UPCC 11519 Mechanisms of Immunotoxicology in Cancer Patients

Investigating Immune System Reactions in Cancer Patients Using Investigational Medications

Enrolling By Invitation
18 years or above
All
Phase N/A
600 participants needed
1 Location

Brief description of study

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).

Detailed description of study

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. Protected health information (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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Autoimmunity, Cancer, Immunotoxicity, Oncology
  • Age: 18 years or above
  • Gender: All

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

This study investigates how cancer treatment with immune checkpoint inhibitors (ICI) can lead to the development of autoimmunity. The purpose is to understand the genetic and immune system characteristics that cause some cancer patients to experience immune-related adverse events (irAE) after receiving checkpoint inhibitor therapy.

Participants will provide peripheral blood and serum samples at various times, such as during therapeutic infusions and routine clinical labs, as well as if they develop autoimmune symptoms. Urine samples may also be collected at enrollment and during study visits. This study does not involve any interventions, and clinical data will be collected from electronic medical records.

  • Who can participate: Adults with a cancer diagnosis who are prescribed a checkpoint inhibitor and are fluent in English can participate. Individuals unwilling or unable to give consent, children under 18, and those with a history of transplant are excluded.
  • Study details: Participants will provide blood and serum samples at specific times, with no interventions involved. Clinical data will be collected from medical records and stored securely.
Updated on 08 Jan 2026. Study ID: 19-0255
If you need assistance finding a non-cancer clinical research study or if you have any questions, please email psom-ocr@pobox.upenn.edu For Cancer trials contact Penn Medicine's Cancer Trial Navigator at: PMCancerResearch@pennmedicine.upenn.edu or 215-349-8245

Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

Contact Abramson Cancer Center Navigator