Argos Therapeutics (ARGS) Inactive

The ADAPT trial is a randomized, multicenter, open label trial comparing combination therapy with rocapuldencel-T and sunitinib (or another targeted therapy) to monotherapy with sunitinib (or another targeted therapy) for the treatment of newly diagnosed metastatic renal cell carcinoma (mRCC). A total of 462 previously untreated patients were enrolled in the ADAPT trial and randomized 2:1 between combination treatment with rocapuldencel-T and sunitinib (combination arm) vs. sunitinib monotherapy (control arm) after undergoing cytoreductive nephrectomy. For both arms, the protocol permits switching to other standard-of-care treatments for mRCC for reasons such as intolerance to therapy or disease progression. The original primary efficacy endpoint for the study is a statistically significant improvement in overall survival in the combination treatment utilizing the intent to treat population at the pre-specified number of 290 events (deaths). Secondary efficacy endpoints include progression-free survival, objective response rate and disease control rate, and an exploratory efficacy endpoint of immune response. We dosed the firstpatient in May 2013 and completed enrollment in July 2015 at 107 sites across North America, Europe and Israel.