MAIN-CAV: Phase III Randomized Trial of Maintenance Cabozantinib and Avelumab vs Maintenance Avelumab After First-Line Platinum-Based Chemotherapy in Patients With Metastatic Urothelial Cancer
Objective
Primary objective: To evaluate the effect of cabozantinib in combination with avelumab on OS compared to avelumab alone in patients with mUC who did not progress during first-line platinum-based chemotherapy therapy, i.e. patients who had CR, PR or SD after completion of first line platinum-based chemotherapy.
Secondary Objectives: To evaluate the effect of cabozantinib in combination with avelumab on progression-free survival (PFS) compared to avelumab alone for maintenance treatment following initial first-line treatment in patients who had a CR, PR or SD upon completion of first-line platinum-based chemotherapy. To evaluate the safety and tolerability of cabozantinib in combination with avelumab in mUC compared to avelumab alone for maintenance treatment following initial first-line treatment in patients who had a CR, PR or SD upon completion of first-line platinumbased chemotherapy. To evaluate activity of cabozantinib in combination with avelumab based on RECIST compared to avelumab alone for maintenance treatment following initial first-line treatment in patients who had a CR, PR or SD upon completion of first-line platinumbased chemotherapy. Results of the primary analysis will be examined for consistency, while accounting for the stratification factors and/or covariates of baseline QOL and fatigue. To evaluate the activity of cabozantinib in combination with avelumab compared to avelumab alone based on PD-L1 status of patients tumors.
