• Duration of Response (DoR). DoR is defined as the interval between the date of earliest determination of CR or PR to the date of earliest determination of PD, or to the date of death, if PD does not occur. • Disease Control rate (D CR). DCR is defined as the p ercenta ge of subjects mee ting criteria of S table Dise ase (SD), PR, or CR ove r a period of at lea st 4 we eks. • Progressive Free Survival (P FS) at 8 and 24 weeks. PFS is defi ned as the inte rval between t he date of first dose to the date of e arliest determinat ion of Progre ssive D isease Sponsor: Ludwig Institute for Cancer Research. Protocol Number: LUD2014- 012-VAC.