4 blockade)
- 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.
Key exclusion criteria (3 listed)
- 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
- Pregnancy
- Body weight less than 40 kg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal photopheresisECP 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 | Steroid-refractory or dependent immune-related adverse events |
| Other immunosuppressive or immunomodulatory drugsOther immunosuppressive or immunomodulatory drugs | Other | Steroid-refractory or dependent immune-related adverse events |
Primary outcome
Immunophenotype
Time frame: 12 weeks
Characterisation of peripheral mononuclear blood cells
2 secondary outcomes
Developement of grade of irAE
Time frame: 12 weeks
Patient quality of life
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Derived from this study: PubMed 42285609Wein L, Ertl C, Ruf T, Morak M, Wang Y, Schmitt C, Garza Vazquez X, Glatzel V, David-Rus R, Mitwalli M, Srour J, Schopf P, Tomsitz D, French LE, Heinzerling L. Extracorporeal photopheresis versus systemic immunosuppression for treatment of immune-related adverse events: clinical outcomes from the prospective two-arm PRIA study. J Immunother Cancer. 2026 Jun 12;14(6):e015185. doi: 10.1136/jitc-2026-015185.
- Derived from this study: PubMed 39383612Ertl C, Ruf T, Hammann L, Piseddu I, Wang Y, Schmitt C, Garza Vazquez X, Kabakci C, Bonczkowitz P, de Toni EN, David-Rus R, Srour J, Tomsitz D, French LE, Heinzerling L. Extracorporeal photopheresis vs. systemic immunosuppression for immune-related adverse events: Interim analysis of a prospective two-arm study. Eur J Cancer. 2024 Nov;212:115049. doi: 10.1016/j.ejca.2024.115049. Epub 2024 Sep 27.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucie Heinzerling principal investigator
Department of Dermatology and Allergy, University Hospital, LMU Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune-related Adverse Event, run by Lucie Heinzerling at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunophenotype (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05700565, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.