Phase II randomized trial of autologous tumor lysate dendritic cell vaccine (ADC) plus best supportive care (BSC) compared with BSC, in pre-treated advanced colorectal cancer patients.

3048 Background: No treatments are available for patients (pts) with metastatic colorectal cancer (mCRC) that progresses after all approved therapies. Autologous tumor lysate dendritic cell vaccine (ADC) has T-cell stimulatory capacity and therefore potential antitumor activity. We designed a phase II randomized trial of ADC plus BSC (arm A) compared with BSC (arm B), in pre-treated mCRC patients. Methods: Pts with documented mCRC and progressive disease at least to two chemotherapy regimens and ECOG performance status (PS) of 0-2, were randomized (1:1 ratio) to arm A vs B. Stratification was done by ECOG PS (0,1 vs 2) and LDH ( ULN). Arm A was administered subcutaneously days 0,10,20,40,120 and thereafter every 6 months (m) till progressive disease (PD). Radiological evaluation was planned with multidetector computed tomography (MDCT) every 2 m the first 6 m and then every 3 m till PD in both arms. Primary endpoint was progression free rate (PFR) at 4 m. Accordingly, sample size was establishe...