drugset / Trial / NCT02768207

A Study to Detect V-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF) V600 Mutation on Cell-Free Deoxyribonucleic Acid (cfDNA) From Plasma in Participants With Advanced Melanoma

NCT02768207

Phase 2 Completed 40 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelScreening

Summary

This is a single arm, multicenter, open label, and non-randomized clinical study on adult participants with unresectable or metastatic melanoma. The study will be conducted in two phases. Pre-screening phase will assess the BRAF V600 mutation in a new mutation analysis triggered by a mutant plasma cfDNA test result. Treatment phase will assess the clinical outcome for the participants treated with vemurafenib plus cobimetinib. The length of the study will be approximately 38 months.

Timeline

Start
2016-05-23
Primary completion
2017-12-20
Completion
2019-06-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Cobimetinib Small molecule 60 mg Oral
Subject Vemurafenib Small molecule 960 mg Oral

Indications