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Understanding Autoimmunity After Checkpoint Inhibitor Therapy

This study aims to understand why some cancer patients treated with checkpoint inhibitors develop autoimmune conditions. Checkpoint inhibitors are a type of cancer treatment that helps your immune system fight cancer. Researchers want to learn about the genetic and immune system factors that lead to these immune-related side effects (irAEs). You can join if you have cancer and are prescribed a checkpoint inhibitor, are at least 18 years old, and can give consent. The study will look at your blood cells and the prevalence of irAEs over 6 years to better understand these reactions.

Study design
This is an observational study with a planned enrollment of 600 participants. It will examine patients receiving checkpoint inhibitor therapy.
What's involved
You will be asked to provide blood and serum samples at established time points during your therapeutic infusions and routine clinical labs. Urine samples may also be collected at enrollment and during study visits or if you develop autoimmune symptoms.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 years to measure the characteristics of their blood cells and the prevalence of immune-related adverse events.

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NCT04119713

Autoimmunity After Checkpoint Blockade

Recruiting
Not specifiedAges 18+Observational
Abramson Cancer Center at Penn Medicine
~600 participants
Updated 2026-01-08 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The phenotype and function of peripheral blood cells (i.e., CD4+ T cells, CD8+ T cells, B cells, myeloid cells) characteristic to patients receiving checkpoint inhibitor therapy.
Measured over 6 years
+1 more outcome measured

Conditions

Autoimmunity
Cancer
Immunotoxicity
Oncology

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Malignant Neoplasm

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Sokratis Apostolidis, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

Who to contact

Kyra J Sacksith
[email protected]
215-898-9339
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

A diagnosis of cancer and prescription for a checkpoint inhibitor

Exclusion

Any subjects not willing or able to give consent
Children under the age of 18
A history of transplant

What this trial measures

  • The phenotype and function of peripheral blood cells (i.e., CD4+ T cells, CD8+ T cells, B cells, myeloid cells) characteristic to patients receiving checkpoint inhibitor therapy.6 years

    The phenotypic analysis will include multiple surface markers that define populations of cells, including activated, memory, and regulatory populations. Cells will also be activated to determine which cytokines are produced.

  • The prevalence of immune-related adverse events (irAEs) that complicate checkpoint inhibitor therapy.6 years

    This is a pilot analysis to better understand how the treatment of cancer with immune checkpoint inhibitors leads to the development of autoimmunity in a subset of cancer patients.