[Correspondence] Go, no-go decision making for phase 3 clinical trials: ACT IV revisited

We read with great interest the Article by Michael Weller and colleagues1 and the Comment by Elizabeth R Gerstner2 regarding the negative phase 3 study of rindopepimut in newly diagnosed glioblastoma. Gerstner notes that the ACT IV trial did not confirm the previous results of three phase 2 studies (ACTIVATE, ACT II, and ACT III), which were compared with a historical control that served as the basis for the phase 3 study. Her thoughtful speculation that temozolomide-induced lymphopenia or heterogeneity of EGFRvIII expression, or both,2 might provide a partial explanation of the failure of the ACT IV study.

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