An Open-Label, Randomized Phase II Trial of Personalized Peptide Vaccination in @entity1 with @entity150 that Progressed after XXXX -Based Chemotherapy.

@entity1 @entity137 @entity5 @entity2286 @entity150 @entity902 @entity1349
PURPOSE: The prognosis of @entity902 -based chemotherapy-resistant metastatic @entity150 remains poor. Personalized selection of the right peptides for each @entity1 could be a novel approach for a @entity5 vaccine to boost anticancer immunity. EXPERIMENTAL DESIGN: In this randomized, open-label, phase II study, @entity1 ages >= 18 years with progressive @entity150 after first-line @entity902 -based chemotherapy were randomly assigned (1:1) to receive personalized peptide vaccination ( @entity2286 ) plus best supportive care (BSC) or BSC. @entity2286 treatment used a maximum of four peptides chosen from 31 candidate peptides according to human leukocyte antigen types and peptide-reactive IgG titers, for 12 s.c. injections (8 injections, weekly; 4 injections, bi-weekly). The primary endpoint was progression-free survival (PFS). Secondary endpoints were @entity1349 ( @entity1349 ), immune response, and @entity137 . RESULTS: Eighty @entity1 were randomly assigned to receive either @entity2286 plus BSC (n = 39) or BSC (n = 41). No significant improvement in PFS was noted [HR, 0.7; 95% confidence interval (CI), 0.4-1.2, P = 0.17]. For the secondary endpoints, @entity2286 plus BSC significantly prolonged @entity1349 compared with BSC (HR, 0.58; 95% CI, 0.34-0.99, P = 0.049), with median @entity1349 of 7.9 months (95% CI, 3.5-12.0) in the @entity2286 plus BSC and 4.1 months (95% CI, 2.8-6.9) in the BSC. @entity2286 treatment was well tolerated, without serious adverse drug reactions. CONCLUSIONS: @entity2286 could not prolong PFS, but @entity1349 appeared to be improved with @entity137 and immune responses. Further large-scale, randomized trials are needed to confirm these results. Clin Cancer Res; 1-7.   2015 AACR.
