Who is eligible for clinical trial NCT07756242?

Participants must meet protocol criteria for Immune-related Adverse Event. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07756242 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-05

Pharmacokinetic Study of Therapeutic Plasma Exchange (NCT07756242)

🟡 Not Yet Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: University of Chicago

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (6 items).

Location: The University of Chicago — Chicago, Illinois

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

The University of Chicago — Chicago, Illinois

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