Intermittent LGX818 and MEK162 in Treating Patients With Metastatic Melanoma Who Have BRAFV600 Mutations

Recurrent Melanoma Clinical Trial

Official title: Biomarkers of Durable Response With Intermittent Therapy With LGX818 and MEK162 Combined Therapy in Patients With BRAF Mutant Metastatic Melanoma

Status Withdrawn

Clinical Trial Summary

This phase II trial studies intermittent dosing of BRAF inhibitor LGX818 (encorafenib) and MEK inhibitor MEK 162 (binimetinib) in treating patients with melanoma that has spread to other parts of the body (metastatic) and have a BRAF V600 mutation. LGX818 and MEK162 may stop the growth of tumor cells by blocking different enzymes needed for cell growth. Giving LGX818 and MEK162 with breaks between each course (intermittently) may help delay the time when tumors become resistant to the drugs.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. One year progression free survival (PFS) rate.

SECONDARY OBJECTIVES:

I. Obtain biopsy samples from patients treated with an intermittent schedule of LGX818 and MEK162 to study adaptive and acquired resistance as well as melanoma evolutionary patterns.

II. Study molecular changes of adaptive resistance and acquired resistance to LGX818 and MEK162 in circulating melanoma cells.

III. Study plasma samples for circulating deoxyribonucleic acid (DNA), microribonucleic acid (microRNA) and protein signatures of adaptive resistance and acquired resistance.

IV. Explore the median progression free survival and overall survival of patients receiving an intermittent schedule of LGX818 and MEK162.

OUTLINE:

Patients receive LGX818 orally (PO) once daily (QD) and MEK162 PO twice daily (BID) continuously for 8 weeks, followed by intermittent dosing in subsequent cycles (3 weeks off therapy, 5 weeks on therapy). Cycles repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 6 months thereafter. ;

Related Conditions & MeSH terms

• Melanoma
• Recurrent Melanoma
• Stage IV Melanoma

• NCT number: NCT02263898
• Study type: Interventional
• Source: Jonsson Comprehensive Cancer Center
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2015
• Completion date: December 2020