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 @ 3:48 PM
Ignite Modification Date:
2025-12-24 @ 3:48 PM
NCT ID:
NCT02650492
Eligibility Criteria:
Inclusion Criteria:
* \>18 years of age
* histologically confirmed malignant melanoma
* advanced melanoma disease (Stage III inoperable or Stage IV) that has progressed on standard first line treatment such as kinase inhibitor(s) and/or immunoregulatory monoclonal antibodies. Previously untreated patients with a dominant tumour lesion deemed suitable for local and highly tumour-destructive ablation may also be included
* time interval between previous systemic treatment and imILT of at least one month
* at least one lesion located in such a way (typically subcutaneously) that it can be treated without risk of skin necrosis or serious damage to other adjacent vital and healthy tissue
* verbal and written informed consent to participate
* adequate haematologic, renal and hepatic functions
* have an ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
Exclusion Criteria:
* known HIV infection
* autoimmune disease which is judged to reduce an anti-tumour immune response
* systemic corticosteroid medication
* bleeding diathesis
* pregnancy or breast-feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02650492
Study Brief:
Protocol Section:
NCT02650492