Phase III Study of Vemurafenib and Metformin for Unresectable Stage IIIC and IV BRAF V600E Positive Melanoma

What this Trial Is About

Researchers are evaluating the safety and clinical activity of a combination treatment using Vemurafenib and Metformin for patients with unresectable Stage IIIC and Stage IV melanoma that is positive for the BRAF V600E mutation. This Phase III study aims to determine if the combined regimen has acceptable toxicity and improves objective response rates and survival outcomes in metastatic melanoma patients, based on earlier pre-clinical studies and a Phase I trial. The study involves two phases Phase I focuses on assessing the safety of Vemurafenib given orally at 960 mg daily combined with Metformin starting at 500 mg twice daily for two weeks, then increasing to 850 mg twice daily. Phase II will evaluate the clinical effectiveness of this combination. Treatment is given in 28-day cycles and continues until the disease progresses or unacceptable side effects occur. The safety profile is monitored throughout both phases. Participants will undergo evaluations including safety monitoring for severe side effects, tumor response assessments, and overall survival follow-up every 12 weeks for up to three years after the last dose. Laboratory tests, imaging to measure tumor size, and other assessments will be performed regularly during the study period, which is estimated to last about 60 months. The main outcome measured is the occurrence of severe adverse events, along with treatment effectiveness and overall survival.

A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients