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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT06556004
Eligibility Criteria:
Inclusion Criteria:
* People over 18 years old
* Histological confirmation of AJCC malignant melanoma Stage IIIC or IV.
* Performance Status 0 or 1 in the scale of Eastern Cooperative Oncology Group (ECOG).
* Life expectancy over 3 months
* Prior to the beginning of the study, participants should be aware of the risk information and express their willingness to participate by a written consent.
* Disease progression after the use of checkpoint inhibitors immunotherapy.
Exclusion Criteria:
* History of other cancers diagnosed in a period of less than 5 years, except for squamous or basal cell skin cancer, cervical cancer in situ or superficial bladder cancer, properly treated and cured.
* Ocular melanoma.
* Old or recent story of autoimmune disease.
* Systemic use of corticosteroids or immunosuppressants within 28 days prior to the start of the study. The use of inhalation corticosteroids is allowed.
* Adrenal insufficiency, requiring the use of corticosteroids, at any dose.
* Presence of symptomatic cardiac arrythmias, atrial fibrillation or prolongation of the QT-interval.
* Arterial hypertension that is not under control (systolic pressure higher than 160 mmHg and or diastolic pressure higher than 100 mmHg.
* History of symptomatic cardiovascular diseases over the last 12 months (unstable coronary disease, symptomatic vascular disease, heart failure/ functional capacity III or IV according to the New York Heart Association, history of cerebrovascular accident including transient ischemic attack, untreated deep vein thrombosis, pulmonary embolism).
* History of HIV, HBV and / or HCV infections
* Major surgery over the last 28 days
* History of splenectomy
* Uncontrolled infection or any known medical condition, that according to the investigator's interpretation may increase the risk involved in the participation of the study, or interfere with treatment or follow ups, or interfere with the interpretation of safety results.
* Inability to carry out the informed consent process.
* History of allogeneic bone marrow transplant.
* Ongoing pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06556004
Study Brief:
Protocol Section:
NCT06556004