A Phase Ib/II Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF Dependent Advanced Solid Tumors

Inclusion Criteria:

Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer [AJCC]), or confirmed diagnosis of non-resectable advanced metastatic colorectal cancer (mCRC), or any other indication upon agreement with the Sponsor, whose disease has progressed despite previous antineoplastic therapy or for whom no further effective standard therapy is available

Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation
Evidence of measurable disease as determined by RECIST v1.1
World Health Organization (WHO) Performance Status ≤ 2
Negative serum pregnancy test within 72 hours prior to the first study dose in all women of childbearing potential

Exclusion Criteria:

Progressive disease following prior treatment with RAF-inhibitors in combination with MEK-inhibitors

Symptomatic or untreated leptomeningeal disease
Symptomatic brain metastases. Patients are not permitted to receive enzyme inducing anti-epileptic drugs
Known acute or chronic pancreatitis
History or current evidence of retinal disease, retinal vein occlusion or ophthalmopathy
Clinically significant cardiac disease
Patients with abnormal laboratory values at Screening/baseline
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LGX818/MEK162
Previous or concurrent malignancy
Pregnant or nursing (lactating) women
For addition of LEE011 in the triple combination, congenital long QT syndrome or family history of unexpected sudden cardiac death and/or hypokalemia CTCAE Grade ≥ 3, brain metastases at baseline, abnormal coagulation results PT/INR >1.5 x ULN or aPTT >1.5 x ULN.

Other protocol-defined inclusion/exclusion criteria may apply