Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04656873 |
| Other study ID # |
LCCC1937 |
| Secondary ID |
18-0560 |
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 20, 2021 |
| Est. completion date |
April 2031 |
Study information
| Verified date |
January 2024 |
| Source |
UNC Lineberger Comprehensive Cancer Center |
| Contact |
Shivani R Surati, MS |
| Phone |
919-966-7597 |
| Email |
shivani_surati[@]med.unc.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Immunotherapy, especially immune checkpoint inhibitors (ICIs), are effective in treating many
different types of cancers. ICIs fight cancer by driving the immune system into an "activated
state" that makes it harder for tumor cells to hide and easier for the immune system to
destroy them. In doing this, oncologists risk "over activation" where immune cells can cause
side effects that could affect any part of the body. These are known as immune related
adverse events (irAEs). While irAEs are a known risk of ICIs, scientists and doctors do not
understand how they develop, who is more likely to get them, and what is the best way to
manage them while still getting the anti-tumor effects from ICIs. The aim of this project is
to build an infrastructure for researchers to collaborate in clinical, translational, and
basic science research focused on understanding and managing immune related adverse events
(irAEs). The investigators will collect research data and samples from patients who receive
ICI treatment, including when patients might experience immunotherapy side effects, to store
for use in future research studies.
Description:
BACKGROUND
Tumors evolve to evade the body's anti-tumor immune response by targeting cancer cells and
downregulating immune pathways. Immune checkpoint inhibitors (ICIs) prevent this tumor
evasion by driving the immune system into an "activated state", and upregulating the
patient's immune system to destroy tumor cells. While enhancing the immune system disrupts
tumor growth, in doing so oncologists risk "over activation" resulting in immune-mediated
toxicity known as immune related adverse events (irAEs).
irAEs are an emerging disease entity, affecting many organ systems with diverse clinical
presentations similar to known autoimmune diseases, such as systemic lupus erythematosus,
inflammatory arthritis, psoriasis, thyroiditis, inflammatory bowel disease, hepatitis,
pneumonitis, and myocarditis. The most common presentations of irAEs are dermatologic
(rashes), endocrine (hypo/hyper-active thyroid, hypophysitis, adrenal), and gastrointestinal
(colitis). However, any organ system can be affected resulting in a wide array of irAEs.
Immunotherapy, especially ICIs, are being increasingly used in a wide variety of cancer
therapy and have been found to effectively treat many different types of cancers. ICIs are
monoclonal antibodies targeting cytotoxic T-cell lymphocyte antigen 4 (CTLA-4), programmed
cell death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) pathways. CTLA-4 and
PD-1/PD-L1 are involved in deactivating T-cell and attenuating T-cell effector response,
respectively. These are already being used to treat a wide range of cancers with several
clinical trials currently underway examining response of additional cancer types to current
ICIs as well as for developing new ICI treatments. The investigators anticipate that there
will be additional immune checkpoint targets in the future given that some are already in
clinical trials and the high interest in cancer immunotherapy.
The goal of this project is to collect, curate, and store data and specimens for future
studies presented in separate protocols. This patient registry will provide biological
specimens for biomarker analysis, immunophenotyping, genetic and microbiome analysis to
understand development of autoimmune conditions. Clinical data can be used for
epidemiological studies as well as clinical, functional, psychosocial and economic outcomes
research regarding impact of ICIs and irAEs on cancer patients. Moreover, this infrastructure
can inform the development of clinical algorithms and help determine the effectiveness of
medical interventions targeting cancer outcomes and irAEs.
STUDY OUTLINE
Patients will be involved in the study from the time of consent (before starting ICI therapy)
until 2 years after the end of ICI treatment. The investigators will collect clinical data
(including demographic information, medical history, cancer diagnosis and treatment,
management of adverse events, and outcomes), specimens (including blood, urine, stool,
biofluids and/or tissue samples), and questionnaires at multiple time points. All patient
data and samples will be linked by a de-identified study specific identifier (study ID) and
will be stored indefinitely until used or patient withdraw from the study in writing.
STUDY OBJECTIVES
The overall goal of this project is to build an infrastructure that will provide resources
for researchers at UNC Chapel Hill and beyond to conduct multidisciplinary clinical,
translational, and basic research in elucidating pathways involved in cancer biology and
irAEs.
