ECP for Immune-related Adverse Events After Checkpoint Inhibitor Treatment (NCT05414552) | Clinical Trial Compass
CompletedNot Applicable
ECP for Immune-related Adverse Events After Checkpoint Inhibitor Treatment
Germany11 participantsStarted 2021-06-01
Plain-language summary
Preliminary data demonstrate that irAEs induced by immune checkpoint blockade can be successfully treated with ECP (Apostolova et al. NEJM 2020). Therefore this retrospective analysis is launched to validate the finding made with the individual patient in a larger patient cohort. The analysis will include the evaluation of safety of ECP treatment in patients with irAEs and collect data on the efficacy of ECP as a treatment for immune-related adverse events and its effect on tumor progression.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male and female patients aged ≥18 years
✓. Written informed consent:
✓. Target population
✓. Maximum of one additional (second line) therapy after Steroid treatment before ECP starts (e.g. infliximab for colitis)
✓. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 1 week prior to the start of study drug.
✓. Women must not be breastfeeding.
✓. ECOG performance status 0, 1, or 2
Exclusion criteria
✕. 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.
✕. Positive result for HIV.
✕. Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
✕. Mechanical ventilation or patients who have resting O2 saturation \<90% by pulse-oximetry.
✕. Patients who require vasopressors, and/or have NYHA class III or IV heart failure.
✕. Uncontrolled hypertension or ventricular arrhythmias.
What they're measuring
1
Safety - treatment-related adverse events (AEs) and severe adverse events (SAEs)
✕. 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.
✕. 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