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

Sponsor

SOTIO a.s. (Industry)

Overall Status

Terminated

CT.gov ID

NCT02107378

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

1.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jan 1, 2014

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

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

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

Primary Outcome Measures

Overall survival (all cause mortality) [72 weeks]

Secondary Outcome Measures

Progression Free Survival [72 weeks]
Per modified RECIST
Objective Response Rate [0, 8, 16, ,24, 32, 40, 48, 56, 64, 72 weeks]
Per RECIST
Biological Progression Free Interval [0, 8, 16, 24, 32, 40, 48, 56, 64, 72 weeks]
Immunological Response [0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 weeks]
Frequency of Adverse Events [0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56, 64, 72 weeks]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	City	Country	Postal Code
1	Brno	Czech Republic	625 00
2	Nový Jičín	Czech Republic	741 01
3	Olomouc	Czech Republic	775 20
4	Ostrava	Czech Republic	708 52
5	Prague	Czech Republic	150 06
6	Cologne	Germany	50931
7	Dresden	Germany	01307
8	Erlangen	Germany	91054
9	Bialystok	Poland	15-276
10	Krakow	Poland	31-501
11	Lublin	Poland	20-081
12	Poznan	Poland	60-569