LGX818 in Combination With Agents (MEK162; BKM120; LEE011; BGJ398; INC280) in Advanced BRAF Melanoma (LOGIC)
Melanoma

About this trial
This is an interventional treatment trial for Melanoma focused on measuring open-label study, BRAF inhibitor, LGX818, MEK1620, MAPK1/2 inhibitor, Pi3K inhibitor, FGFR, c-Met, CDK4/6, metastatic melanoma, BRAF, V600
Eligibility Criteria
Inclusion Criteria:
- locally advanced or metastatic melanoma
- confirmed BRAF V600 mutation
- patients naïve to a selective BRAF inhibitor
- fresh tumor biopsy at baseline, and patient agrees for a mandatory biopsy at the time of relapse
- life expectancy ≥ 3 months
- World Health Organization (WHO) Performance Status ≤ 2.
Exclusion Criteria:
- Previous treatment with RAF-inhibitor
- Symptomatic or untreated leptomeningeal disease
- Symptomatic brain metastases.
- Known acute or chronic pancreatitis
- Clinically significant cardiac disease
- AST/SGOT and ALT/SGPT > 2.5 x ULN, or > 5 x ULN if liver metastases are present
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral interventional drug
- Previous or concurrent malignancy.
- Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
Specific exclusion criteria for each treatment arm:
LGX818/MEK162:
History or current evidence of retinal disease History of Gilbert's syndrome.
LGX818/BKM120:
Patients with diabetes mellitus requiring insulin treatment Patient has mood disorders
LGX818/BGJ398:
History and/or current evidence of ectopic mineralization/ calcification Current evidence of corneal disorder/ keratopathy Patients with current evidence of endocrine alteration of calcium/phosphate homeostasis.
History of congenital long QT- syndrome and/or hypokalaemia CTCAE Grade ≥ 3 and/or magnesium levels below the clinically relevant lower limits before study entry.
Ionized (i) calcium (Ca) > ULN Serum inorganic phosphorus (Pi) > ULN
LGX818/LEE011 History of congenital long QT- syndrome and/or hypokalaemia CTCAE Grade ≥ 3 and/or magnesium levels below the clinically relevant lower limits before study entry.
Sites / Locations
- Sarah Cannon Research Institute Onc Dept
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Experimental
LGX818 single agent
Patients had to have written documentation of a BRAFV600 mutation, which was to have been obtained locally on a fresh tumor biopsy (preferred) or on the most recent archival tumor sample available.