ALLIANCE A031203 is a randomized phase II trial of cabozantinib versus sunitinib in patients with previously untreated metastatic renal cell cancer with intermediate/poor risk. These patients represent 80 percent of all patients and those who will likely need systemic therapy. The primary objective of this study is to compare PFS in patients treated with cabozantinib versus patients treated with sunitinib. At the time of progression, patients’ treatment will be unblinded and those who had been receiving sunitinib will be permitted to crossover to cabozantinib.
Secondary objectives are two-fold: 1) to compare the ORR of patients treated with cabozantinib versus patients treated with sunitinib, and 2) to evaluate whether patients treated with cabozantinib have improved OS when compared with patients treated with sunitinib.
Eligible patients must have histologically confirmed RCC with clear cell components. Patients must meet intermediate/poor risk criteria, have measurable disease as indicated by RECIST criteria and should be untreated with systemic agents. Adequate bone marrow, cardiac, renal, and hepatic function will be required, and patients with active malignancies other than renal cell carcinoma will be ineligible.
About 140 people will take part in this study, which includes one correlative study, Alliance A031203-ST1. The correlative science study objectives are to determine whether patients with tumors having high MET expression by immunohistochemistry (IHC) have an improvement in PFS compared to patients with tumors exhibiting low MET expression on both arms of this study. There currently are no prognostic biomarkers for treatment with MET inhibitors.
The study protocol for ALLIANCE A031203 is currently in development and it is projected to be activated in April 2013.
The Study Chair is Toni K. Choueiri, MD, of the Dana-Farber Cancer Institute, e-mail: firstname.lastname@example.org.
This trial is a big one. If Cabo can show an increase in OS it would be a win for the patients and EXEL. I would think an increase of 4 months min would be needed to get doctors to switch, but I would love to se 6-7 months (or more).