Recruiting

Autoimmunity

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT04119713

Conditions

Autoimmunity

Cancer

Immunotoxicity

Oncology

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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).

Conditions

Autoimmunity

Cancer

Immunotoxicity

Oncology

Study ID

NCT04119713

Start date

Feb 24, 2020

Status verified date

Jan, 2026

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • A diagnosis of cancer and prescription for a checkpoint inhibitor

Exclusion Criteria:

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

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

Study Population

Adult patients with a diagnosis of cancer receiving checkpoint inhibitor therapy at the University of Pennsylvania's Abramson Cancer Center (ACC).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kyra J Sacksith

215-898-9339kyra.sacksith@pennmedicine.upenn.edu

Locations

University of Pennsylvania - Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-01-08.