Pharmacokinetic Study of Therapeutic Plasma Exchange

Starting soon

Conditions studied: Immune-related Adverse Event

In brief

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.

Key facts

Study ID

NCT07756242

Run by

University of Chicago

People needed

15

Starts

2026-11-01

Expected to finish

2028-02-01

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 confirmed severe or clinically significant immune-related adverse event for which the treating clinical team considers TPE/PLEX clinically appropriate.
• Planned to undergo or currently undergoing TPE/PLEX at the University of Chicago Medicine.
• Approval from the patient's primary clinical service for study participation.
• Able to provide written informed consent, or has a legally authorized representative able to provide consent if permitted by the IRB-approved consent process.
• In the opinion of the treating team and study team, PK blood sample collection can be performed without delaying or interfering with clinically indicated care.

You may not qualify if…

• 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.
• Any condition that, in the opinion of the investigator or treating team, would make participation in the research procedures unsafe or inappropriate.

Where it is running

• The University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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