PART 4 SUMMARY OF EVIDENCE – Provide an overview of all key journal articles or research published in the public domain related to the proposed service that is for your application (limiting these to the English language only). Please do not attach full text articles, this is just intended to be a summary. Type of study of journal article or Short description of research (max 50 words)** Website link to Date of design* research project (including journal article or any trial identifier or study research (if available) * lead if relevant) 1. Phase III, Adjuvant dabrafenib plus The trial sought to determine whether the combination of September 10 Randomised trametinib in stage III dabrafenib and trametinib would improve relapse-free survival, 2017 controlled trial melanoma overall survival and freedom from relapse in patients with Stage III melanoma with BRAF V600E or BRAF V600K mutations after The pivotal trial upon which complete resection. this publication is based is known COMBI-AD trial. The study is ongoing, but is not recruiting. 870 patients underwent randomisation. NCT01682083 Primary investigator- Georgina Long Categorise design, for example meta-analysis, randomised trials, non-randomised or observational study, study of diagnostic accuracy, etc. **Provide high information including population numbers and whether patients are being recruited or in post-recruitment, including providing the trial registration number to allow for tracking purposes. *** If the publication is a follow-up to an initial publication, please advise.
PART 4 – SUMMARY OF EVIDENCE Provide an overview of all key journal articles or research published in the public domain related to the proposed service that is for your application (limiting these to the English language only). Please do not attach full text articles, this is just intended to be a summary. Type of study design* of journal article or research project (including any trial identifier or study lead if relevant) Short description of research (max 50 words)** Website link to journal article or research (if available) Date of 1. Phase III, Randomised controlled trial Adjuvant dabrafenib plus trametinib in stage III melanoma The pivotal trial upon which this publication is based is known COMBI-AD trial. NCT01682083 Primary investigator- Georgina Long The trial sought to determine whether the combination of dabrafenib and trametinib would improve relapse-free survival, overall survival and freedom from relapse in patients with Stage III melanoma with BRAF V600E or BRAF V600K mutations after complete resection. The study is ongoing, but is not recruiting. 870 patients underwent randomisation. September 10 2017 * Categorise design, for example meta-analysis, randomised trials, non-randomised or observational study, study of diagnostic accuracy, etc. **Provide high information including population numbers and whether patients are being recruited or in post-recruitment, including providing the trial registration number to allow for tracking purposes. *** If the publication is a follow-up to an initial publication, please advise.
MSAC_Application_form_BRAF_test_Accessible_redacted.docx