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

Primary Purpose

Ovarian Neoplasms, Ovarian Cancer (OvCa), Ovarian Epithelial Cancer

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

DCVAC/OvCa in parallel with chemotherapy

Standard of Care

About this trial

This is an interventional treatment trial for Ovarian Neoplasms focused on measuring Ovarian, Platinum Sensitive, Epithelial

Eligibility Criteria

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DCVAC/OvCa in parallel with chemotherapy

Standard of Care

Arm Description

Combination therapy with DCVAC/OvCa and Standard of Care

Standard of Care carboplatin and gemcitabine

Outcomes

Primary Outcome Measures

Determine median progression free survival

Secondary Outcome Measures

Overall survival (all causes)

Objective Response Rate

Biological Progression Free Interval

Immunological Response

Frequency of adverse events

Full Information

NCT ID

NCT02107950

First Posted

April 4, 2014

Last Updated

August 13, 2018

Sponsor

SOTIO a.s.

1. Study Identification

Unique Protocol Identification Number

NCT02107950

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

May 17, 2017 (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 (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).

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).

6. Conditions and Keywords

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

Ovarian Neoplasms, Ovarian Cancer (OvCa), Ovarian Epithelial Cancer

Keywords

Ovarian, Platinum Sensitive, Epithelial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DCVAC/OvCa in parallel with chemotherapy

Arm Type

Experimental

Arm Description

Combination therapy with DCVAC/OvCa and Standard of Care

Arm Title

Standard of Care

Arm Type

Active Comparator

Arm Description

Standard of Care carboplatin and gemcitabine

Intervention Type

Biological

Intervention Name(s)

DCVAC/OvCa in parallel with chemotherapy

Other Intervention Name(s)

DCVAC/OvCa, carboplatin and gemcitabine

Intervention Description

DCVAC/OvCa is the experimental therapy added on to Carboplatin and Gemcitabine

Intervention Type

Drug

Intervention Name(s)

Standard of Care

Other Intervention Name(s)

Carboplatin and Gemcitabine

Intervention Description

Carboplatin and Gemcitabine is Standard of Care First Line Chemotherapy

Primary Outcome Measure Information:

Title

Determine median progression free survival

Time Frame

72 Week

Secondary Outcome Measure Information:

Title

Overall survival (all causes)

Time Frame

56, 64, 72 weeks

Title

Objective Response Rate

Time Frame

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

Title

Biological Progression Free Interval

Time Frame

6, 12, 18, 24, 36, 42, 48, 56, 64, 72 weeks

Title

Immunological Response

Time Frame

24, 48, 72 weeks

Title

Frequency of adverse events

Time Frame

8, 16, 24, 32, 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 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

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

Czechia

City

Brno

ZIP/Postal Code

656 53

Country

Czechia

City

Ceske Budejovice

ZIP/Postal Code

370 01

Country

Czechia

City

Hradec Králové

ZIP/Postal Code

500 05

Country

Czechia

City

Nový Jičín

ZIP/Postal Code

741 01

Country

Czechia

City

Olomouc

ZIP/Postal Code

755 20

Country

Czechia

City

Ostrava

ZIP/Postal Code

708 52

Country

Czechia

City

Prague

ZIP/Postal Code

128 08

Country

Czechia

City

Praha 5

ZIP/Postal Code

150 06

Country

Czechia

City

Cologne

ZIP/Postal Code

50931

Country

Germany

City

Dresden

ZIP/Postal Code

01307

Country

Germany

City

Erlangen

ZIP/Postal Code

91 054

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

Yes

IPD Sharing Plan Description

will be posted to EMA website

IPD Sharing Time Frame

estimate end of 2018

Citations:

PubMed Identifier

34294416

Citation

Cibula D, Rob L, Mallmann P, Knapp P, Klat J, Chovanec J, Minar L, Melichar B, Hein A, Kieszko D, Pluta M, Spacek J, Bartos P, Wimberger P, Madry R, Markowska J, Streb J, Valha P, Hassan HIB, Pecen L, Galluzzi L, Fucikova J, Hrnciarova T, Hraska M, Bartunkova J, Spisek R. Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial. Gynecol Oncol. 2021 Sep;162(3):652-660. doi: 10.1016/j.ygyno.2021.07.003. Epub 2021 Jul 20.

Results Reference

derived

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

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