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
2 other identifiers
interventional
71
3 countries
16
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2013
Typical duration for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 4, 2014
CompletedFirst Posted
Study publicly available on registry
April 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2017
CompletedAugust 15, 2018
January 1, 2016
3 years
April 4, 2014
August 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine median progression free survival
72 Week
Secondary Outcomes (5)
Overall survival (all causes)
56, 64, 72 weeks
Objective Response Rate
8, 16, 24, 32, 40, 48, 56. 64. 72 weeks
Biological Progression Free Interval
6, 12, 18, 24, 36, 42, 48, 56, 64, 72 weeks
Immunological Response
24, 48, 72 weeks
Frequency of adverse events
8, 16, 24, 32, 40, 48, 56. 64. 72 weeks
Study Arms (2)
DCVAC/OvCa in parallel with chemotherapy
EXPERIMENTALCombination therapy with DCVAC/OvCa and Standard of Care
Standard of Care
ACTIVE COMPARATORStandard of Care carboplatin and gemcitabine
Interventions
DCVAC/OvCa is the experimental therapy added on to Carboplatin and Gemcitabine
Carboplatin and Gemcitabine is Standard of Care First Line Chemotherapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SOTIO a.s.lead
Study Sites (16)
Unknown Facility
Brno, 625 00, Czechia
Unknown Facility
Brno, 656 53, Czechia
Unknown Facility
České Budějovice, 370 01, Czechia
Unknown Facility
Hradec Králové, 500 05, Czechia
Unknown Facility
Nový Jičín, 741 01, Czechia
Unknown Facility
Olomouc, 755 20, Czechia
Unknown Facility
Ostrava, 708 52, Czechia
Unknown Facility
Prague, 128 08, Czechia
Unknown Facility
Prague, 150 06, Czechia
Unknown Facility
Cologne, 50931, Germany
Unknown Facility
Dresden, 01307, Germany
Unknown Facility
Erlangen, 91 054, Germany
Unknown Facility
Bialystok, 15-276, Poland
Unknown Facility
Krakow, 31-501, Poland
Unknown Facility
Lublin, 20-081, Poland
Unknown Facility
Poznan, 60-569, Poland
Related Publications (1)
Cibula 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: 34294416DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ales Horacek
Accord Research
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2014
First Posted
April 8, 2014
Study Start
November 1, 2013
Primary Completion
November 1, 2016
Study Completion
May 17, 2017
Last Updated
August 15, 2018
Record last verified: 2016-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- estimate end of 2018
will be posted to EMA website