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Efficacy of DCVAC/OvCa Plus Standard of Care in Relapsed Platinum Resistant Epithelial Ovarian Carcinoma
A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial Evaluating Effect of Addition of DCVAC/OvCa to Standard Chemotherapy in Women With Relapsed Platinum (Pt)-Resistant Epithelial Ovarian Carcinoma
1 other identifier
interventional
22
3 countries
12
Brief Summary
The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy may result in prolongation of Overall Survival (OS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2014
12 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
January 1, 2014
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
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedNovember 30, 2016
January 1, 2016
2.6 years
April 4, 2014
November 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival (all cause mortality)
72 weeks
Secondary Outcomes (6)
Progression Free Survival
72 weeks
Objective Response Rate
0, 8, 16, ,24, 32, 40, 48, 56, 64, 72 weeks
Biological Progression Free Interval
0, 8, 16, 24, 32, 40, 48, 56, 64, 72 weeks
Immunological Response
0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 weeks
Frequency of Adverse Events
0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56, 64, 72 weeks
- +1 more secondary outcomes
Study Arms (2)
DCVAC/OvCa in parallel with chemo (SoC)
EXPERIMENTALCombination therapy with DCVAC/OvCa and Standard of Care (SoC)
Standard of Care (Chemotherapy)
ACTIVE COMPARATORStandard of Care as an Active Comparator (Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy)
Interventions
DCVAC/OvCa is the experimental therapy added on to Paclitaxel or topotecan or doxorubicin
Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy
Eligibility Criteria
You may qualify if:
- Females 18 years or older
- 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 have undergone initial surgery or interval debulking surgery but have not reached complete remission of more than 6 months after first line platinum based chemotherapy, for one of the following reasons
- Patients are platinum-refractory (no response)
- Complete remission was not reached (partial responders)
- Relapse within ≤6 months of remission (Platinum-resistant)
- Platinum-based chemotherapy failure should have been confirmed by computerized tomography (CT)/magnetic resonance imaging (MRI) scan (Platinum-resistant) or by finding described as 'did not reach complete clinical remission' (Platinum-refractory or Platinum-partial response) Patients must have at least one measureable target lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
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
- Clinically significant cardiovascular disease
- Active autoimmune disease requiring treatment
- History of severe forms of primary immune deficiencies
- Systemic immunosuppressive therapy for any reason
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SOTIO a.s.lead
Study Sites (12)
Unknown Facility
Brno, 625 00, Czechia
Unknown Facility
Nový Jičín, 741 01, Czechia
Unknown Facility
Olomouc, 775 20, Czechia
Unknown Facility
Ostrava, 708 52, Czechia
Unknown Facility
Prague, 150 06, Czechia
Unknown Facility
Cologne, 50931, Germany
Unknown Facility
Dresden, 01307, Germany
Unknown Facility
Erlangen, 91054, 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
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
January 1, 2014
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
November 30, 2016
Record last verified: 2016-01