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 @ 12:43 PM
Ignite Modification Date:
2025-12-24 @ 12:43 PM
NCT ID:
NCT02027961
Eligibility Criteria:
Inclusion Criteria:
* Adults \>= 18 years old
* Histologically confirmed cutaneous melanoma that is either Stage IIIc (unresectable) or Stage IV (metastatic) and determined to be BRAF V600E or V600K mutation-positive (cohort A) or mutation-negative (cohorts B and C)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Measurable disease by radiographic or physical examination
* Adequate organ and marrow function
* Willingness to provide consent for biopsies positive or BRAF WT measurable disease and adequate organ and marrow function
Exclusion Criteria:
* Prior treatment with a BRAF inhibitor or MEK inhibitor
* Any prior Grade \>= 3 immune-related adverse event while receiving immunotherapy
* Active or prior documented autoimmune disease within the past 2 years
* History of or current risk for retinal vein occlusion (RVO) or central serous retinopathy (CSR)
* History of or current cardiovascular risk including myocardial infarction, \>= Class II congestive heart failure, uncontrolled arrhythmias, or refractory hypertension
* Active, untreated central nervous system (CNS) metastases
* Women who are pregnant or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02027961
Study Brief:
Protocol Section:
NCT02027961