Clinical trial NCT06089967: Immune-Related Adverse Events and Associated Biomarkers in Patients Receiving Cancer Immunotherapy
Official title: Prospective Study to Evaluate Immune-Related Adverse Events and Associated Biomarkers in Patients Receiving Cancer Immunotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Immune-related Adverse Event
Keywords: immunotherapy
immune-related adverse events
immune checkpoint inhibitors
immuno-oncology
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult cancer patients at Duke University Health Systems starting immune checkpoint inhibitor therapy.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants cancer patients with immune-related adverse events with biospecimens and clinical data collected
timeFrame: Up to 1 year after the end of immune checkpoint inhibitor therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Cancer Institute
name: Brent Hanks, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: