Using PET-CT scans to predict response to anti-PD-1 therapy in melanoma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.