Efficacy of DCVAC/OvCa Plus Standard of Care in Relapsed Platinum Resistant Epithelial Ovarian Carcinoma

Epithelial Ovarian Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02107378
• Other study ID #: SOV03
• Status: Terminated
• Phase: Phase 2
• First received: April 4, 2014
• Last updated: November 29, 2016
• Start date: January 2014
• Est. completion date: August 2016

Study information

• Verified date: January 2016
• Source: Sotio a.s.
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines AgencyCzech Republic: State Institute for Drug ControlPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsGermany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy may result in prolongation of Overall Survival (OS).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Epithelial Ovarian Carcinoma
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms

Intervention

Biological:
• DCVAC/OvCa
DCVAC/OvCa is the experimental therapy added on to Paclitaxel or topotecan or doxorubicin

Drug:
• Standard of Care (Paclitaxel or topotecan or doxorubicin)
Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sotio a.s.

Countries where clinical trial is conducted

Czech Republic,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (all cause mortality)		72 weeks	Yes
Secondary	Progression Free Survival	Per modified RECIST	72 weeks	No
Secondary	Objective Response Rate	Per RECIST	0, 8, 16, ,24, 32, 40, 48, 56, 64, 72 weeks	No
Secondary	Biological Progression Free Interval		0, 8, 16, 24, 32, 40, 48, 56, 64, 72 weeks	No
Secondary	Immunological Response		0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 weeks	No
Secondary	Frequency of Adverse Events		0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56, 64, 72 weeks	Yes
Secondary	Evaluation of Quality of Life via Functional Assessment of Cancer Therapy-Ovarian		0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56, 64, 72 weeks	No