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| ID | Type | Description | Link |
|---|---|---|---|
| VITALIA/ ENGOT-ov53 | Other Identifier | ENGOT |
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Company decision
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| Name | Class |
|---|---|
| European Network of Gynaecological Oncological Trial Groups (ENGOT) | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCVAC/OvCa with standard of care | Experimental | 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 | Placebo Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCVAC/OvCa | Biological | activated autologous dendritic cells |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | Defined as the time from randomization until the date of death due to any cause. | Assessed from enrolment up to study completion, approximately 6.6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Defined as the time from randomization to the earlier date of objective progression or death due to any cause in the absence of progression. | Assessed from enrollment to up to 4 years |
| Objective Response Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harald Fricke, MD PhD | SOTIO a.s. | Study Director |
| David Cibula, Prof. MD PhD | The Central and Eastern European Gynecologic Oncology Group | Principal Investigator |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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parallel-group, placebo-controlled
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double-blind
| DCVAC/OvCa placebo | Biological | placebo for activated autologous cells |
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Assessment of Objective Response Rate per RECIST1.1 until objective progression as defined by the Investigator.
| Assessed from start of treatment to up to 4 years |
| Time to Relapse | Assessment of Time to Relapse, per objective progression according to RECIST 1.1. | Assessed from start of treatment up to 4 years |
| Duration of Response | Assessment of Duration of Response until objective progression per RECIST 1.1. | Assessed from start of study treatment up to 4 years |
| Biological Progression-Free Survival | 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. | Assessed from randomization up to study completion up to 6.6 years. |
| Safety Assessments: NCI CTCAE version 5.0 | 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. | Assessed from Screening through 30 days after the completion of Investigational Medicinal Product approximately 18 months. |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |