Evidence map›Paper›PMID 42919851›Full record

Trial reportNature communications2026

Extracorporeal photopheresis for the treatment of steroid-refractory immune related adverse events from immune checkpoint inhibitor therapy: a multi-center phase Ib/II clinical trial.

Roxane Riemer, Lukas M Braun, Sophie Giesler, David Rafei-Shamsabadi, Sebastian Haferkamp, Alina Hartmann, Wolfgang Melchinger, Matthias Weiss, Stefanie Birth, Ulrike Philipp and 36 more

Abstract readMulticenter StudyClinical Trial, Phase IIClinical Trial, Phase I
PubMed Publisher
In one paragraph

Trial report in Nature communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

46 authors.

Roxane Riemer *Department of Internal Medicine I, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Lukas M Braun *Department of Internal Medicine I, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.ORCID http://orcid.org/0000-0003-0770-4994
Sophie GieslerDepartment of BioMedical Research, Tumor Immunology, University of Bern, Bern, Switzerland.ORCID http://orcid.org/0000-0002-8146-2199
David Rafei-ShamsabadiDepartment of Dermatology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.ORCID http://orcid.org/0000-0002-7850-3199
Sebastian HaferkampDepartment of Dermatology, University Hospital Regensburg, Regensburg, Germany.
Alina HartmannDepartment of Internal Medicine I, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Wolfgang MelchingerDepartment of Internal Medicine I, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Matthias WeissDepartment of Internal Medicine I, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Stefanie BirthDepartment of Internal Medicine I, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Ulrike PhilippDepartment of Internal Medicine I, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Inga GebhardDepartment of Internal Medicine I, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Carsten SchwänenDivision of Hematology, Oncology, Palliative Care, Ortenau Hospital Offenburg-Kehl, Offenburg, Germany.
James A HutchinsonDepartment of Surgery, University Hospital Regensburg, Regensburg, Germany.ORCID http://orcid.org/0000-0002-1199-4210
Nikolaos KarantzelisDepartment of Medical Oncology and Hematology, University Hospital of Zurich, Zurich, Switzerland.
Till WallrabensteinCenter for Hematology and Oncology, Kantonspital Baselland, Bruderholz, Switzerland.ORCID http://orcid.org/0000-0002-6672-3135
Theresa LowinusDepartment of Internal Medicine I, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Niklas BrehmDepartment of Internal Medicine I, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Justyna RawlukDepartment of Internal Medicine I, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Dietmar PfeiferDepartment of Internal Medicine I, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Natascha OsswaldDepartment of Internal Medicine I, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.ORCID http://orcid.org/0009-0003-8095-5287
Peter BronsertInstitute of Surgical Pathology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.ORCID http://orcid.org/0000-0001-8558-0347
Manuel RoggInstitute of Surgical Pathology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.ORCID http://orcid.org/0000-0002-6658-9159
Grigor AndreevInstitute of Surgical Pathology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.ORCID http://orcid.org/0009-0008-3808-8331
Melanie BoerriesGerman Cancer Consortium (DKTK), Partner site Freiburg, a partnership between DKFZ and Medical Center-University of Freiburg, Freiburg, Germany.ORCID http://orcid.org/0000-0002-3670-0602
Maximilian LammerDepartment of Dermatology, Venereology and Allergy, Medical University Innsbruck, Innsbruck, Austria.ORCID http://orcid.org/0009-0002-7306-5457
Van Anh NguyenDepartment of Dermatology, Venereology and Allergy, Medical University Innsbruck, Innsbruck, Austria.
Matthias SchmuthDepartment of Dermatology, Venereology and Allergy, Medical University Innsbruck, Innsbruck, Austria.
Natalie KöhlerDepartment of Internal Medicine I, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.ORCID http://orcid.org/0000-0002-7502-0431
Justus DuysterDepartment of Internal Medicine I, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.ORCID http://orcid.org/0000-0001-7325-7753
Gabriele IhorstClinical Trials Unit, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.ORCID http://orcid.org/0000-0002-8091-1589
Philip KeyeEye Center, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.ORCID http://orcid.org/0000-0001-8307-5267
Susana MinguetSignalling Research Centres BIOSS and CIBSS, Freiburg, Germany.ORCID http://orcid.org/0000-0001-8211-5538
Dirk SchadendorfDepartment of Dermatology, University Hospital Essen, University of Duisburg-Essen, Essen, and German Cancer Consortium (DKTK), Partner Site Essen/Duesseldorf, Essen, Germany.ORCID http://orcid.org/0000-0003-3524-7858
Selma UgurelKlinikum Bielefeld Rosenhöhe, Department of Dermatology, Medical School and University Medical Center OWL, Bielefeld University, Bielefeld, Germany.ORCID http://orcid.org/0000-0002-9384-6704
Robert ThimmeDepartment of Internal Medicine II (Gastroenterology, Hepatology, Endocrinology and Infectious Diseases), Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.ORCID http://orcid.org/0000-0003-1417-4135
Peter HasselblattDepartment of Internal Medicine II (Gastroenterology, Hepatology, Endocrinology and Infectious Diseases), Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Erika L PearceThe Bloomberg-Kimmel Institute for Cancer Immunotherapy, Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.ORCID http://orcid.org/0000-0001-5592-5439
Burkhard BecherInstitute of Experimental Immunology, University of Zurich, Zurich, Switzerland.ORCID http://orcid.org/0000-0002-1541-7867
Carolin Funke-LorenzDepartment of Dermatology, University Hospital Essen, University of Duisburg-Essen, Essen, and German Cancer Consortium (DKTK), Partner Site Essen/Duesseldorf, Essen, Germany.
Florian SchererDepartment of Internal Medicine I, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.ORCID http://orcid.org/0000-0001-9635-5487
Bertram BengschGerman Cancer Consortium (DKTK), Partner site Freiburg, a partnership between DKFZ and Medical Center-University of Freiburg, Freiburg, Germany.ORCID http://orcid.org/0000-0003-2552-740X
Christoph SchellInstitute of Surgical Pathology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Jan-Malte PlackeDepartment of Dermatology, University Hospital Essen, University of Duisburg-Essen, Essen, and German Cancer Consortium (DKTK), Partner Site Essen/Duesseldorf, Essen, Germany.
Frank MeissDepartment of Dermatology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.ORCID http://orcid.org/0000-0002-4044-9094
Petya ApostolovaDepartment of Internal Medicine I, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.ORCID http://orcid.org/0000-0002-3856-5109
Robert ZeiserDepartment of Internal Medicine I, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. robert.zeiser@uniklinik-freiburg.de.ORCID http://orcid.org/0000-0001-6565-3393

