NCT02263898

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Recurrent Melanoma
• Stage IV Melanoma

Interventions

Type	Name	Description
DRUG	Raf kinase inhibitor LGX818	Given PO
DRUG	binimetinib	Given PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2015-01-01
• Primary completion: 2019-12-01
• Completion: 2020-12-01
• First posted: 2014-10-13
• Last updated: 2020-07-27

Locations

1 site across 1 country: United States