Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma

NCT03878719

Last updated date
Study Location
Monash University - Monash Health - Monash Medical Centre
Clayton, Victoria, 3168, Australia
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Melanoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12-17 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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 Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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[email protected]

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Advanced Information
Descriptive Information
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
  • Drug: binimetinib
    taken orally
  • Drug: encorafenib
    taken orally
Study Arms  ICMJE
  • Experimental: Safety Run-in Phase
    • binimetinib taken twice daily (BID) and
    • encorafenib taken once daily (QD)

    Dose levels by patient body surface area (BSA) for binimetinib and encorafenib tablets/capsules are specified in the protocol.

    Interventions:
    • Drug: binimetinib
    • Drug: encorafenib
  • Experimental: Expansion Phase
    • binimetinib taken twice daily (BID) and
    • encorafenib taken once daily (QD)

    Dose levels by patient body surface area (BSA) for binimetinib and encorafenib tablets/capsules and pediatric formulations are specified in the protocol.

    Interventions:
    • Drug: binimetinib
    • Drug: encorafenib
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
 (submitted: March 15, 2019)
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.

  • 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 × 10?/L;
    • Hemoglobin ? 9 g/dL with or without transfusions;
    • Platelets ? 75 × 10?/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 Criteria:

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 BRAF?? or indeterminate melanoma in tumor tissue.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Australia,   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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Pierre Fabre Laboratories
Investigators  ICMJE
Study Director:Pfizer Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP