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A Phase Ib/II, Mulicenter, Study of LEE011 in Combination With LGX818 in Adult Patients With BRAF Mutant Melanoma.

Phase 1/Phase 2
18 Years
Not Enrolling
Locally Advanced or Metastatic BRAF Mutant Melanoma

Thank you

Trial Information

A Phase Ib/II, Mulicenter, Study of LEE011 in Combination With LGX818 in Adult 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Dose Limiting Toxicities (Phase Ib)

Outcome Description:

Dose Limiting Toxicities (DLTs) during the first 28 days of the combination treatment of LEE011 and LGX818.

Outcome Time Frame:

Cycle 1 = 28 days

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

May 2013

Completion Date:

December 2015

Related Keywords:

  • Locally Advanced or Metastatic BRAF Mutant Melanoma
  • Open-label dose escalation; BRAF inhibitor; LEE011; CDK4/6; LGX818; RAF kinase inhibitor; metastatic melanoma; BRAF; V600
  • Melanoma



Cancer Centers of the Carolinas CCC Faris Greenville, South Carolina  29605
Oregon Health & Science University Dept. of OHSU (3) Portland, Oregon  97239
Northwestern University Clinical Research Office (2) Chicago, Illinois  60611
University of California at Los Angeles UCLA 3 Los Angeles, California  90095
University of Colorado Dept of Oncology Aurora, Colorado  80045
Memorial Sloan Kettering Cancer Center Dept Oncology New York, New York  10021
Duke University Medical Center SC-6 Durham, North Carolina  27710
Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State University Columbus, Ohio  43210
University of California San Diego Dept of Onc La Jolla, California  92093-0658
Yale University School of Medicine dept of Onc New Haven, Connecticut  06520
Cancer Centers of Florida PA Cancer Centers of South Florid Ocoee, Florida  *see dep*
Dartmouth Hitchcock Medical Center Dept Onc Lebanon, New Hampshire  03756
Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research Dept of Oncology Seattle, Washington  98109-1023