A Randomised Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma
124 eligible patients will be randomised to either Sunitinib or Dacarbazine treatment.
Participants will then attend 3-weekly clinic visits and undergo 12-weekly tumour assessment
(CT or MRI scan) until disease progression (according to RECIST 1.1) has been identified.
At progression, patients may crossover to the other study treatment and continue with
3-weekly clinic visits and 12-weekly imaging until second progression.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival
The primary outcome measure for this trial is the progression-free survival time measured from date of randomisation. For patients with evidence of progressive disease (as measured by CT scan, or MRI if necessary) or patients who have died from any cause, progression-free survival time will be calculated to date of progressive disease or date of death (whichever occurs first) and will be counted as events in the analysis. Patients still alive with no evidence of progression at the time of their last visit are censored at the time of the most recent information.
Once all patients have been followed up for at least 3 months
Clatterbridge Centre for Oncology NHS Foundation Trust
United Kingdom: Medicines and Healthcare Products Regulatory Agency