Phase 1/2 Trial to determine the safety and efficacy of Extracorporeal photopheresis as treatment for steroid-refractory immune related adverse events after immune checkpoint inhibitor therapy - ECIR (ECP for irAE)

Medical Center - University of Freiburg0 sites30 target enrollmentFebruary 10, 2022

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Immune related adverse events induced by treatment with immune checkpoint inhibitors (monoclocanl antibodies against PD-1, PD-L1 or CTLA-4)
Sponsor: Medical Center - University of Freiburg
Enrollment: 30
Status: Active, not recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

February 10, 2022

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Medical Center - University of Freiburg

•1\.Male and female patients aged \=18 years with adequate German written and oral language skills
•2\.Written informed consent:
•Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines.
•Subjects must be able to understand and willing to comply with scheduled visits, treatment schedule, laboratory tests and mandatory collection of blood, and other requirements of the study.
•Subject Re\-enrollment: This trial permits the re\-enrollment of a subject that has discontinued the study as a screening failure. If re\-enrolled, the subject must be re\-consented.
•3\.Target population
•Patients who have received treatment with an anti\-PD\-1, anti\-PD\-L1 or an anti\-CTLA\-4 antibody or any combination of these for any type of malignancy in the last 24 months before screening. 30% of the patients that will be included should have non\-skin cancer.
•Patients should have clinical and/or histological evidence of immune\-related adverse events as follows:
•?Diarrhea with increase of \=4 stools over baseline
•?No improvement after 72h treatment with at least 1 mg/kg BW/day prednisolone equivalent

•1\.Active treatment in a clinical study of any investigational agent within 14 days prior day 0 or within 5 half\-lives of the study treatment, whichever is greater.
•2\.Positive result for HIV.
•3\.Active COVID\-19\-infection or non\-compliance with the prevailing hygiene measures regarding the COVID\-19 pandemic
•4\.Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
•5\.Patients who require vasopressors, and/or have NYHA class III or IV heart failure.
•6\.Uncontrolled hypertension or ventricular arrhythmias.
•7\.Previous or concurrent malignancies within the last 3 years of enrollment other than the disease for which checkpoint\-inhibitor blockade was applied. Exceptions are adequately treated basal or squamous cell skin cancer, or any other cancer from which the subject has been disease\-free for more than 3 years.
•8\.Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data
•9\.Known allergies, hypersensitivity, or intolerance of methoxypsoralen, excipients, or similar compounds, acid\-citrate\-dextrose or similar compounds
•10\.Aphakia