A study of binimetinib and encorafenib in patients aged 12 to 17 with a specific type of melanoma (BRAF V600-mutant melanoma) that cannot be completely removed by surgery or that has spread to other areas in the body.
- Conditions
- nresectable or metastatic BRAF V600-mutant melanomaMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-001946-32-CZ
- Lead Sponsor
- Array BioPharma Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 18
- Male or female 12 to < 18 years of age at the time of consent/assent.
- 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.
- Evidence of at least one evaluable lesion (measurable or non-measurable) as detected by radiological or photographic methods based on RECIST v1.1.
- Adequate cardiac function:
a. Left ventricular ejection fraction = 50% as determined by ECHO or MUGA scan and above the institutional lower limit of normal;
b. Triplicate average baseline QTcF value = 450 ms.
- Adequate bone marrow, organ function, and laboratory parameters:
a. Absolute neutrophil count = 1.5 × 109/L;
b. Hemoglobin = 9 g/dL with or without transfusions;
c. Platelets = 75 × 109/L without transfusions;
d. Aspartate aminotransferase and/or alanine aminotransferase = 2.5 × upper limit of normal (ULN); in patients with liver metastases = 5 × ULN;
e. Total bilirubin = 1.5 × ULN. Patients with documented Gilbert syndrome or hyperbilirubinemia due to non-hepatic cause (e.g., hemolysis, hematoma) may be enrolled following discussion and agreement with the Sponsor;
f. 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:
a. Patients < 16 years old: Lansky Performance Scale score = 80
b. Patients 16 to 17 years old: Karnofsky Performance Scale score = 80
- Female patients of childbearing potential must agree to take appropriate precautions to avoid pregnancy from screening through 8 weeks following end of therapy and must have a negative pregnancy test at Screening and predose at Day 1.
- Males must agree to take appropriate precautions to avoid fathering a child from Screening through 90 days following end of therapy.
Are the trial subjects under 18? yes
Number of subjects for this age range: 18
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Presence of BRAFwt or indeterminate melanoma in tumor tissue as determined by local and central laboratory.
- Known sensitivity or contraindication to any component of study treatment (binimetinib and encorafenib), or their excipients.
- 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 for RVO.
- Prior therapy with a BRAF inhibitor and/or a MEK inhibitor
- Impaired cardiovascular function or clinically significant cardiovascular disease, including any of the following:
a. History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting) < 6 months prior to screening,
b. 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.
- Impairment of gastrointestinal function.
- Uncontrolled arterial hypertension despite medical treatment.
- Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome.
- Known active hepatitis B and/or active hepatitis C infection.
- Patients who have undergone major surgery or radiotherapy = 2 weeks prior to starting study treatment or who have not recovered from side effects of such procedure.
- Pregnant or lactating females.
- History of Gilbert’s syndrome.
- Receipt of non-topical medication known to be a strong inhibitor or strong inducer of cytochrome P450 3A4 within 3 days prior to Screening.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method