Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Carcinoma
Conditions
Keywords
active cellular immunotherapy, dendritic cells, platinum-sensitive, relapsed ovarian cancer, biologic
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
Interventions
BIOLOGICALDCVAC/OvCa
activated autologous dendritic cells
BIOLOGICALDCVAC/OvCa placebo
placebo for activated autologous cells
Sponsors
European Network of Gynaecological Oncological Trial Groups (ENGOT)
SOTIO a.s.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double-blind
Intervention model description
parallel-group, placebo-controlled
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Outcome results
None listed