Immune-Related Adverse Events and Associated Biomarkers in Patients Receiving Cancer Immunotherapy
NCT ID: NCT06089967
Last Updated: 2025-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2022-10-05
2024-12-06
Brief Summary
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Detailed Description
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* 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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Brent Hanks, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Duke Cancer Institute
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00109576
Identifier Type: -
Identifier Source: org_study_id
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