ABOUT THIS STUDY
Patients must meet all of the following criteria to be eligible for enrollment in the study.
- Histologically confirmed diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma or unknown primary melanoma American Joint Committee on Cancer Stage IIIB, IIIC, or IV.
- Presence of BRAF V600E or V600K mutation in tumor tissue as determined by a local or central laboratory
- Adequate cardiac function:
- Left ventricular ejection fraction (LVEF) ≥ 50% as determined by ECHO or multi-gated acquisition (MUGA) scan and above the institutional lower limit of normal (LLN);
- Triplicate average baseline QTcF value ≤ 450 ms.
- Adequate bone marrow, organ function, and laboratory parameters:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L;
- Hemoglobin ≥ 9 g/dL with or without transfusions;
- Platelets ≥ 75 × 10⁹/L without transfusions;
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); in patients with liver metastases ≤ 5 × ULN;
- Total bilirubin ≤ 1.5 × ULN;
- Creatinine ≤ 1.5 × institutional ULN for age, or calculated creatinine clearance ≥ 70 mL/min/1.73 m² (following Schwartz formula).
- Adequate performance status at Screening:
- Patients < 16 years old: Lansky Performance Scale score ≥ 80
- Patients 16 to 17 years old: Karnofsky Performance Scale score ≥ 80
Patients meeting any of the following criteria are not eligible for enrollment in the
- Uveal or mucosal melanoma.
- Brain metastases that are uncontrolled or symptomatic, require steroids, are
potentially life-threatening or have required radiation within 28 days prior to
starting study drug.
- History or current evidence of retinal vein occlusion (RVO) or current risk factors
- Prior therapy with a BRAF inhibitor (e.g., dabrafenib, vemurafenib) and/or a MEK
inhibitor (e.g., trametinib, cobimetinib).
- Impaired cardiovascular function or clinically significant cardiovascular disease,
including any of the following:
- History of acute coronary syndromes (including myocardial infarction, unstable
angina, coronary artery bypass grafting, coronary angioplasty or stenting) < 6
months prior to screening,
- Symptomatic chronic heart failure, history or current evidence of clinically
significant cardiac arrhythmia and/or conduction abnormality < 6 months prior to
screening except atrial fibrillation and paroxysmal supraventricular tachycardia.
- Concurrent neuromuscular disorder associated with elevated creatine kinase (CK)
- Uncontrolled arterial hypertension despite medical treatment
- Presence of BRAFʷͭ or indeterminate melanoma in tumor tissue.
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