A Phase II Study of BVD-523 in Metastatic Uveal Melanoma (NCT03417739) | Clinical Trial Compass
TerminatedPhase 2
A Phase II Study of BVD-523 in Metastatic Uveal Melanoma
Stopped: This was a Simon two stage design trial that terminated after the first stage due to lack of response.
United States13 participantsStarted 2018-03-26
Plain-language summary
This research study is studying a targeted therapy called BVD-523 as a possible treatment for advanced uveal melanoma.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must have histologically or cytologically confirmed stage IV uveal melanoma
* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
* Patients can have received any number of prior therapies for treatment of their uveal melanoma excluding prior treatment with an ERK inhibitor. Patients who have received prior MEK inhibition or other MAPK targeted agents will be allowed on study.
* Age ≥ 18 years of age.
* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
* Life expectancy of greater than 6 months
* Participants must have normal organ and marrow function as defined below:
* leukocytes ≥3,000/mcL
* hemoglobin ≥9.0 g/dL
* absolute neutrophil count ≥1,500/mcL
* platelets ≥100,000/mcL
* total bilirubin ≤1.5 × institutional upper limit of normal AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal, unless there is known liver involvement in which case ≤5.0 × institutional upper limit of normal
* creatinine within normal institutional limits OR
* creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
* Participants must have adequate c…