Clinical trial · Interventional
Phase II Study DCVAC/OvCa Plus Carboplatin Gemcitabine Relapsed Platinum (Pt)-Sensitive Epithelial Ovarian Carcinoma
A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial DCVAC/OvCa Added to Standard Chemotherapy in Women With Relapsed Platinum Sensitive Epithelial Ovarian Carcinoma
NCT02107950CI-TRIAL-00034373completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).
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 |
|---|---|---|---|
| Ovarian Cancer (OvCa) | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.85 |
| Ovarian Epithelial Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DCVAC/OvCa in parallel with chemotherapy | Biological | — | UNRESOLVED |
| Standard of Care | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DCVAC/OvCa in parallel with chemotherapy
- description
- Combination therapy with DCVAC/OvCa and Standard of Care
- interventionNames
- Biological: DCVAC/OvCa in parallel with chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care
- description
- Standard of Care carboplatin and gemcitabine
- interventionNames
- Drug: Standard of Care
Primary outcomes (1)
- measure
- Determine median progression free survival
- timeFrame
- 72 Week
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Females 18 years old and older * Patients with histologically confirmed, International Federation of Gynecology and Obstetrics (FIGO) stage III or IV epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous, endometrioid or mucinous), who had complete remission after first line platinum (Pt)-based chemotherapy and are selected to receive second line Standard of Care chemotherapy * Radiologically confirmed relapse after \>6 months of remission (Platinum-sensitive patients), found up to 4 weeks prior study entry. * The patient must have at least one measureable target lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria to be eligible for enrolment in the study Exclusion Criteria: * FIGO I,II epithelial ovarian cancer * FIGO III, IV clear cells epithelial ovarian cancer * Non-epithelial ovarian cancer * Borderline tumors (tumors of low malignant potential) * Prior or current systemic anti-cancer therapy for ovarian cancer \[for example chemotherapy, monoclonal antibody therapy , tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy\] except first line Platinum-based chemotherapy (with or without bevacizumab) * Previous radiotherapy to the abdomen and pelvis * Malignancy other than epithelial ovarian cancer, except those that have been in clinical remission (CR) for a minimum of 3 years, and except carcinoma in-situ of the cervix or non-melanoma skin carcinomas
References
Publications (1)
- DERIVEDCibula D, Rob L, Mallmann P, Knapp P, Klat J, Chovanec J, Minar L, Melichar B, Hein A, Kieszko D, Pluta M, Spacek J, Bartos P, Wimberger P, Madry R, Markowska J, Streb J, Valha P, Hassan HIB, Pecen L, Galluzzi L, Fucikova J, Hrnciarova T, Hraska M, Bartunkova J, Spisek R. Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial. Gynecol Oncol. 2021 Sep;162(3):652-660. doi: 10.1016/j.ygyno.2021.07.003. Epub 2021 Jul 20. PMID 34294416