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Study Comparing Combination o...

Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma

NCT ID: NCT01909453

Last Updated: 2025-05-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

921 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-12

Study Completion Date

2024-09-03

Brief Summary

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This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized.

Part 1:

Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms:

1. LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm)
2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or
3. vemurafenib 960 mg BID (denoted as vemurafenib arm)

Part 2:

Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms:

1. LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or
2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm)

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Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LGX818 450 mg + MEK162

LGX818 450 mg QD + MEK162 45 mg BID

Group Type EXPERIMENTAL

LGX818

Intervention Type DRUG

LGX818- Orally 100 mg and 50 mg capsules

MEK162

Intervention Type DRUG

MEK162- Orally 15 mg tablets

Vemurafenib

Vemurafenib 960 mg BID

Group Type ACTIVE_COMPARATOR

vemurafenib

Intervention Type DRUG

Tablets in bottles or blisters 240 mg

LGX818 300 mg + MEK162

LGX818 300 mg QD + MEK162 45 mg BID

Group Type EXPERIMENTAL

LGX818

Intervention Type DRUG

LGX818- Orally 100 mg and 50 mg capsules

MEK162

Intervention Type DRUG

MEK162- Orally 15 mg tablets

LGX818

LGX818 300 mg QD

Group Type EXPERIMENTAL

LGX818

Intervention Type DRUG

LGX818- Orally 100 mg and 50 mg capsules

Interventions

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LGX818

LGX818- Orally 100 mg and 50 mg capsules

Intervention Type DRUG

MEK162

MEK162- Orally 15 mg tablets

Intervention Type DRUG

vemurafenib

Tablets in bottles or blisters 240 mg

Intervention Type DRUG

Other Intervention Names

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Zelboraf PLX4032 RO5185426

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma or unknown primary melanoma (AJCC Stage IIIB, IIIC, or IV)
* Presence of BRAF V600E 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 resectable locally advanced or metastatic melanoma; prior adjuvant therapy is permitted (e.g. IFN, IL-2 therapy, any other immunotherapy, radiotherapy or chemotherapy), 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

Exclusion Criteria

* Any untreated central nervous system (CNS) lesion
* Uveal and mucosal melanoma
* History of leptomeningeal metastases
* History of or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or history of retinal degenerative disease
* 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; Ipilimumab (adjuvant) or other immunotherapy treatment must have ended at least 6 weeks prior to randomization
* 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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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