Clinical Trial VICCMEL1325
A Phase IB/II, Multicenter, Study of LEE011 in Combination with LGX818 in Adult Patients with BRAF mutant melanoma
- Protocol No. VICCMEL1325
- Open Date: 09/25/2013
- Staging: Phase I/II
- Age Group: Adults
- Scope: National
- Objective: Phase Ib: To estimate the MTD(s) and/or determine the RP2D of oral LEE011 in combination with oral LGX818 in patients with BRAF mutant melanoma. Phase II, Part 1: To assess the anti-tumor activity of LEE011 in combination with LGX818 vs. LGX818 alone in patients with metastatic BRAF mutant melanoma who are naive to poor selective BRAFi treatment. Phase II, Part 2: To assess the anti-tumor activity of LEE011 in combination with LGX818 in patients with metastatic BRAF mutant melanoma who are resistant to prior selective BRAFi treatment
- Disease Sites: Melanoma
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: LEE011; LGX818
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01777776
- Secondary Protocol No: CLEE011X2105
Participants are being asked to take part in this study to find out if the study drugs LEE011 and LGX818 are safe and have beneficial effects in patients with melanoma (skin cancer), who have a specific change (also called mutation) in a gene called BRAF. The purpose of this study is to study the safety and effects of LEE011 with LGX818 in treating patients with melanoma, the highest safe dose of LEE011 with LGX818, how a participant-s body absorbs and handles the combination of drugs, and substances found in the tissue (biomarkers) that may indicate the effects or progress of the disease and the activity of LEE011 with LGX818.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• 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.
• 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.