Brief Title
DCVAC/OvCa and Standard of Care (SoC) in Relapsed Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma
Official Title
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
Brief Summary
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.
Detailed Description
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
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Overall Survival(OS)
Secondary Outcome
Progression-Free Survival (PFS)
Condition
Ovarian Cancer
Intervention
DCVAC/OvCa
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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
0
Start Date
August 2021
Completion Date
August 16, 2021
Primary Completion Date
August 2021
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Harald Fricke, MD PhD, ,
Administrative Informations
NCT ID
NCT03905902
Organization ID
SOV09
Secondary IDs
VITALIA/ ENGOT-ov53
Responsible Party
Sponsor
Study Sponsor
SOTIO a.s.
Collaborators
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Study Sponsor
Harald Fricke, MD PhD, Study Director, SOTIO a.s.
Verification Date
December 2021