Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial
Language English Country United States Media print-electronic
Document type Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
34294416
DOI
10.1016/j.ygyno.2021.07.003
PII: S0090-8258(21)00533-3
Knihovny.cz E-resources
- Keywords
- Dendritic-cell based immunotherapy, Immunogenic cell death, Ovarian cancer,
- MeSH
- Dendritic Cells immunology transplantation MeSH
- Deoxycytidine administration & dosage analogs & derivatives MeSH
- Adult MeSH
- Carcinoma, Ovarian Epithelial therapy MeSH
- Gemcitabine MeSH
- Immunotherapy, Adoptive adverse effects methods MeSH
- Carboplatin administration & dosage MeSH
- Combined Modality Therapy MeSH
- Middle Aged MeSH
- Humans MeSH
- Ovarian Neoplasms drug therapy immunology pathology therapy MeSH
- Antineoplastic Combined Chemotherapy Protocols adverse effects therapeutic use MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Neoplasm Staging MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase II MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Deoxycytidine MeSH
- Gemcitabine MeSH
- Carboplatin MeSH
OBJECTIVE: DCVAC/OvCa is an active cellular immunotherapy designed to stimulate an immune response against ovarian cancer. We explored the safety and efficacy of DCVAC/OvCa plus carboplatin and gemcitabine in platinum-sensitive ovarian cancer. METHODS: In this open-label, parallel-group, phase 2 trial (ClinicalTrials.gov number NCT02107950), patients with platinum-sensitive ovarian cancer relapsing after first-line chemotherapy were randomized to DCVAC/OvCa and chemotherapy or chemotherapy alone. DCVAC/OvCa was administered every 3-6 weeks (10 doses). Endpoints included safety, progression-free survival (PFS; primary efficacy endpoint) and overall survival (OS; secondary efficacy endpoint). RESULTS: Between November 2013 and May 2015, 71 patients were randomized to chemotherapy in combination with DCVAC/OvCa or to chemotherapy alone. Treatment-emergent adverse events related to DCVAC/OvCa, leukapheresis and chemotherapy occurred in six (16.2%), two (5.4%), and 35 (94.6%) patients in the DCVAC/OvCa group. Chemotherapy-related events occurred in all patients in the chemotherapy group. Seven patients in the DCVAC/OvCa group were excluded from primary efficacy analyses due to failure to receive ≥1 dose of DCVAC/OvCa. PFS was not improved (hazard ratio [HR] 0.73, 95% confidence interval [CI] 0.42-1.28, P = 0.274, data maturity 78.1%). Median OS was significantly prolonged (by 13.4 months) in the DCVAC/OvCa group (HR 0.38, 95% CI 0.20-0.74, P = 0.003; data maturity 56.3%). A signal for enhanced surrogate antigen-specific T-cell activity was seen with DCVAC/OvCa. CONCLUSIONS: DCVAC/OvCa combined with chemotherapy had a favorable safety profile in patients with platinum-sensitive ovarian cancer. DCVAC/OvCa did not improve PFS, but the exploratory analyses revealed OS prolongation and enhanced surrogate antigen-specific T-cell activity.
Jagiellonian University Hospital Jakubowskiego 2 30 688 Krakow Poland
Masaryk Memorial Cancer Institute Zluty kopec 7 653 53 Brno Czech Republic
Medical University of Bialystok 24a M Sklodowskiej Curie Str 15 276 Bialystok Poland
Oncological Center of the Lublin Region ul dr K Jaczewskiego 720 090 Lublin Poland
SOTIO a s Jankovcova 1518 2 170 00 Prague 7 Czech Republic
University Hospital of Cologne Kerpener Str 34 50931 Cologne Germany
References provided by Crossref.org
Trial watch: Dendritic cell (DC)-based immunotherapy for cancer
ClinicalTrials.gov
NCT02107950
