Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT03888950
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03888950
Study Brief:
Protocol Section:
NCT03888950