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

Primary Purpose

Epithelial Ovarian Carcinoma

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

DCVAC/OvCa

Standard of Care (Paclitaxel or topotecan or doxorubicin)

About this trial

This is an interventional treatment trial for Epithelial Ovarian Carcinoma focused on measuring Immunotherapy, Serous, Relapsed, Platinum resistant (pt), Ovarian Cancer (OvCa), Biological, Vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DCVAC/OvCa in parallel with chemo (SoC)

Standard of Care (Chemotherapy)

Arm Description

Combination therapy with DCVAC/OvCa and Standard of Care (SoC)

Standard of Care as an Active Comparator (Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy)

Outcomes

Primary Outcome Measures

Overall survival (all cause mortality)

Secondary Outcome Measures

Progression Free Survival

Per modified RECIST

Objective Response Rate

Per RECIST

Biological Progression Free Interval

Immunological Response

Frequency of Adverse Events

Evaluation of Quality of Life via Functional Assessment of Cancer Therapy-Ovarian

Full Information

NCT ID

NCT02107378

First Posted

April 4, 2014

Last Updated

November 29, 2016

Sponsor

SOTIO a.s.

1. Study Identification

Unique Protocol Identification Number

NCT02107378

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Terminated

Why Stopped

sponsor decision

Study Start Date

January 2014 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SOTIO a.s.

4. Oversight

Data Monitoring Committee

Yes

5. 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).

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epithelial Ovarian Carcinoma

Keywords

Immunotherapy, Serous, Relapsed, Platinum resistant (pt), Ovarian Cancer (OvCa), Biological, Vaccine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DCVAC/OvCa in parallel with chemo (SoC)

Arm Type

Experimental

Arm Description

Combination therapy with DCVAC/OvCa and Standard of Care (SoC)

Arm Title

Standard of Care (Chemotherapy)

Arm Type

Active Comparator

Arm Description

Standard of Care as an Active Comparator (Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy)

Intervention Type

Biological

Intervention Name(s)

DCVAC/OvCa

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Standard of Care (Paclitaxel or topotecan or doxorubicin)

Other Intervention Name(s)

Paclitaxel, topotecan, doxorubicin

Intervention Description

Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy

Primary Outcome Measure Information:

Title

Overall survival (all cause mortality)

Time Frame

72 weeks

Secondary Outcome Measure Information:

Title

Progression Free Survival

Description

Per modified RECIST

Time Frame

72 weeks

Title

Objective Response Rate

Description

Per RECIST

Time Frame

0, 8, 16, ,24, 32, 40, 48, 56, 64, 72 weeks

Title

Biological Progression Free Interval

Time Frame

0, 8, 16, 24, 32, 40, 48, 56, 64, 72 weeks

Title

Immunological Response

Time Frame

0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 weeks

Title

Frequency of Adverse Events

Time Frame

0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56, 64, 72 weeks

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ales Horacek

Organizational Affiliation

Accord Research

Official's Role

Study Director

Facility Information:

City

Brno

ZIP/Postal Code

625 00

Country

Czech Republic

City

Nový Jičín

ZIP/Postal Code

741 01

Country

Czech Republic

City

Olomouc

ZIP/Postal Code

775 20

Country

Czech Republic

City

Ostrava

ZIP/Postal Code

708 52

Country

Czech Republic

City

Prague

ZIP/Postal Code

150 06

Country

Czech Republic

City

Cologne

ZIP/Postal Code

50931

Country

Germany

City

Dresden

ZIP/Postal Code

01307

Country

Germany

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

City

Bialystok

ZIP/Postal Code

15-276

Country

Poland

City

Krakow

ZIP/Postal Code

31-501

Country

Poland

City

Lublin

ZIP/Postal Code

20-081

Country

Poland

City

Poznan

ZIP/Postal Code

60-569

Country

Poland

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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