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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 - C4221011 (ARRAY-162-115)

Studio Clinico

Patologia: Melanoma

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: 1,

Linee di trattamento: Prima linea

Criteri di inclusione: 

Patients must meet all of the following criteria to be eligible for enrollment in the study:
- Ages Eligible for Study: 12 Years to 17 Years
- 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

Criteri di esclusione: 

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.

Schema di trattamento: 

Experimental: Safety Run-in Phase
- binimetinib taken twice daily (BID) and
- encorafenib taken once daily (QD)

Experimental: Expansion Phase
- binimetinib taken twice daily (BID) and
- encorafenib taken once daily (QD)

Trattamento sperimentale: 

Binimetinib + Encorafenib

Trattamento di controllo: 


Obiettivi primari dello studio: 

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.

Centri partecipanti

Nord Italia

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI

Riferimento: Dr. Andrea Ferrari
Telefono: 0223902588


Ospedale Infantile Regina Margherita di Torino
Piazza Polonia 94 - 10126 Torino - TO
NB: Arruolamento pazienti non ancora attivo

Riferimento: Prof.ssa Franca Fagioli
Telefono: 0113135230


Centro Italia

Azienda Ospedaliera Universitaria Senese
Viale Bracci 16 - 53100 Siena - SI
U.O.C. Immunoterapia Oncologica


Sud Italia e isole

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA
NB: Arruolamento pazienti non ancora attivo

Riferimento: Dr. Paolo Ascierto
Telefono: 0815903236

Informazioni Generali


Numero di iscrizione a registro: NCT03878719

Data di inserimento: 13.01.2021

Data di aggiornamento: 21.06.2022



Principal Investigator ITALIA

Azienda Ospedaliera Universitaria Senese - UOC Immunoterapia Oncologica

Riferimento: Dr. Info non disponibile

Telefono: 00000


Localita: Siena


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