Efficacy of DCVAC/OvCa Plus Standard of Care in Relapsed Platinum Resistant Epithelial Ovarian Carcinoma
NCT ID: NCT02107378
Last Updated: 2016-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
22 participants
INTERVENTIONAL
2014-01-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DCVAC/OvCa in parallel with chemo (SoC)
Combination therapy with DCVAC/OvCa and Standard of Care (SoC)
DCVAC/OvCa
DCVAC/OvCa is the experimental therapy added on to Paclitaxel or topotecan or doxorubicin
Standard of Care (Chemotherapy)
Standard of Care as an Active Comparator (Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy)
Standard of Care (Paclitaxel or topotecan or doxorubicin)
Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy
Interventions
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DCVAC/OvCa
DCVAC/OvCa is the experimental therapy added on to Paclitaxel or topotecan or doxorubicin
Standard of Care (Paclitaxel or topotecan or doxorubicin)
Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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SOTIO a.s.
INDUSTRY
Responsible Party
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Principal Investigators
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Ales Horacek
Role: STUDY_DIRECTOR
Accord Research
Locations
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Brno, , Czechia
Nový Jičín, , Czechia
Olomouc, , Czechia
Ostrava, , Czechia
Prague, , Czechia
Cologne, , Germany
Dresden, , Germany
Erlangen, , Germany
Bialystok, , Poland
Krakow, , Poland
Lublin, , Poland
Poznan, , Poland
Countries
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Other Identifiers
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SOV03
Identifier Type: -
Identifier Source: org_study_id