A Phase 1 Pharmacokinetic Study of Therapeutic Plasma Exchange for Severe Immune-Related Adverse Events From Immune Checkpoint Inhibitors
University of Chicago
Summary
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.
Description
Immune checkpoint inhibitors (ICIs) have revolutionized cancer therapy across multiple tumor types; however, their mechanism of action-releasing immune inhibition-inevitably predisposes patients to immune-related adverse events (irAEs). These toxicities occur in up to 74% of patients treated with PD-(L)1 inhibitors and in more than 90% of those receiving combination therapy, with grade 3-5 events in 14-55% of cases depending on regimen and tumor type. Immune-related adverse events caused by ICIs often present with a spectrum of clinical manifestations that closely resemble primary autoimmune d…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Suspected or con…
Interventions
- DeviceSpectra Optia Apheresis System
Therapeutic plasma exchange (using the Spectra Optia Apheresis System) will be done according to standard of care.
Location
- The University of ChicagoChicago, Illinois