A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial DCVAC/OvCa Added to Standard Chemotherapy in Women With Relapsed Platinum Sensitive Epithelial Ovarian Carcinoma

Trial ID #	NCT02107950; SOVO2
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	Carboplatin, DCVAC/OvCa, Gemcitabine
Eligible Participant	Platinum sensitive ovarian cancer at first recurrence
Patients Enrolled	71
Therapy Setting	Recurrence
Study Design	Open-Label, Randomized
Endpoints	PFS, OS, evaluated per RECIST
Efficacy	Carbo+Gem+DCVAC/OvCa (n=32) vs Carbo+Gem (n=32): PFS: 11.3 vs 10.1 months, HR: 0.73 (0.42-1.28, p=0.27) OS: 35.5 vs. 22.1 months, HR, 0.38 (0.20-0.74, p=0.0032)
Conclusion	Significantly prolonged OS with addition of DCVAC/OvCa to carboplatin+gemcitabine
Reference	Cibula D et al. Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial. Gynecol Oncol (2021) 162(3):652-660 https://pubmed.ncbi.nlm.nih.gov/34294416/