Identifying autoantibodies before immune therapy for cancer
Prospective Study of Autoimmune Endocrine Disease-related Antibodies Before the Start of Immune Checkpoint Inhibitor Therapy
This study is testing if certain antibodies in the blood can help predict if cancer patients will have side effects from immune therapy and how well the treatment might work for them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brugmann University Hospital Academic / other |
| Drugs / interventions | chemotherapy, ipilimumab, tremelimumab, cemiplimab, dostarlimab, pembrolizumab, nivolumab, atezolizumab, avelumab, durvalumab, immunotherapy |
| Locations | 3 sites (Brussels and 2 other locations) |
| Trial ID | NCT06993727 on ClinicalTrials.gov |
What this trial studies
This study aims to identify biomarkers that predict the development of autoimmune side effects in patients undergoing immune checkpoint inhibitor therapy for cancer. By analyzing blood samples for specific autoantibodies, the researchers hope to determine if the presence of these antibodies can indicate both the likelihood of adverse effects and the potential for improved cancer outcomes. The focus is particularly on thyroid autoantibodies and their correlation with thyroiditis and oncologic prognosis, as well as exploring less common endocrinopathies. The study will include all eligible patients consenting to participate at the specified locations in Brussels.
Who should consider this trial
Good fit: Ideal candidates are patients eligible for immune checkpoint therapy who consent to participate in the study.
Not a fit: Patients who are pregnant will not benefit from this study due to exclusion criteria.
Why it matters
Potential benefit: If successful, this study could help identify patients at risk for autoimmune side effects while also predicting better cancer treatment outcomes.
How similar studies have performed: While the approach of identifying biomarkers for autoimmune reactions in immunotherapy is gaining interest, this specific focus on endocrine autoantibodies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All subjects eligible for immune checkpoint therapy at the participating study sites. The cohort will consist of all subjects who consent to participate, and to use their information for future research and publication in a scientific journal. Exclusion Criteria: * Pregnancy
Where this trial is running
Brussels and 2 other locations
- C.H.U. Saint-Pierre — Brussels, Belgium (Recruiting)
- CHU Brugmann — Brussels, Belgium (Recruiting)
- HUB - Institut Jules Bordet — Brussels, Belgium (Recruiting)
Study contacts
- Study coordinator: Jeroen de Filette, MD
- Email: Jeroen.DEFILETTE@chu-brugmann.be
- Phone: 024772067
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.