A Randomized, Open-label, Three-arm, Multi-center Phase II Trial of Addition of DCVAC/OvCa to First Line Standard Chemotherapy in Women With Newly Diagnosed Epithelial Ovarian Carcinoma

Trial ID #	NCT02107937; SOVO1
Phase	II
Drug Class	Immunotherapy: Vaccine/TAA
Drug Name	DCVAC/OvCa
Alternate Drug Names	ovarian tumor antigen-activated autologous dendritic cell vaccine
Drugs in Trial	DCVAC/OvCa
Eligible Participant	Newly diagnosed stage III ovarian cancer with optimal debulking (< 1 cm residual disease)
Patients Enrolled	99
Therapy Setting	First-line, Maintenance
Study Design	Open-Label, Randomized
Endpoints	PFS, evaluated per RECIST
Efficacy	DCVAC concomitant with Chemo (n=31) vs DCVAC sequential after chemo (n=29) vs chemo alone (n=30): PFS: 20.3 vs NR vs 21.4 months, HR: 0.98 (0.48-2.00), HR: 0.39 (0.16-0.96, p=0.034)
Clinically Significant Adverse Events	DCVAC concomitant with Chemo (n=31) vs DCVAC sequential after chemo (n=29) vs chemo alone (n=30):
Conclusion	DCVAC/OvCa sequential to chemo is associated with a statistically significant improvement in PFS in patients undergoing first-line treatment
Reference	Rob L et al. Safety and efficacy of dendritic cell-based immunotherapy DCVAC/OvCa added to first-line chemotherapy (carboplatin plus paclitaxel) for epithelial ovarian cancer: a phase 2, open-label, multicenter, randomized trial. J Immunother Cancer (2022) 10(1):e003190 https://pubmed.ncbi.nlm.nih.gov/34992091/