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
Phase II
Drug Class Immunotherapy: Vaccine
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: 0.77 (0.44-1.35, p=0.35)
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) with chemotherapy in patients with platinum-sensitive, relapsed, epithelial ovarian carcinoma: Survival analysis of a phase II, open-label, randomized, multicenter trial (study SOVO2). SGO (2019) abstract 35
https://www.onclive.com/conference-coverage/sgo-2019/addition-of-dendritic-cell-based-immunotherapy-to-chemo-improves-os-in-relapsed-ovarian-cancer