Immune-Related Adverse Events and Associated Biomarkers in Patients Receiving Cancer Immunotherapy

NCT06089967 | Completed

• 1 other identifier: Pro00109576
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to collect body samples like blood and tissue and health information from people receiving immune-based treatment for cancer. The body samples and health information will be stored for future research to understand more about side effects related to immune-based treatments for cancer.

Conditions

Cancer; Immune-related Adverse Event

Keywords

immunotherapy; immune-related adverse events; immune checkpoint inhibitors; immuno-oncology

Outcome Measures

Primary Outcomes (1)

• Number of participants cancer patients with immune-related adverse events with biospecimens and clinical data collected

  Clinical database of participants receiving immune checkpoint inhibitors paired with biospecimen collection. Participant specimens are collected at time points before, during, and after cancer immunotherapy discontinuation. Clinical data collection includes, but is not limited to patient demographics, primary disease (site, histology, histologic grade, staging system used, staging, molecular markers), prior cancer treatment, immunotherapy received, time of onset, treatment received for irAEs, and disease response to treatment.

  Up to 1 year after the end of immune checkpoint inhibitor therapy

Study Arms (1)

Immune checkpoint inhibitor treatment

Adult cancer patients starting standard of care immune checkpoint inhibitor therapy. Participants willing to provide biospecimens (blood, body fluids and/or tissue) for research purposes. Participants will be followed for samples, irAEs and clinical data for up to one year after the end of treatment.

Other: Medical chart review

Interventions

Medical chart review OTHER

Clinical data for all enrolled patients will be abstracted from the electronic medical record. This will include but will not be limited to patient demographics, primary disease (site, histology, histologic grade, staging system used, staging, molecular markers), prior cancer treatment, immunotherapy received, time of onset, treatment received for irAEs, and disease response to treatment. Clinical data will be collected for up to one year after discontinuation of cancer immunotherapy treatment.

Immune checkpoint inhibitor treatment

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

Adult cancer patients at Duke University Health Systems starting immune checkpoint inhibitor therapy.

You may qualify if:

• Male or female 18 years of age or older.
• Selected for standard of care therapy with a checkpoint inhibitor or immunotherapeutic as recommended by their medical oncologist, including but not limited to: pembrolizumab, nivolumab, cemiplimab, ipilimumab, tremelimumab, durvalumab, atezolizumab, avelumab, and relatlimab.
• Histologically confirmed diagnosis with a malignancy, including but not limited to: melanoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma, basal cell carcinoma, non-small cell lung cancer, small cell lung cancer, renal cell carcinoma, urothelial cancer, Hodgkins lymphoma, follicular lymphoma, head and neck carcinoma, hepatocellular carcinoma, breast carcinoma, gastric carcinoma, esophageal carcinoma, cholangiocarcinoma, pancreatic cancer, and any microsatellite instability-high (MSI-H) malignancy.
• Legally be allowed to sign as well as be able to understand and date the study and written informed consent to take part in all mentioned evaluations.

You may not qualify if:

• Cytotoxic chemotherapy or biologic agents (eg. cytokines or antibodies) within 4 weeks of treatment initiation.
• Steroids equivalent to or greater than prednisone 10 mg daily within 2 weeks of treatment initiation.
• Antibiotic therapies within 2 weeks of treatment initiation.
• Previously confirmed diagnosis of an autoimmune disease felt by the investigators to complicate data analysis. Those autoimmune conditions generally felt to be benign such as atopic dermatitis will be considered for enrollment on a case-by-case basis.
• Organ transplant recipients on immunosuppressive agents.
• Immunosuppressive drugs in the last 12 weeks for reasons other than autoimmune disease or organ transplants.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Collection of blood, body fluids, and tissue for research.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Brent Hanks, MD PhD

  Duke Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 19, 2023
• Study Start: October 5, 2022
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)