Immune System Diseases

All Conditions

Autoimmune Diseases

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

Kyra J Sacksith

Terri M Laufer, MD

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).

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.

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.

Autoimmunity After Checkpoint Blockade

Mechanisms of Immunotoxicology in Cancer Patients

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.

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.

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.

University of Pennsylvania

All Drugs and Chemicals

Antiemetics

Gastrointestinal Agents

Anti-Allergic Agents

Central Nervous System Depressants

Dermatologic Agents

Immunomodulating Agents

Dimenhydrinate

Diphenhydramine

Promethazine

Emollients

All patients will receive the experimental emollients during 3 weeks.

Hydrating, hypo-allergenic, and anti- itching emollient and body lotion for immunotherapy-related skin reactions

Hydrating emollient + body lotion for immunotherapy-related side effects

Jeroen Mebis, MD, PhD

Jolien Robijns, PhD

Notwithstanding the continuous progress in cancer treatment, patients with cancer still have to cope with quality of life (QoL) - impairing complications. Especially an extensive spectrum of dermatologic toxicities has been associated with cancer treatments. The number and type of cutaneous toxicities have evolved over the past 50 years, paralleling the development of new immunomodulatory agents. The immunotherapy-related skin toxicities can significantly impede the patient's emotional, physical, social, and financial well-being resulting in a poor QoL. In rare cases of severe cutaneous reactions, treatment modifications are needed, resulting in a diminished overall survival.

Important organizations in the field of oncology and supportive care, such as the MASCC, the ASCO, and the ESMO, have developed guidelines for the management of cancer therapy- related cutaneous toxicities based on available scientific evidence. Still, for some interventions, the evidence of recommendation is moderate to insufficient. Therefore, it is essential to elucidate other new potential management strategies for dermatological complications of cancer treatment. Based on the previously mentioned supportive care guidelines for the ImmunoSkin project, two novel skin care products to tackle the cutaneous adverse events of immunotherapy have been developed.

The ImmunoSkin project general aim is to evaluate the efficacy of two novel skincare products to manage immunotherapy-related cutaneous toxicities.

Primary objective Evaluate the efficacy of two novel skin care products for the management of immunotherapy-related cutaneous adverse events

Secondary objective 1 Evaluate patient-relevant treatment benefit of two novel skin care products for immunotherapy-related cutaneous toxicities

Secondary objective 2 Evaluate the influence of two novel skin care products for immunotherapy-related cutaneous toxicities on the patient's quality of life

Secondary objective 3 Evaluate the safety of two novel skin care products for immunotherapy-related cutaneous toxicities

Novel Skin Care for Immunotherapy- Related Dermatologic Toxicities

Evaluation of Novel Skin Care Products for the Management of Immunotherapy- Related Dermatologic Toxicities

General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (i.e., gender, age, smoking history, work habits, physical activity, skin condition, alcohol use, and medication use). Furthermore, information about disease- and treatment-related risk factors will be collected through medical records (e.g., tumor type and stage, tumor site, treatment type, dosing etc).

The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) will be used to evaluate the skin reactions in the cancer patients

Patient Benefit Index is a standardized questionnaire measuring patients' treatment needs and treatment benefits for skin diseases. The PBI comprises two components:

1. Patient Needs Questionnaire measuring the importance of different treatment goals from the patient perspective.
2. Patient Benefit Questionnaire measuring the achievement of the treatment goals from the patient perspective.

The patients will be asked to complete a questionnaire to evaluate the intensity of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale

Dermatology Life Quality Index (DLQI) a questionnaire with 10 items and is used to measure QoL of dermatological patients.

The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions.

The patients will be asked to evaluate the general pleasantness and soothing effect of the skin care products. Furthermore, they will be asked to score their global satisfaction with the skin care products using a numerical rating scale.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Autoimmunity After Checkpoint Blockade	NCT04119713	Autoimmunity Cancer Immunotoxicity Oncology		18 Years -	University of Pennsylvania
Novel Skin Care for Immunotherapy- Related Dermatologic Toxicities	NCT04929834	Skin Toxicity Immunotoxicity	Hydrating emoll...	18 Years -	Jessa Hospital

Spots Global Cancer Trial Database for immunotoxicity