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Interferon Signature in Anti-CTLA-4 and Anti-PD-1/PD-L1-Treated Cancer Patients Compared With Systemic Autoimmune Disease Patients

Recruitingn/aAges 18 Years - anyAllHospital Universitario Araba
NCT07249060 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study aims to identify a way to predict the side effects that some people with cancer experience when receiving immunotherapy. These side effects, known as immune-related adverse events (irAEs), occur when the immune system mistakenly attacks healthy tissues, like certain autoimmune diseases. At present, clinicians lack reliable tests to determine who is most likely to develop these reactions. The goal of this study is to determine whether substances in the blood called interferons (IFNs) could serve as early warning markers. The study will include 300 people with cancer who are about to begin immunotherapy. To provide a meaningful comparison, the investigators will also enroll 40 individuals with autoimmune diseases such as lupus. Understanding how IFN levels differ between these groups may help clarify whether IFN patterns in cancer patients resemble those seen in autoimmune dise

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📋 Eligibility rules (as published)
ICI cohort: Inclusion Criteria: * Initiation of treatment with a single ICI or dual ICI therapy in accordance with current clinical guidelines; * Patients who are treatment-naïve to ICIs; and * Age ≥18 years. Exclusion Criteria: * Estimated mortality of less than 3 months from the start of treatment; * Current combination therapy with chemotherapy, tyrosine kinase inhibitors, or other tumor-specific treatments; * Contraindication to treatment with ICIs (documented hypersensitivity, severe active autoimmune disease, Eastern Cooperative Oncology Group \[ECOG\] ≥3); * Ongoing immunosuppressive therapy, including prednisone at doses \>10 mg/day or equivalent. SAD cohort: Inclusion Criteria: * Meeting classification criteria for Systemic Lupus Erythematosus (SLE) (ACR/EULAR 2019), Primary Sjögren's Syndrome (pSS) (ACR/EULAR 2016), Systemic Sclerosis (SSc) (ACR/EULAR 2013), and/or Idiopathic Inflammatory Myopathy (IIM) (ACR/EULAR 2017). * Age ≥18 years old. Exclusion Criteria: * Estimated mortality less than 3 months from the start of follow-up. * Active immunosuppressive treatment, including prednisone at doses \>10 mg/day or equivalent. * Recent diagnosis (\<1 year) of cancer, with the exception of non-melanoma skin cancer, or currently receiving active oncology-specific treatment.
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What it tests

  • Immune Checkpoint Inhibitors
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Where

1 site
Hospital Universitario de Navarra
Pamplona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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