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Severe immune-related adverse events (irAE) in cancer patients receiving immune checkpoint inhibitors (ICI) require treatment interruption and immunosuppression. Based on prior preclinical data, in this prospective, single arm, non-randomized phase-Ib/II clinical trial we test the activity of Extracorporeal Photopheresis (ECP) against steroid-refractory irAEs in 30 patients (EudraCT-No.:2021-002073-26). The primary endpoint is the evaluation of the safety of ECP treatment for patients with ICI-induced irAEs. The study meets its pre-specified primary endpoint of less than 50% of patients developing ECP-related severe adverse events (SAE). No ECP-related SAE is observed and ECP-related AEs are reported in 20% (6/30) of patients. Overall response rate for all irAEs is 96.3% (CI 81.0-99.91). Colitis-, hepatitis- and dermatitis-specific response rates are 100% (13/13), 86.7% (13/15) and 100% (3/3), respectively. Secondary endpoints include the assessment of response rate of irAE and overall survival. ECP therapy is associated with reduced granzyme-A/B/K, T-bet, interferon-γ and TNF in peripheral T cells and pro-inflammatory gene-expression in the intestinal tract. The 12-month overall survival rate is 84.3% (CI 63.4%-93.8%). Response correlates with a decrease in inflammatory gene expression in the intestinal tract. These results suggest that ECP is a safe treatment option for SR-irAEs and warrant further investigation in subsequent randomized clinical trials.

Indexed as

Immune Checkpoint InhibitorsNeoplasmsPhotopheresisAdultAgedColitisFemaleHumansMaleMiddle AgedProspective StudiesSteroidsTreatment OutcomeImmune Checkpoint InhibitorsSteroids

Identifiers

PMID42919851

What OpenQuestion holds

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.