Vemurafenib in metastatic melanoma patients with brain metastasis

• Research type

  Research Study

• Full title

  AN OPEN-LABEL, SINGLE-ARM, PHASE II, MULTICENTER STUDY TO EVALUATE THE EFFICACY OF VEMURAFENIB IN METASTATIC MELANOMA PATIENTS WITH BRAIN METASTASES

• IRAS ID

  82685

• Eudract number

  2011-000954-46

• ISRCTN Number

  N/A

• Research summary

  Melanoma is the third most common tumor to metastasise (spread) to the brain, after lung and breast cancer. Current management strategies for melanoma brain metastases are ineffective, as brain metastases contribute to death in nearly 95% of patients with known brain involvement. The median survival of patients is only 2-3 months and the few long-term survivors are only from those patients who have limited disease that can be tackled surgically or with high doses of radiotherapy. Brain metastases are associated with progressive neurological deterioration and have a tremendous impact on quality of life. An extraordinary clinical need therefore exits for new treatments in patients with melanoma brain metastases.Vemurafenib is a highly selective inhibitor of an oncogene, the BRAF kinase, that has been identified in approximately 50% of malignant melanomas. Results from past trials have shown that vemurafenib induces high response rates (>40%) in patients with metastatic melanoma carrying the BRAF mutation. Recent data has also confirmed a significant survival benefit with vemurafenib treatment compared with standard chemotherapy in patients with metastatic melanoma. Vemurafenib's common side effects include joint pains, rash, tiredness, rash, skin sensitivity to sunshine, nausea and diarrhoea. Some patients develop small skin growths that are easily removed.The biochemical specificity and high activity of vemurafenib in past trials, coupled with the high clinical need for new melanoma brain metastases treatments, makes it of significant clinical importance to assess whether vemurafenib is effective and well tolerated in this patient population.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  11/SC/0272

• Date of REC Opinion

  4 Aug 2011

• REC opinion

  Further Information Favourable Opinion