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 @ 1:40 PM
Ignite Modification Date:
2025-12-24 @ 1:40 PM
NCT ID:
NCT02379195
Eligibility Criteria:
Inclusion Criteria:
Histologically confirmed unresectable stage III or stage IV metastatic melanoma Metastasis available for surgical resection (about 2 cm3) and residual measurable disease after resection
ECOG performance status 0-1
Life expectancy ≥ 3 months
No significant toxicity from prior treatments
Adequate renal, hepatic and hematologic function
Women of childbearing potential (WOCBP) and men in a sexual relationship with a WOCBP must be using an effective method of contraception during treatment and for at least 6 months after completion af treatment.
Able to comprehend the information given and willing to sign informed consent
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Exclusion Criteria:
Other Malignancies, unless followed for ≥ 5 years with no sign of disease, except squamous cell carcinoma or adequately treated carcinoma in situ colli uteri.
Cerebral metastasis. Patients with previously treated CNS metastases can participate if CNS metastases are surgically removed or treated with stereotactic radiosurgery and stable ≥ 28 days after treatment measured by MRI. Patients with asymptomatic, stable and untreated CNS metastasis can in be included according to investigators and sponsors decision.
Patients with ocular melanoma
Severe allergies, history of anaphylaxis or known allergies to the administered drugs.
Serious medical or psychiatric comorbidity
Creatinine clearance \< 70 ml/min
Acute or chronic infection with e.g. HIV, hepatitis, tuberculosis
Severe and active autoimmune disease
Pregnant and nursing women
Need for immunosuppressive treatment, e.g. corticosteroids or methotrexate
Concomitant treatment with other experimental drugs
Patients with uncontrolled hypercalcemia
Less than four weeks since prior systemic antineoplastic treatment at the time of treatment.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02379195
Study Brief:
Protocol Section:
NCT02379195