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 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
NCT ID:
NCT02414750
Eligibility Criteria:
Inclusion Criteria:
* Patients with histologically confirmed melanoma, either unresectable stage IIIc or stage IV metastatic melanoma, as defined by AJCC 7th edition.
* Patients must be naïve to treatment for locally advanced unresectable or metastatic disease. Prior immunotherapy (including ipilimumab) is allowed.
* Documentation of BRAFV600E or BRAFV600K mutation-positive status in melanoma tumor tissue (archival or newly obtained tumor samples).
* Measurable disease per RECIST v1.1, which are accessible to biopsies.
* Biopsy lesion is within scan reach of diagnostic CT and PET-CT (thorax- abdomen-pelvis)
* ECOG performance status of 0 or 1.
* Male or female patient aged ≥ 18 years.
* Life expectancy ≥ 12 weeks.
* Adequate hematologic and end organ function within 14 days prior to first dose of study drug treatment.
Exclusion Criteria:
* History of prior RAF or MEK pathway inhibitor treatment.
* Palliative radiotherapy, major surgery or traumatic injury within 14 days prior to the first dose of study treatment.
* Active malignancy within the past 3 years other than melanoma that could potentially interfere with the interpretation of efficacy measures, except for patients with resected BCC or SCC of the skin, melanoma in-situ, carcinoma in-situ of the cervix, and carcinoma in-situ of the breast.
* History of or evidence of retinal pathology, clinically significant cardiac dysfunction, patients with active CNS lesions, renal or liver dysfunction as described in main protocol (REPOSIT NL48639.031.14).
* Pregnant, lactating, or breast-feeding.
* Unwillingness or inability to comply with study and follow-up procedures (i.e. severe anxiety disorder preventing PET/CT imaging.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02414750
Study Brief:
Protocol Section:
NCT02414750