Autoimmunity After Checkpoint Blockade

NCT04119713 | Recruiting DMC

• 1 other identifier: 832823
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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.

  6 years

• 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.

  6 years

Secondary Outcomes (1)

• 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.

  6 years

Study Arms (1)

Study Population

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults who are able to consent to the study and are identified by their physician or a clinical coordinator to receive an immune checkpoint inhibitor for the treatment of cancer.

You may qualify if:

• A diagnosis of cancer and prescription for a checkpoint inhibitor

You may not qualify if:

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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

University of Pennsylvania - Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

50 mls of peripheral blood will be drawn at the time that patients are prescribed an immune checkpoint inhibitor (ICI) which will be banked for serum and PBMCs. No more than 50 mls of blood will be drawn at the following established points: at the time of the second drug infusion, at 6 months, at 12 months, and between 18 and 24 months. Additionally, no more than 50 mls of blood will be drawn at any time that a participant develops an autoimmune complication. An assessment tool that queries symptoms suggestive of a number of common immunotherapy-related adverse events (PRO-CTCAE) will be administered to consented patients at each visit in concert with the standard-of-care patient reported outcomes tool currently in use in Cancer Center clinics.

MeSH Terms

Conditions

Autoimmune Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Sokratis Apostolidis, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyra J Sacksith

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: October 8, 2019
• Study Start: February 24, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

US (1)