Clinical trial · Observational
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
NCT06089967CI-TRIAL-00085207IMBARCcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Immune-related Adverse Event | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Medical chart review | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Immune checkpoint inhibitor treatment
- description
- 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.
- interventionNames
- Other: Medical chart review
Primary outcomes (1)
- 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
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.