NCT02094872

Molecularly Targeted Therapy in Treating Patients With BRAF Wild-type Melanoma That is Metastatic

Stand Up to Cancer Consortium Genomics-Enabled Medicine for Melanoma (G.E.M.M.): Using Molecularly-Guided Therapy for Patients With BRAF Wild-Type (BRAFwt) Metastatic Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well molecularly targeted therapy works in treating patients with melanoma that has spread to other parts of the body. Patients must have received or do not qualify for prior immunotherapy. Targeted therapy is a type of treatment that uses drugs or other substances to identify and attack specific types of cancer cells with less harm to normal cells. Molecularly targeted therapy works by treating patients with substances that kill cancer cells by targeting key molecules involved in cancer cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To determine the difference in best overall response rate (BORR) between patients treated with MEK162 following personalized molecularly guided assignment vs. a historical BORR of 7% in this patient population. SECONDARY OBJECTIVES: I. To evaluate the safety of performing individualized drug therapy (including novel agents and commercially-available agents) in the context of a personalized medicine clinical trial. II. To define the difference in progression free survival (PFS) between patients treated with MEK162 following personalized molecularly guided assignment vs. a historical PFS rate of 2 months in this patient population. III. To continually assess data in real time so as to iteratively refine and standardize a set of statistical and informatics methodologies for matching treatments to the patient's tumor, based on the molecular profile. OUTLINE: Patients undergo collection of tissue and blood samples for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) analysis via sequencing. Based on the results of the DNA and RNA analysis, patients receive molecularly targeted therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

Conditions

• Recurrent Melanoma
• Stage IIIA Melanoma
• Stage IIIB Melanoma
• Stage IIIC Melanoma
• Stage IV Melanoma

Interventions

Type	Name	Description
OTHER	cytology specimen collection procedure	Undergo collection of tissue and blood samples
DRUG	MEK 162 therapy or molecularly targeted therapy	molecularly targeted therapy, MEK 162 therapy
PROCEDURE	therapeutic procedure
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	quality-of-life assessment	Ancillary studies

Timeline

• Start date: 2014-05-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2014-03-24
• Last updated: 2020-01-02
• Results posted: 2020-01-02

Locations

8 sites across 1 country: United States