Safety and Efficacy of LEE011 and LGX818 in Patients With BRAF Mutant Melanoma.

Inclusion Criteria:

- Age ≥18 years.

- Diagnosis of locally advanced or metastatic melanoma along with written documentation
of BRAF V600 mutation.

- ECOG performance status of 0 - 2.

- Patients enrolled into Phase Ib must have evidence of evaluable and/or measurable
disease as determined by RECIST v1.1.

- Patients enrolled into Phase II (BRAFi naïve and resistant) must have evidence of
measurable disease as determined by RECIST v1.1.

- Archival tumor tissue must be obtained for patients enrolled in Phase Ib and Phase II
arm 1a/b- BRAFi naïve patients. If an archival tumor tissue is not available, a fresh
tumor sample is acceptable.

- For patients enrolled in the phase II arm 2, patients must agree to undergo a fresh
tumor biopsy unless one was collected prior to study entry but at the time of disease
relapse from the most recent BRAFi treatment.

Exclusion Criteria:

- Symptomatic brain metastases.

- Symptomatic or untreated leptomeningeal disease.

- Patients with inadequate laboratory values during screening.

- In the phase II BRAFi naïve arms (1a/b), prior exposure to CDK4/6 inhibitor (e.g., PD
0332991)

- Impaired cardiac function or clinically significant cardiac diseases.

- Impairment of gastro-intestinal (GI) function or GI disease that may significantly
alter the absorption of LEE011 or LGX818.

- Patients with concurrent severe and/or uncontrolled concurrent medical conditions.

- Previous or concurrent malignancy.

- Major surgery < 2 weeks before starting study treatment

- Known diagnosis of human immunodeficiency virus (HIV) or hepatitis C.

Other protocol-defined inclusion/exclusion criteria may apply.