Study to Allow for Second Treatment Cycle of DCVAC in Patients With Localized Prostate Cancer
NCT ID: NCT02137746
Last Updated: 2017-05-24
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
24 participants
INTERVENTIONAL
2013-12-31
2017-03-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DCVAC/PCa Arm
Dendritic Cells DCVAC/PCa Experimental therapy
Dendritic Cells DCVAC/PCa
DCVAC/PCa Experimental therapy
Interventions
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Dendritic Cells DCVAC/PCa
DCVAC/PCa Experimental therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed prostate adenocarcinoma Stage pathological tumor-2 (pT2)
* Post radical Primary Prostatectomy
* Completion of DCVAC/PCa arm in Study SP003, without objective progression of the disease
Exclusion Criteria
* Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater
* Other uncontrolled intercurrent illness
* Treatment with immunotherapy against PCa
* Clinically significant cardiovascular disease
* Active autoimmune disease requiring treatment
18 Years
MALE
No
Sponsors
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SOTIO a.s.
INDUSTRY
Responsible Party
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Principal Investigators
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Tomas Scheiner, PhD
Role: STUDY_DIRECTOR
Sotio Biotech Inc.
Locations
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Hradec Králové, , Czechia
Jablonec nad Nisou, , Czechia
Nový Jičín, , Czechia
Olomouc, , Czechia
Prague, , Czechia
Uherské Hradiště, , Czechia
Ústí nad Labem, , Czechia
Countries
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Other Identifiers
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2013-003809-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SP010
Identifier Type: -
Identifier Source: org_study_id
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