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:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT06251934
Eligibility Criteria:
Inclusion criteria:
* Diagnosis of melanoma (ICD-9 172x \& ICD-10 C43 or D03x)
* ≥2 documented clinical encounters on different days in the Flatiron network on or after 01 January 2011
* Pathologic unresectable stage III or IV at initial diagnosis after 01 January 2011, or earlier stage disease accompanied by development of a first locoregional recurrence after 01 January 2011
* Diagnosis of MM after 01 January 2011
* Evidence of a BRAF-positive result at any point in time
* Treatment with one of the following 1L therapies on or after 01 January 2014:
* IO (nivolumab, pembrolizumab, or ipilimumab + nivolumab)
* TT (dab/tram)
* At least 18 years of age at the time of initiation of 1L therapy
* At least 6-months of continuous follow-up from the time of initiation of 1L therapy
Exclusion Criteria:
* Lacking relevant unstructured documents (i.e., information such as free text from a physician note or pathology report that is captured systematically during the data abstraction process) in the Flatiron Health database
* Evidence of non-skin melanoma (ocular, subungual, mucosal, palmar, plantar)
* Documented receipt of a clinical study drug, defined as any uncancelled order, administration, or oral episode for a clinical study drug for cancer at any time prior to or during 1L treatment
* Presence of leptomeningeal disease (ICD-9 198.4 \& ICD-10 C79.32 or C79.49)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06251934
Study Brief:
Protocol Section:
NCT06251934