SUAVE - Sunitinib versus dacarbazine in metastatic uveal melanoma

• Research type

  Research Study

• Full title

  A randomised phase II study of sunitinib versus dacarbazine in the treatment of patients with metastatic uveal melanoma

• IRAS ID

  42866

• Contact name

  Ernest Marshall

• Sponsor organisation

  Clatterbridge Centre for Oncology

• Eudract number

  2008-008794-55

• ISRCTN Number

  N/A

• Research summary

  Uveal melanoma is the most common primary cancer involving the eye and is characterised by an unpredictable clinical course and a tendency to metastasise (spread) late. Overall prognosis is significantly worse than for a different type of eye cancer known as 'cutaneous melanoma', with 5 and 15 year survival rates of 72% and 53%, respectively. Control of the primary cancer in the eye can be achieved using various radiotherapy techniques or removal of the affected eye. However, once control of the primary cancer in the eye is lost and the cancer has spread to other areas in the body, the disease is incurable. No adjuvant therapy has demonstrated any survival benefit but dacarbazine is the usual treatment for this patient group. The lack of activity noted to date using both chemotherapy (drugs) and immunotherapy (changing the activity of the immune system) point to an urgent need to investigate novel therapies in this disease. Sunitinib has recently demonstrated major benefits in advanced clear cell carcinoma of the kidney which has doubled the progression free survival period compared to standard therapy. This study plans to investigate whether sunitinib has the potential to increase the progression free survival patients with unresectable good performance metastatic uveal melanoma compared to chemotherapy with current standard treatment, dacarbazine

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  10/H0904/15

• Date of REC Opinion

  17 May 2010

• REC opinion

  Further Information Favourable Opinion