A study comparing Combination of LGX818 plus MEK162 vs. vemurafenib, and LGX818 monotherapy vs. vemurafenib 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-NL
• 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: 2013-07-04
• Last Update Posted: 19 April 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 (AJCC Stage IIIB, IIIC, or IV)
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 active/non-stable brain lesion
• Non-cutaneous melanoma
• History of leptomeningeal metastases
• History of or current evidence of retinal vein occlusion (RVO)
• Patients with washout period < 12 weeks from the last dose of
ipilimumab or other immunotherapy.
• Any previous 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