Status:
TERMINATED
Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Pierre Fabre Laboratories
Conditions:
Melanoma
Eligibility:
All Genders
12-17 years
Phase:
PHASE1
Brief Summary
This is a multicenter Phase 1b, open-label study to evaluate the pharmacokinetic, safety and efficacy of binimetinib and encorafenib co-administered to adolescent patients with BRAF V600-mutant advanc...
Detailed Description
The study did not recruit the desired number of subjects and as a result does not have sufficient data for quantitative statistical analyses. Additionally, results data cannot be reported because doin...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- Patients meeting any of the following criteria are not eligible for enrollment in the study.
- 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 (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.
Key Trial Info
Start Date :
August 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03878719
Start Date
August 3 2020
End Date
August 19 2022
Last Update
April 3 2023
Active Locations (1)
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1
Fondazione IRCCS Istituto Nazionale Dei Tumori
Milan, Lombardy, Italy, 20133