A study comparing combination of LGX818 plus MEK162 vs. vemurafenib, and LGX818 plus MEK162 vs. LGX818 in BRAF mutant melanoma.

Phase 1

• Conditions: unresectable or metastatic BRAF V600 mutant melanoma; MedDRA version: 21.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001176-38-GR
• Lead Sponsor: Array BioPharma Inc.(a wholly owned subsidiary of Pfizer Inc.)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-21
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• Diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma or unkown primary melanoma (AJCC Stage IIIB, IIIC, or IV)
• Presence of BRAF V600E and/or V600K mutation in tumor tissue prior to randomization
• Naïve untreated patients or patients who have progressed on or after prior first-line immunotherapy for unresectable locally advanced or metastatic melanoma; prior adjuvant therapy is permitted (e.g. IFN, IL-2 therapy, any other immunotherapy or radiotherapy), except the administration of BRAF or MEK inhibitors.
• Evidence of at least one measurable lesion as detected by radiological or photographic methods
• ECOG performance status of 0 or 1
• Adequate bone marrow, organ function, cardiac and laboratory parameters
• Normal functioning of daily living activities

Other protocol-defined inclusion criteria may apply

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 675
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225

Exclusion Criteria

• Any untreated central nervous system (CNS lesion)
• Mucosal or uveal melanoma
• History of leptomeningeal metastases
• History of or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g uncontrolled glaucoma or ocular hypertension, history of
hyperviscosity or hypercoagulability syndromes);
• Patients with washout period <6 weeks from the last dose of ipilimumab or other immunotherapy.
• Any previous systemic chemotherapy treatment, extensive radiotherapy or investigational agent other than immunotherapy, or patients who have received more than one line of immunotherapy for locally advanced unresectable or metastatic melanoma.
• History of Gilbert's syndrome
• Prior therapy with a BRAF inhibitor and/or a MEK- inhibitor
• Impaired cardiovascular function or clinically significant cardiovascular diseases
• Uncontrolled arterial hypertension despite medical treatment
• HIV positive or active Hepatitis B, and/or active Hepatitis C
• Impairment of gastrointestinal function
• Patients with neuromuscular disorders that are associated with elevated CK.
• Pregnant or nursing (lactating) women
•Patients taking non-topical medication known to be a strong inhibitor of CYP3A4
• Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study

Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified