DCVAC/OvCa and Standard of Care (SoC) in Relapsed Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma
A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of DCVAC/OvCa Added to Standard of Care in Patients With Relapsed Platinum-sensitive Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma
Multi-center, phase III trial of DCVAC/OvCa added to standard of care treatments for relapsed ovarian cancer. Patients will receive study treatment until all doses are administered, or other criteria are met.
All patients who meet entry criteria will be randomized, and will undergo a leukapheresis procedure. During the Induction period, all patients will receive DCVAC/OvCa or placebo (study treatment) with concurrent standard-of-care platinum-based chemotherapy, with or without use of bevacizumab. In the Maintenance period, patients will continue treatment with study treatment in combination with bevacizumab, a poly (ADP-ribose) polymerase inhibitor (PARPi) or best supportive care only. Study treatment will continue irrespective of disease progression
Progression-Free Survival (PFS)
Study Arms / Comparison Groups
DCVAC/OvCa with standard of care
Description: Induction period: DCVAC/OvCa with carboplatin and gemcitabine, or carboplatin and paclitaxel, or carboplatin and pegylated liposomal doxorubicin, with or without bevacizumab Maintenance period: DCVAC/OvCa with bevacizumab, best supportive care or a PARPi
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
August 16, 2021
Primary Completion Date
Inclusion Criteria: - Histologically confirmed high-grade serous or endometrioid carcinoma of the ovary, peritoneum or fallopian tube. - Without disease progression during preceding platinum-based chemotherapy - Platinum-sensitive patients defined as Platinum-Free Interval of more than 6 months between the end of the last cycle of platinum-based chemotherapy and radiologic evidence of progression. - First relapse identified by the criteria above up to 28 days prior to study randomization - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Known BRCA (breast cancer susceptibility gene) mutation status before randomization - Patient is intended to be treated with bevacizumab, best supportive care (BSC) only or PARPi Exclusion Criteria: - Tumor-specific: any other histology sub-type that is not high grade serous or endometrioid, however a combination of these is allowed - Disease Treatment history: started or ongoing systemic treatment for current relapse of Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer before signing informed consent form (ICF), concomitant use of anti-neoplastic anti- hormonal therapy - Intention to treat with intra-peritoneal chemotherapy
18 Years - N/A
Accepts Healthy Volunteers
Harald Fricke, MD PhD, ,
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Harald Fricke, MD PhD, Study Director, SOTIO a.s.