An observational study in Immune-related Adverse Event, sponsored by University of Chicago. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by University of Chicago · Observational
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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.
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 diseases affecting multiple organ systems, including the skin, gastrointestinal tract, liver, lung, and nervous system.
Therapeutic plasma exchange is an established therapeutic procedure in selected immune-mediated diseases where rapid removal of circulating pathogenic material is clinically relevant (13). In these settings, TPE/PLEX can remove circulating antibodies, immune complexes, complement-related factors, inflammatory mediators, and therapeutic monoclonal antibodies. These precedents support the biologic rationale for considering TPE/PLEX in selected severe irAEs when treating clinicians believe that removal of circulating ICI and/or soluble immune mediators may be clinically appropriate. Immune-related adverse events are an acceptable indication for TPE/PLEX, and the procedure may be considered based on individual patient circumstances and treating-team judgment. The purpose of this small, single-arm, open-label Phase 1 pharmacokinetic study is to characterize ICI concentrations during and after TPE in patients with severe irAEs.
Timed PK blood samples will be collected during and after TPE/PLEX according to the study PK sampling plan. Clinically relevant information will be collected from participant's medical record throughout the study.
University of Chicago is the lead sponsor of 924 studies on the registry; 186 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
The subject population consists of people who have a planned or is currently undergoing a TPE procedure at the University of Chicago Medicine.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with severe immune-related adverse events (irAEs) from immune checkpoint inhibitors (ICIs) who will received therapeutic plasma exchange (TPE; performed using FDA-cleared apheresis devices (Spectra Optia Apheresis System)) as part of their standard-of-care.
Device: Spectra Optia Apheresis System
Therapeutic plasma exchange (using the Spectra Optia Apheresis System) will be done according to standard of care.
This study also gives Pembrolizumab, Nivolumab, Ipilimumab. No intervention listed here names it: that was found by reading the record.
Change in circulating ICI concentration during and after TPE/PLEX
This will be measured by ICI concentration before and after TPE/PLEX sessions when paired samples are available, Percent change in ICI concentration from pre- to post-TPE/PLEX, and ICI concentration-time profiles across available PK sampling time points
Time frame: Baseline to Day 90
Assess the feasibility of conducting a small PK-focused Phase 1 study of TPE/PLEX in patients with severe irAEs.
This will be measured by the Proportion of eligible patients successfully identified and approached, approached patients who consent to study participation, enrolled patients who undergo at least one TPE/PLEX session, enrolled patients with at least one evaluable PK sample, enrolled patients with paired pre-/post-TPE/PLEX PK samples
Time frame: Baseline to Day 90
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
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This study is withdrawn, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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