GO27826 Phase III Adjuvant Therapy in BRAF Mutant Melanoma

• Research type

  Research Study

• Full title

  A PHASE III, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED STUDY OF VEMURAFENIB (RO5185426) ADJUVANT THERAPY IN PATIENTS WITH SURGICALLY RESECTED, CUTANEOUS BRAF-MUTANT MELANOMA AT HIGH RISK FOR RECURRENCE

• IRAS ID

  108307

• Contact name

  Mark Middleton

• Sponsor organisation

  F.Hoffmann-La Roche Ltd/Roche Global Development

• Eudract number

  2011-004011-24

• Research summary

  This study aims to find out whether the drug vemurafenib can help prevent or delay the return of melanoma that is at a high risk of returning (Stage IIC, IIIA, IIIB or IIIC) after surgical removal. It will assess whether vemurafenib causes side effects in patients, how it is processed by the body and look at the effect on proteins (biomarkers) in the blood, tumour or skin to provide information on response to treatment. Genes contain information to make protein. A large number of melanoma tumours have changes (mutations) in the BRAF gene. Vemurafenib works by preventing these changed BRAF proteins from working and therefore blocks the growth and spread of cancer cells. Approximately 725 patients will be enrolled in two groups. All patients will have cutaneous melanoma which has been completely removed by surgery and BRAF gene mutation. Group 1 will have approximately 500 patients with Stage IIC, IIIA or IIIB cutaneous melanoma, Group 2 will have approximately 225 patients with Stage IIIC cutaneous melanoma. Eligible patients will be randomly assigned to receive either vemurafenib or placebo over a 52 week period. There is an equal chance of receiving either treatment. Placebo is an inactive substance that looks like vemurafenib. As this is a ??double-blind?? study neither the study doctors nor the patients will know whether vemurafenib or placebo has been assigned. Study drug will be given for a maximum of 52 weeks or until disease recurrence. Treatment cycles are 4 weeks. Study visits will occur on Days 1, 8, 15 and 22 of Cycle 1; Days 1 and 15 of Cycle 2; and on Day 1 of Cycles 3-13. All patients will be followed for melanoma recurrence for up to 5 years and for Overall survival for up to 7 years after the first dose of study drug.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  12/NW/0641

• Date of REC Opinion

  14 Sep 2012

• REC opinion

  Favourable Opinion