Autoimmunity After Checkpoint Blockade

Cancer Clinical Trial

Official title:

Mechanisms of Immunotoxicology in Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04119713
• Other study ID #: 832823
• Status: Recruiting
• Start date: February 24, 2020
• Est. completion date: June 30, 2026

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: Kyra J Sacksith
• Phone: 215-898-9339
• Email: kyra.sacksith[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Autoimmunity
• Cancer
• Immunotoxicity
• Oncology

Locations

Country	Name	City	State
United States	University of Pennsylvania - Abramson Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	3 years
Primary	The prevalence of immune-related adverse events (irAEs) that complicate checkpoint inhibitor therapy.	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.	3 years
Secondary	The number of future research studies and/or collaborations resulting directly from the databank of tissues and other relevant clinical information that will be established.	To facilitate collaborations between research groups from diverse disciplines that enables rapid translation of ongoing and future basic research findings that leads to individualized, or personalized care for patients receiving immunotherapies.	3 years