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 5^th most common type of cancer in women and the 4^thmost 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 1^stline 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).

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Citation:
J Clin Oncol 32:5s, 2014 (suppl; abstr TPS3134)