DCVAC/OvCa and Standard of Care (SoC) in Relapsed Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma
- Conditions
- Ovarian CancerFallopian Tube CancerPeritoneal Carcinoma
- Interventions
- Biological: DCVAC/OvCaBiological: DCVAC/OvCa placebo
- Registration Number
- NCT03905902
- Lead Sponsor
- SOTIO a.s.
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DCVAC/OvCa with standard of care DCVAC/OvCa placebo 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 DCVAC/OvCa with standard of care DCVAC/OvCa 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 Placebo with standard of care DCVAC/OvCa Induction period: DCVAC Placebo with carboplatin and gemcitabine, or carboplatin and paclitaxel, or carboplatin and doxorubicin, with or without bevacizumab Maintenance Period:DCVAC placebo with bevacizumab, best supportive care or a PARPi carboplatin and gemcitabine or carboplatin and paclitaxel with or without bevacizumab, best supportive care or a PARPi Placebo with standard of care DCVAC/OvCa placebo Induction period: DCVAC Placebo with carboplatin and gemcitabine, or carboplatin and paclitaxel, or carboplatin and doxorubicin, with or without bevacizumab Maintenance Period:DCVAC placebo with bevacizumab, best supportive care or a PARPi carboplatin and gemcitabine or carboplatin and paclitaxel with or without bevacizumab, best supportive care or a PARPi
- Primary Outcome Measures
Name Time Method Overall Survival(OS) Assessed from enrolment up to study completion, approximately 6.6 years Defined as the time from randomization until the date of death due to any cause.
- Secondary Outcome Measures
Name Time Method Objective Response Rate Assessed from start of treatment to up to 4 years Assessment of Objective Response Rate per RECIST1.1 until objective progression as defined by the Investigator.
Duration of Response Assessed from start of study treatment up to 4 years Assessment of Duration of Response until objective progression per RECIST 1.1.
Biological Progression-Free Survival Assessed from randomization up to study completion up to 6.6 years. Defined as the time from randomization to the earlier date of assessment of biological progression evaluated by increasing CA 125 levels or death due to any cause in the absence of progression.
Progression-Free Survival (PFS) Assessed from enrollment to up to 4 years Defined as the time from randomization to the earlier date of objective progression or death due to any cause in the absence of progression.
Time to Relapse Assessed from start of treatment up to 4 years Assessment of Time to Relapse, per objective progression according to RECIST 1.1.
Safety Assessments: NCI CTCAE version 5.0 Assessed from Screening through 30 days after the completion of Investigational Medicinal Product approximately 18 months. Defined as the incidence, severity and outcome of treatment emergent adverse events (TEAEs), and serious adverse events (SAEs) assessed by NCI CTCAE version 5.0.