Status:
COMPLETED
Immune-Related Adverse Events and Associated Biomarkers in Patients Receiving Cancer Immunotherapy
Lead Sponsor:
Duke University
Conditions:
Cancer
Immune-related Adverse Event
Eligibility:
All Genders
18+ years
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 wil...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 5 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 6 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06089967
Start Date
October 5 2022
End Date
December 6 2024
Last Update
January 28 2025
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710