Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma
NCT01909453
ABOUT THIS STUDY
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- 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
- 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
Other protocol-defined inclusion/exclusion criteria may apply
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Descriptive Information | |||||||
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Brief Title ICMJE | Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma | ||||||
Official Title ICMJE | A 2-part Phase III Randomized, Open Label, Multicenter Study of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma | ||||||
Brief Summary | 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:
Part 2: Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms:
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Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Melanoma | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE | 899 | ||||||
Original Estimated Enrollment ICMJE | 900 | ||||||
Estimated Study Completion Date ICMJE | August 31, 2022 | ||||||
Actual Primary Completion Date | November 9, 2016 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply | ||||||
Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Argentina, Australia, Brazil, Canada, Colombia, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Poland, Portugal, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States | ||||||
Removed Location Countries | Czech Republic | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01909453 | ||||||
Other Study ID Numbers ICMJE | CMEK162B2301 C4221004 ( Other Identifier: Alias Study Number ) 2013-001176-38 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | March 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |