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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sotio a.s.
ClinicalTrials.gov Identifier:
NCT02107950
First received: April 4, 2014
Last updated: January 12, 2016
Last verified: January 2016
  Purpose
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 Intervention Phase
Ovarian Neoplasms
Ovarian Cancer (OvCa)
Ovarian Epithelial Cancer
Biological: DCVAC/OvCa in parallel with chemotherapy
Drug: Standard of Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sotio a.s.:

Primary Outcome Measures:
  • Determine median progression free survival [ Time Frame: 72 Week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (all causes) [ Time Frame: 56, 64, 72 weeks ] [ Designated as safety issue: Yes ]
  • Objective Response Rate [ Time Frame: 8, 16, 24, 32, 40, 48, 56. 64. 72 weeks ] [ Designated as safety issue: No ]
  • Biological Progression Free Interval [ Time Frame: 6, 12, 18, 24, 36, 42, 48, 56, 64, 72 weeks ] [ Designated as safety issue: No ]
  • Immunological Response [ Time Frame: 24, 48, 72 weeks ] [ Designated as safety issue: No ]
  • Frequency of adverse events [ Time Frame: 8, 16, 24, 32, 40, 48, 56. 64. 72 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: November 2013
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02107950

Locations
Czech Republic
Brno, Czech Republic, 625 00
Brno, Czech Republic, 656 53
Ceske Budejovice, Czech Republic, 370 01
Hradec Králové, Czech Republic, 500 05
Nový Jičín, Czech Republic, 741 01
Olomouc, Czech Republic, 755 20
Ostrava, Czech Republic, 708 52
Prague, Czech Republic, 128 08
Praha 5, Czech Republic
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
Study Director: Ales Horacek Accord Research
  More Information

Responsible Party: Sotio a.s.
ClinicalTrials.gov Identifier: NCT02107950     History of Changes
Other Study ID Numbers: SOV02  2013-001323-38 
Study First Received: April 4, 2014
Last Updated: January 12, 2016
Health Authority: Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Germany: Paul-Ehrlich-Institut

Keywords provided by Sotio a.s.:
Ovarian
Platinum Sensitive
Epithelial

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Hypersensitivity
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Immune System Diseases
Gemcitabine
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2016