Pharmacokinetic Study of Therapeutic Plasma Exchange
ConditionImmune-related Adverse Event
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Chicago
About this trial
The purpose of this study is to characterize the pharmacokinetics of one or more ICIs during and after TPE/PLEX in patients with severe irAEs.
Eligibility criteria
Qualifiers
Adults ≥ 18 years of age
Diagnosis of any malignancy.
Receiving or recently received an immune checkpoint inhibitor, including anti-PD-1, anti-PD-L1, anti-CTLA-4, or combination ICI therapy. Eligible agents may include, but are not limited to, pembrolizumab, nivolumab, atezolizumab, durvalumab, avelumab, cemiplimab, dostarlimab, and ipilimumab.
Received an ICI within 12 weeks prior to planned enrollment, or within a timeframe considered appropriate by the PI for PK evaluation based on the specific ICI agent, dosing history, and assay feasibility.
Disqualifiers
No prior exposure to an immune checkpoint inhibitor.
TPE/PLEX is being performed for an indication unrelated to a suspected or confirmed ICI-associated immune-related adverse event.
Inability to provide informed consent and no legally authorized representative is available, if applicable.
PK blood sample collection is not feasible without delaying, altering, or interfering with clinically indicated care.
Trial design
Treatments tested in this trial
- Spectra Optia Apheresis System
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov