Table 2

Phase II clinical trials for patients with EOC with DC vaccines pulsed tumor P/PA antigens

Study phase and designPatient numberDC vaccine methodControl armPrimary endpointsSecondary endpointsTrial ID/Ref.
Open label, randomized, parallel assignment,
phase IIb
56DC pulsed with MUC1 (CVac)PlaceboMedian PFS: 13 vs 9 months (HR)=0.73, p=0.36)
CR1 subgroup: median PFS 13 vs 18 months (HR=1.18; CI 0.52 to 2.71, p=0.69). CR2 subgroup: median PFS: >13 vs 5 months (HR=0.32, p=0.04)
CR2 subgroup: median OS: >42 vs 26 months (HR=0.17; CI 0.02 to 1.4, p=0.07).
TEAEs>grade 3: 12.5%
NCT01068509/23
Single-arm, open-label,
phase II
28DC pulsed with MUC1 (CVac)NoCA125 response or stabilization: 15%AEs>grade 3: 0 22
Open label, parallel assignment, phase II21Arm a: P53 peptides, intravenous
Arm b: DC pulsed
P53 peptides, SC
NoImmunologic response:
Arm a vs Arm b=69% vs 83%
Median PFS: 4.2 vs 8.7 months;
Median OS: 40.8 vs 29.6 months:
AEs>grade 3: 0, 0 for both
25
Single-arm, open-label,
phase II
56DC pulsed with MUC1, WT-1 peptides, intravenousNoImmunologic response: 71%.
Median OS:30.4 months
AEs>grade 3: 0 24
  • AEs, incidence of adverse events; CR1, first clinical remission; CR2, second clinical remission; DC, dendritic cell; EOC, epithelial ovarian cancer; MUC1, Mucin 1; OS, overall survival; PFS, progression-free survival; P/PA, peptide/protein; Ref, Reference; SC, subcutaneous; TEAEs, treatment emergent adverse events; WT1, Wilms' tumor protein 1.