Table 1

Phase II/III clinical trials for patients with EOC by DC vaccines pulsed with whole tumor cell antigens

Study phase and designPatient numberDC vaccine treatmentControl armPrimary endpointsSecondary endpointsTrial ID/Ref.
Multicenter, double-blind, randomized, placebo-controlled, phase III678Stage I: Placebo+carboplatin and gemcitabine or carboplatin and paclitaxel
Stage II: Placebo+bevacizumab or PARPi
OSPFS, ORR, DOR, TEAEsNCT03905902/21
SOV02 : randomized, open-label, parallel-group, multicenter phase II64DC pulsed with tumor cell lysate (DCVAC/OvCa)Carboplatin and gemcitabineMedian OS: 35.5 vs 22.3 months (HR=0.38 p=0.0032)Median PFS: 11.3 vs 9.5 months21
Single-arm, open-label, multicenter, phase II30DC pulsed with tumor cell lysate (DCVAC/OvCa)NoPFSOS, ORR, DOR, AEs,NCT03657966
Single-arm, open-label,
phase II
36DC pulsed with tumor cell lysate or WT1 and MUC1 peptideNoORRTAEsNCT00703105
Open label, randomized, parallel assignment, phase II23DC pulsed with tumor cell lysateNoCellular immunity TAEs, ORRNCT00799110
Multicenter, double-blind, randomized, placebo-controlled, phase II99DC pulsed with tumor cell lysate (AVOVA-1)MC+GM-CSFOSPFSNCT02033616
Single-arm, open-label,
phase I/IIa
18Alpha-DC1 vaccineNoAEs>grade 3, Immunologic responses,ORR, OS, PFSNCT03735589
Open label, randomized, parallel assignment, phase II25DC vaccineNoAEs>grade 3, Immunologic responseNCT02432378
  • AEs, Incidence of adverse events; DC, dendritic cell; DOR, duration of response; EOC, epithelial ovarian cancer; GM-CSF, granulocyte-macrophage colony-stimulating factor; MC, monocytes cell; MUC1, Mucin 1; ORR, objective response rate; OS, Overall survival; PARP, Poly ADP-ribose Polymerase; PFS, progression-free survival; Ref, Reference; TAEs, toxicities of adverse events; TEAEs, treatment emergent adverse events; WT1, Wilms' tumor protein 1.