Identifying biomarkers for immune therapy in advanced melanoma patients
Biomarkers for the Activity of Immune Checkpoint Inhibitor Therapy in Patients With Advanced Melanoma
This study is trying to find specific markers in patients with advanced melanoma to see how well their immune therapy works and how it affects their treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 2 sites (Jette, Brabant and 1 other locations) |
| Trial ID | NCT02673970 on ClinicalTrials.gov |
What this trial studies
This observational study aims to screen patients with advanced malignant melanoma who are about to start treatment with immune checkpoint inhibitors (ICIs). It involves collecting baseline demographic data, treatment history, and ongoing outcome data related to ICI therapy, including blood samples every few weeks and archival tissue samples from melanoma metastases. The study will follow patients throughout their treatment and after they stop, gathering data on treatment response and survival outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals with histologically confirmed AJCC Stage IIIC or IV malignant melanoma who are about to initiate treatment with an immune checkpoint inhibitor.
Not a fit: Patients with non-malignant melanoma or those not eligible for immune checkpoint inhibitor therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify biomarkers that predict the effectiveness of immune checkpoint inhibitors in melanoma patients, leading to more personalized treatment approaches.
How similar studies have performed: Other studies have shown promise in identifying biomarkers for immune therapies, suggesting that this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically confirmed malignant melanoma; 2. AJCC Stage IIIC or IV melanoma with evaluable disease; 3. Treatment with an immune checkpoint inhibitor; 4. Willing and able to give written informed consent; 5. Accessible for treatment and follow-up; Exclusion Criteria: * non
Where this trial is running
Jette, Brabant and 1 other locations
- UZ Brussel — Jette, Brabant, Belgium (Recruiting)
- UZ Brussel — Jette, Brussels, Belgium (Recruiting)
Study contacts
- Principal investigator: Bart NEyns, MD; PhD — Universitair Ziekenhuis Brussel
- Study coordinator: Bart Neyns, MD; PhD
- Email: bart.neyns@uzbrussel.be
- Phone: 024746040
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.