Status:
COMPLETED
Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma
Lead Sponsor:
Pfizer
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 loc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 12 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2024
Estimated Enrollment :
921 Patients enrolled
Trial Details
Trial ID
NCT01909453
Start Date
September 12 2013
End Date
September 3 2024
Last Update
May 29 2025
Active Locations (282)
Enter a location and click search to find clinical trials sorted by distance.
1
Retinal Consultants of Alabama P.C.
Birmingham, Alabama, United States, 35233
2
UAB Callahan Eye Hospital
Birmingham, Alabama, United States, 35233
3
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35233
4
UAB The Kirklin Clinic
Birmingham, Alabama, United States, 35233