Argos Therapeutics Inc. announced that the Independent Data Monitoring Committee (IDMC) for the company’s pivotal Phase 3 ADAPT clinical trial of rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of metastatic renal cell carcinoma (mRCC) has recommended that the study be discontinued for futility based on its planned interim data analysis. The IDMC concluded that the study was unlikely to demonstrate a statistically significant improvement in overall survival in the combination treatment arm, utilizing the intent-to-treat population, the primary endpoint of the study. The IDMC noted that rocapuldencel-T was generally well-tolerated in the trial. In conjunction with its clinical and scientific advisors, the company is analyzing the preliminary ADAPT trial data set and plans to discuss the data with the U.S. Food and Drug Administration (FDA).  The company plans to leave the ADAPT trial open while the company conducts its ongoing data review and discussions with FDA. Based on these analyses and discussions, the company will make a determination as to the next steps for the rocapuldencel-T clinical program. The randomized Phase 3 ADAPT trial evaluating rocapuldencel-T plus sunitinib/standard-of-care therapy versus standard-of-care therapy alone in newly diagnosed mRCC patients was opened in January 2013 and completed enrollment in July 2015.  A total of 462 mRCC patients were randomized to the trial. The primary endpoint of the trial is a statistically significant improvement in overall survival.