Dendritic cell vaccine (DCVAC) with chemotherapy (ct) in patients (pts) with recurrent epithelial ovarian carcinoma (EOC) after complete response (CR) to 1st-line platinum (Pt)-based ct: Primary analysis of a phase 2, open-label, randomized, multicenter trial.

e17515Background: When pts with EOC relapse, their response to subsequent therapy is reduced. We hypothesized that autologous DCVAC could potentiate the antitumor response to ct and delay progression. Methods: Key eligibility criteria were FIGO stage III - IV EOC (serous, endometrioid, or mucinous), PS 0 - 2, CR after 1st-line Pt-based ct that lasted > 6 months, and at least 1 measurable lesion per RECISTv1.1. We randomized pts up to 6 weeks after relapse was confirmed by CT/MRI, 1:1, into arm A (A; DCVAC concomitantly with ct) and arm B (B; ct alone). Pts were stratified by previous bevacizumab use (yes/no) and duration of remission (6 - 12/ > 12 months). Ct consisted of 6 - 10 cycles of carboplatin (AUC 4 - 5; D1) and gemcitabine (1000mg/m2; D1, D8). Pts in A were to receive 10 doses of DCVAC (1 x 107 DCs/dose). The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), and safety. Results: Between No...