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Efficacy of DCVAC/OvCa Plus Standard of Care in Relapsed Platinum Resistant 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: NCT02107378
Recruitment Status : Terminated (sponsor decision)
First Posted : April 8, 2014
Last Update Posted : November 30, 2016
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 may result in prolongation of Overall Survival (OS).

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Carcinoma Biological: DCVAC/OvCa Drug: Standard of Care (Paclitaxel or topotecan or doxorubicin) Phase 2

Detailed Description:
The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy may result in prolongation of Overall Survival (OS).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 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 Evaluating Effect of Addition of DCVAC/OvCa to Standard Chemotherapy in Women With Relapsed Platinum (Pt)-Resistant Epithelial Ovarian Carcinoma
Study Start Date : January 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: DCVAC/OvCa in parallel with chemo (SoC)
Combination therapy with DCVAC/OvCa and Standard of Care (SoC)
 Biological: DCVAC/OvCa
DCVAC/OvCa is the experimental therapy added on to Paclitaxel or topotecan or doxorubicin
Active Comparator: Standard of Care (Chemotherapy)
Standard of Care as an Active Comparator (Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy)
 Drug: Standard of Care (Paclitaxel or topotecan or doxorubicin)
Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy
Other Names:
  • Paclitaxel
  • topotecan
  • doxorubicin


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival (all cause mortality) [ Time Frame: 72 weeks ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 72 weeks ]
    Per modified RECIST

  2. Objective Response Rate [ Time Frame: 0, 8, 16, ,24, 32, 40, 48, 56, 64, 72 weeks ]
    Per RECIST

  3. Biological Progression Free Interval [ Time Frame: 0, 8, 16, 24, 32, 40, 48, 56, 64, 72 weeks ]
  4. Immunological Response [ Time Frame: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 weeks ]
  5. Frequency of Adverse Events [ Time Frame: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56, 64, 72 weeks ]
  6. Evaluation of Quality of Life via Functional Assessment of Cancer Therapy-Ovarian [ Time Frame: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 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 or older
  • 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 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
  • Clinically significant cardiovascular disease
  • Active autoimmune disease requiring treatment
  • History of severe forms of primary immune deficiencies
  • Systemic immunosuppressive therapy for any reason
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): NCT02107378


Locations
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Czech Republic
Brno, Czech Republic, 625 00
Nový Jičín, Czech Republic, 741 01
Olomouc, Czech Republic, 775 20
Ostrava, Czech Republic, 708 52
Prague, Czech Republic, 150 06
Germany
Cologne, Germany, 50931
Dresden, Germany, 01307
Erlangen, Germany, 91054
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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Responsible Party: SOTIO a.s.
ClinicalTrials.gov Identifier: NCT02107378    
Other Study ID Numbers: SOV03
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by SOTIO Biotech ( SOTIO a.s. ):
Immunotherapy
Serous
Relapsed
Platinum resistant (pt)
 Ovarian Cancer (OvCa)
Biological
Vaccine
Additional relevant MeSH terms:
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Carcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
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
Paclitaxel
Albumin-Bound Paclitaxel
Doxorubicin
Liposomal doxorubicin
Topotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action