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Phase II Study DCVAC/OvCa Plus Carboplatin Gemcitabine Relapsed Platinum (Pt)-Sensitive Epithelial Ovarian Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02107950
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
SOTIO Biotech ( SOTIO a.s. )

Study Description
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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).

Condition or disease Intervention/treatment Phase
Ovarian Neoplasms Ovarian Cancer (OvCa) Ovarian Epithelial Cancer Biological: DCVAC/OvCa in parallel with chemotherapy Drug: Standard of Care Phase 2

Detailed Description:
The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : May 17, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: DCVAC/OvCa in parallel with chemotherapy
Combination therapy with DCVAC/OvCa and Standard of Care
 Biological: DCVAC/OvCa in parallel with chemotherapy
DCVAC/OvCa is the experimental therapy added on to Carboplatin and Gemcitabine
Other Names:
  • DCVAC/OvCa
  • carboplatin and gemcitabine
Active Comparator: Standard of Care
Standard of Care carboplatin and gemcitabine
 Drug: Standard of Care
Carboplatin and Gemcitabine is Standard of Care First Line Chemotherapy
Other Name: Carboplatin and Gemcitabine


Outcome Measures
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Primary Outcome Measures :
  1. Determine median progression free survival [ Time Frame: 72 Week ]

Secondary Outcome Measures :
  1. Overall survival (all causes) [ Time Frame: 56, 64, 72 weeks ]
  2. Objective Response Rate [ Time Frame: 8, 16, 24, 32, 40, 48, 56. 64. 72 weeks ]
  3. Biological Progression Free Interval [ Time Frame: 6, 12, 18, 24, 36, 42, 48, 56, 64, 72 weeks ]
  4. Immunological Response [ Time Frame: 24, 48, 72 weeks ]
  5. Frequency of adverse events [ Time Frame: 8, 16, 24, 32, 40, 48, 56. 64. 72 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107950


Locations
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Czechia
Brno, Czechia, 625 00
Brno, Czechia, 656 53
Ceske Budejovice, Czechia, 370 01
Hradec Králové, Czechia, 500 05
Nový Jičín, Czechia, 741 01
Olomouc, Czechia, 755 20
Ostrava, Czechia, 708 52
Prague, Czechia, 128 08
Praha 5, Czechia, 150 06
Germany
Cologne, Germany, 50931
Dresden, Germany, 01307
Erlangen, Germany, 91 054
Poland
Bialystok, Poland, 15-276
Krakow, Poland, 31-501
Lublin, Poland, 20-081
Poznan, Poland, 60-569
Sponsors and Collaborators
SOTIO a.s.
Investigators
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Study Director: Ales Horacek Accord Research
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: SOTIO a.s.
ClinicalTrials.gov Identifier: NCT02107950    
Other Study ID Numbers: SOV02
2013-001323-38 ( EudraCT Number )
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: will be posted to EMA website
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: estimate end of 2018
Keywords provided by SOTIO Biotech ( SOTIO a.s. ):
Ovarian
Platinum Sensitive
Epithelial
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Hypersensitivity
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Immune System Diseases
Carboplatin
Gemcitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action