Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma
NCT03878719
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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.
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Descriptive Information | |||||
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Brief Title ICMJE | Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma | ||||
Official Title ICMJE | A Multicenter, Open-label Phase 1b Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma | ||||
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 advanced/metastatic melanoma. The study consists of a Safety Run-in Phase to determine the RDE (recommended dose in expansion), followed by an Expansion Phase. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE | Melanoma | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 18 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | September 5, 2025 | ||||
Estimated Primary Completion Date | March 20, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Key Inclusion Criteria: Patients must meet all of the following criteria to be eligible for enrollment in the study.
Key Exclusion Criteria: Patients meeting any of the following criteria are not eligible for enrollment in the study.
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years to 17 Years (Child) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
| ||||
Listed Location Countries ICMJE | Czechia, Italy, New Zealand, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03878719 | ||||
Other Study ID Numbers ICMJE | ARRAY-162-115 C4221011 ( Other Identifier: Alias Study Number ) | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Pierre Fabre Laboratories | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |