Wednesday, December 11, 2019 The MEC4 (Alliance A091201) trial, a Randomized Phase II Study Comparing the MET Inhibitor Cabozantinib to Temozolomide/Dacarbazine in Ocular Melanoma has permanently closed. This randomized phase II trial studies how well cabozantinib-s-malate works compared with temozolomide or dacarbazine in treating patients with melanoma of the eye (ocular melanoma) that has spread to other parts of the body and cannot be removed by surgery. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cabozantinib-s-malate works better than temozolomide or dacarbazine in treating patients with melanoma of the eye. Objectives: Primary Objective: Compare the progression-free survival rate at 4 months (PFS4) of patients with ocular melanoma treated with cabozantinib or temozolomide / dacarbazine. Secondary Objectives: Estimate the distribution of progression-free survival (PFS) times; Estimate the distribution of overall survival (OS) times; Estimate the confirmed response rate as determined by the RECIST criteria; Assess the safety of these agents by examining the toxicity profile; Correlate the response of MET molecular status. For more information please visit the the MEC4 CCTG trials page.
