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:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT06236360
Eligibility Criteria:
Inclusion Criteria:
* age ≥18 years
* pathophysiologically confirmed cutaneous melanoma stage IV or inoperable stage IIIC,
* radiologically measurable disease on computerized tomography (CT) or positron emission tomography (PET)/CT,
* The multidisciplinary team recommended initiation of treatment with dual immunotherapy with anti-PD-1 + anti-CTLA4 immunotherapy
* written informed consent prior to participation
* willingness to monitor and adjust the dietary regimen if necessary
* Eastern Cooperative Oncology Group (ECOG) status 0-1.
Exclusion Criteria:
* lifetime history of psychiatric disorders
* active brain metastases
* active autoimmune disease
* systemic use of equal or more than 10 mg of prednisone or an appropriate corticosteroid equivalent during screening
* exposure to antibiotics and probiotics or other supplements that can affect the study outcome during screening within the last 3 weeks,
* uncontrolled diabetes
* history of clinically significant drug or alcohol abuse within the last 6 months
* specific dietary habits that are not inclined or able to change or the existence of food allergy or intolerance to certain food
* inability or refusal to participate in all research procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06236360
Study Brief:
Protocol Section:
NCT06236360