Autoimmunity After Checkpoint Blockade

Last updated: February 24, 2025
Sponsor: University of Pennsylvania
Overall Status: Active - Recruiting

Phase

N/A

Condition

Autoimmune Disease

Neoplasms

Collagen Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT04119713
832823
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to better understand how the treatment of cancer with immune checkpoint inhibitors (ICI) leads to the development of autoimmunity. Specifically, we wish to understand the genetics and immune system features that cause a subset of cancer patients treated with checkpoint inhibitor therapy to develop an immune-related adverse event (irAE).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A diagnosis of cancer and prescription for a checkpoint inhibitor

Exclusion

Exclusion Criteria:

  • Any subjects not willing or able to give consent

  • Children under the age of 18

  • A history of transplant

Study Design

Total Participants: 300
Study Start date:
February 24, 2020
Estimated Completion Date:
June 30, 2026

Study Description

The goal of this study is to understand how the treatment of cancer with checkpoint inhibitors leads to the development of autoimmunity. Specifically, to understand the genetics and immune system features that cause a subset of cancer patients treated with checkpoint inhibitors to develop autoimmunity. At least 300 patients will be enrolled when they are initially prescribed any checkpoint inhibitor. Peripheral blood and serum from patients when they enroll and examine the genetics, serum factors, and phenotype of the immune system. There is no planned intervention. Subjects will be asked to provide peripheral blood and serum at established time points when they are getting therapeutic infusions and routine clinical labs, as well as, at the time they develop any autoimmune symptoms. Urine may also be collected at the time of enrollment, standard study visits, and/or at the time of an autoimmune complication. Inclusion criteria include a diagnosis of cancer, prescription for a checkpoint inhibitor, and fluency in English. Exclusion criteria include any subjects not willing or able to give consent, children under the age of 18, and history of transplant. There will not be any interventions. Clinical data will be extracted from electronic medical records. Coded data will be stored in a REDCap database. PHI and study key stored at UPenn on a password-protected database on an encrypted drive that is institutionally secured and managed by the University of Pennsylvania.

Connect with a study center

  • University of Pennsylvania - Abramson Cancer Center

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.