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Closed (no longer recruiting)Last updated: 5 February 2024

ARRAY 165-112: This Phase I trial is evaluating how safe and effective combining to targeted therapies (binimetinib and encorafenib) is in adolescents with BRAF V600-mutant advanced or metastatic melanomaA Multicenter, Open-label Phase 1b Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma

Clinical summary

Summary

This is an open-label, non-randomised trial with two phases. The first phase, the Safety Run-In Phase, is to determine the recommended dose for the second phase, the Expansion Phase. Binimetinib will be taken twice daily (orally) and encorafenib will be taken once daily (orally). Dose levels by patient body surface area for binimetinib and encorafenib tablets/capsules are specified in the protocol.

Conditions

This trial is treating patients with melanoma.

Cancer

Skin Cancers Skin

Age

People12 - 17

Phase

I

Trial Acronym

ARRAY 165-112

More information

Trial Identifiers

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Trial sponsor

Pfizer

Scientific Title

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

Eligibility

Inclusion

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

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.

Inclusion

  • You are able to swallow medication by mouth.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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