NCT06089967

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cancer
• Immune-related Adverse Event

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-05
• Primary completion: 2024-12-06
• Completion: 2024-12-06
• First posted: 2023-10-19
• Last updated: 2025-01-28

Locations

1 site across 1 country: United States