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

Prospective Study to Evaluate Immune-Related Adverse Events and Associated Biomarkers in Patients Receiving Cancer Immunotherapy

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Immune-related Adverse Event
• Intervention / Treatment: Other: Medical chart review

Detailed Description

This is a prospective biospecimen and clinical data collection study in adult participants with 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 who are being treated with any of the following therapies alone or in combination:

• anti-PD-1 (nivolumab, pembrolizumab, cemiplimab)
• anti-CTLA-4 (ipilimumab or tremelimumab)
• anti-PD-L1 (atezolizumab, durvalumab, avelumab)
• anti-LAG3 (relatlimab)

Additional agents with similar mechanisms of action, e.g., targeting any of the above proteins may be included. Those with other targets may be considered on a case-by-case basis.

The goal of this study is to collect patient specimens from time points before, during, and after cancer immunotherapy discontinuation. Participants must agree to collection of biospecimens and clinical data. Biospecimens to be collected under this study include but are not limited to, blood specimens, primary or metastatic tumor specimen(s), end organ biospecimens such as bronchoalveolar/synovial fluid or colon tissues biopsies, and any other tissues that are biopsied for evaluation of a potential immune-related adverse events (irAE). Clinical data, including, but not limited to, cancer diagnosis, staging, treatment, toxicities and management, will be collected for up to one year after discontinuation of cancer immunotherapy treatment.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Male or female 18 years of age or older.
2. 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.
3. 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.
4. 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.

Exclusion Criteria:

1. Cytotoxic chemotherapy or biologic agents (eg. cytokines or antibodies) within 4 weeks of treatment initiation.
2. Steroids equivalent to or greater than prednisone 10 mg daily within 2 weeks of treatment initiation.
3. Antibiotic therapies within 2 weeks of treatment initiation.
4. 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.
5. Organ transplant recipients on immunosuppressive agents.
6. Immunosuppressive drugs in the last 12 weeks for reasons other than autoimmune disease or organ transplants.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Brent Hanks, MD PhD, Duke Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2022
• Primary Completion (Actual): December 6, 2024
• Study Completion (Actual): December 6, 2024

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: immunotherapy; immuno-oncology; immune checkpoint inhibitors; immune-related adverse events
• Other Study ID Numbers: Pro00109576

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No