Autologous dendritic cell vaccination (DCVAC/OvCa) added to standard of care therapy in three open-label randomized phase 2 studies in women with advanced stage ovarian cancer (OC).
ABSTRACT
Background: OC is the 5th most common type of cancer in women and the 4thmost common cause of cancer death in women. Immunotherapy, for induction of tumor cell specific immune responses destroying tumor cells, has emerged as a promising treatment modality in solid malignant tumors. Studies have shown that chemotherapy can be combined with vaccine without blunting the response to the vaccine.
Methods: The approach tested in the reported trials is a patient specific active cellular immunotherapy using autologous dendritic cells differentiated from peripheral blood monocytes and presenting tumor antigens derived from killed OC cell lines (SK-OV-3, OV-90). A phase 1 trial of DCVAC/OvCa (EudraCT 2010-021462-30) was the basis for the phase 2 program. This includes 3 protocols designed for patients with 1stline treatment, relapsed Pt-sensitive and relapsed Pt-resistant advanced stage OC. Immunotherapy is added to standard chemotherapy. SOV01 (90 pts; EudraCT 2013-001322-26): A randomized, open-label, three-arm, multi-center Phase II clinical trial evaluating effect of addition of DCVAC/OvCa to first line standard chemotherapy (carboplatin and paclitaxel) in women with newly diagnosed epithelial ovarian carcinoma. SOV02 (60 pts; EudraCT 2013-001323-38): A randomized, open-label, parallel group, multi-center Phase II clinical trial evaluating effect of addition of DCVAC/OvCa to standard chemotherapy (carboplatin and gemcitabine) in women with relapsed platinum sensitive epithelial ovarian carcinoma. SOV03 (60 pts; EudraCT 2013-001325-24): A randomized, open-label, parallel group, multi-center Phase II clinical trial evaluating effect of addition of DCVAC/OvCa to standard chemotherapy in women with relapsed platinum resistant epithelial ovarian carcinoma. The first patient in the phase 2 program was enrolled November 5, 2013, and all 3 trials are now recruiting patients. As of February 3, 10 patients had been screened and 7 had been randomized. Clinical trial information: EudraCT 2013-001322-26 (plus others see abstract).