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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT04985604
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent by participants ≥ 12 years of age either a Consent or an Assent Form will be provided to the patient based on their capacity, local regulations, and guidelines.
* Participants must have a histologically confirmed diagnosis of melanoma or other solid tumor and a BRAF fusion, CRAF/RAF1 fusion, or CRAF/RAF1 amplifications obtained through a tumor or liquid biopsy as assessed by genomic sequencing, polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or another clinically accepted molecular diagnostic method recognized by local laboratory or regulatory agency.
* Participants must have radiographically-recurrent or radiographically-progressive disease that is measurable using the appropriate tumor response criteria (e.g. RECIST version 1.1 or RANO).
* Archival tumor tissue (preferably less than 3 years old) or fresh tumor tissue for correlative studies is required
* If brain metastases are present, they must have been previously treated and be stable as assessed by radiographic imaging
Exclusion Criteria:
* Prior therapy of any RAS-, RAF-, MEK-, or ERK-directed inhibitor therapy
* Known presence of concurrent activating mutation
* Participants with current evidence or a history of central serous retinopathy (CSR), retinal vein occlusion (RVO)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT04985604
Study Brief:
Protocol Section:
NCT04985604