Clinical trial · Interventional
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
NCT03905902CI-TRIAL-00055648VITALIAwithdrawnPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Company decision
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DCVAC/OvCa | Biological | — | UNRESOLVED |
| DCVAC/OvCa placebo | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 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
- interventionNames
- Biological: DCVAC/OvCa
- Biological: DCVAC/OvCa placebo
- type
- PLACEBO_COMPARATOR
- label
- Placebo with standard of care
- description
- 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
- interventionNames
- Biological: DCVAC/OvCa
- Biological: DCVAC/OvCa placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.