Using PET-CT scans to predict response to anti-PD-1 therapy in melanoma patients
Early Response Assessment With Interim FDG PET-CT Imaging in Patients With Advanced Melanoma Treated by Immune Checkpoint Inhibitors Therapy Anti-PD1
This study is testing if PET-CT scans can help predict how well melanoma patients will respond to a specific immunotherapy treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Drugs / interventions | nivolumab, Pembrolizumab, immunotherapy |
| Locations | 1 site (Nice, CHU de NICE) |
| Trial ID | NCT03888950 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of FDG PET-CT scans as an early predictor of therapeutic response in patients with metastatic melanoma undergoing anti-PD-1 immunotherapy. A total of 20 patients will be enrolled and will undergo three PET-CT scans: one at baseline, one after two cycles of treatment, and a final scan three months after treatment initiation. The study will assess treatment response using PERCIST criteria, focusing on the relationship between immune cell activation and tumor response. The goal is to identify predictive markers that can guide treatment decisions for patients who may not respond to current therapies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced, histologically confirmed melanoma who are eligible for anti-PD-1 therapy.
Not a fit: Patients with ocular or mucosal melanoma, or those with contraindications to PET CT, are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for predicting which patients will benefit from anti-PD-1 therapy, potentially improving treatment outcomes.
How similar studies have performed: While the use of imaging to predict treatment response is an emerging field, this specific approach using FDG PET-CT in melanoma has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age greater than or equal to 18 years, * Patient with advanced melanoma proved histologically, not BRAF mutated, BRAFV600 mutated and wild mutated, cutaneous or unknown primary melanoma having an indication of treatment with anti-PD-1 immunotherapy by nivolumab or Pembrolizumab, * Patient having social insurance, * Patient who has signed informed consent. Exclusion Criteria: * Age less than 18 years, * Patient with ocular or mucosal melanoma, * Contraindication to PET CT examination: Severe claustrophobia, unbalanced diabetes (fasting hairy blood glucose ≥ 11 mmol), * Patient with only metastatic lesions less than 8 mm in size, with the exception of pulmonary nodules, * HIV and/or HCV (hepatitis C virus) and/or HBV (hepatitis B virus) positive serology, active autoimmune disease, * Withdrawal of informed consent, * Metastatic disease not confirmed histologically.
Where this trial is running
Nice, CHU de NICE
- CHU de Nice — Nice, CHU de NICE, France (Recruiting)
Study contacts
- Principal investigator: Micheline RAZZOUK-CADET, MD — Centre Hospitalier Universitaire de Nice
- Study coordinator: Micheline RAZZOUK-CADET, MD
- Email: razzouk-cadet.m@chu-nice.fr
- Phone: +33492035671
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.