Phase II Study DCVAC/OvCa Plus Carboplatin Gemcitabine Relapsed Platinum (Pt)-Sensitive Epithelial Ovarian Carcinoma
NCT ID: NCT02107950
Last Updated: 2018-08-15
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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COMPLETED
PHASE2
71 participants
INTERVENTIONAL
2013-11-30
2017-05-17
Brief Summary
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Detailed Description
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Conditions
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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 chemotherapy
Combination therapy with DCVAC/OvCa and Standard of Care
DCVAC/OvCa in parallel with chemotherapy
DCVAC/OvCa is the experimental therapy added on to Carboplatin and Gemcitabine
Standard of Care
Standard of Care carboplatin and gemcitabine
Standard of Care
Carboplatin and Gemcitabine is Standard of Care First Line Chemotherapy
Interventions
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DCVAC/OvCa in parallel with chemotherapy
DCVAC/OvCa is the experimental therapy added on to Carboplatin and Gemcitabine
Standard of Care
Carboplatin and Gemcitabine is Standard of Care First Line Chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
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
Brno, , Czechia
České Budějovice, , Czechia
Hradec Králové, , Czechia
Nový Jičín, , Czechia
Olomouc, , Czechia
Ostrava, , Czechia
Prague, , Czechia
Prague, , Czechia
Cologne, , Germany
Dresden, , Germany
Erlangen, , Germany
Bialystok, , Poland
Krakow, , Poland
Lublin, , Poland
Poznan, , Poland
Countries
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References
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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.
Other Identifiers
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2013-001323-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SOV02
Identifier Type: -
Identifier Source: org_study_id
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