DRKS00025078
Completed
Phase 1
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)
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
- niversitätsklinikum Freiburg
- Enrollment
- 14
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •Patients should have clinical and/or histological evidence of immunerelated 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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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