Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03878719




Registration number
NCT03878719
Ethics application status
Date submitted
20/02/2019
Date registered
18/03/2019
Date last updated
3/04/2023

Titles & IDs
Public title
Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma
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
Secondary ID [1] 0 0
C4221011
Secondary ID [2] 0 0
ARRAY-162-115
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
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 × 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
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/08/2022
Sample size
Target
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03878719
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Pfizer Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03878719