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Phase II Study DCVAC/OvCa Added to First Line Carboplatin and Paclitaxel Newly Diagnosed Epithelial Ovarian Carcinoma

Primary Purpose

Ovarian Neoplasms, Ovarian Epithelial Cancer

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

DCVAC/OvCa with Standard of Care

DCVAC/OvCa sequentially chemotherapy

Standard of Care

About this trial

This is an interventional treatment trial for Ovarian Neoplasms focused on measuring serous, endometrioid, mucinous, epithelial ovarian cancer

Eligibility Criteria

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

Inclusion Criteria:

Female aged ≥18 years
Patients with newly diagnosed, histologically confirmed, International Federation of Gynecology and Obstetrics (FIGO) stage III epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous, endometrioid or mucinous) who have undergone initial surgery up to 3 weeks before randomization and are selected to receive first line Standard of Care chemotherapy (optional prolongation to 6 weeks after surgery)
Optimally debulked (zero residuum) or maximal residuum <1cm
Eastern Cooperative Oncology Group (ECOG) Performance status 0,1,2

Exclusion Criteria:

FIGO I,II,IV epithelial ovarian cancer
FIGO III clear cells epithelial ovarian cancer
Non-epithelial ovarian cancer (OvCa), borderline tumors (tumors of low malignant potential)
Post-surgery residual disease with lesion(s) >1cm
Prior or current systemic anti-cancer therapy for ovarian cancer [for example chemotherapy, monoclonal antibody therapy (bevacizumab), tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy]
Previous or concurrent 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
Patient co-morbidities:Human immunodeficiency virus (HIV) positive, human T-lymphotropic virus (HTLV) positive, Active hepatitis B (HBV), active hepatitis C (HCV), active syphilis
Evidence of active bacterial, viral or fungal infection requiring systemic treatment
Clinically significant cardiovascular disease including:

Symptomatic congestive heart failure Unstable angina pectoris Serious cardiac arrhythmia requiring medication Uncontrolled hypertension Myocardial infarction or ventricular arrhythmia or stroke within a 6 month period before inclusion, ejection fraction (EF) < 40 percent or serious cardiac conduction system disorders, if a pacemaker is not present

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

DCVAC/OvCa with Standard of Care

DCVAC/OvCa sequentially chemotherapy

Standart of Care

Arm Description

DCVAC/OvCa in parallel with chemotherapy (Standard of Care)

DCVAC/OvCa sequentially after chemotherapy

Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy

Outcomes

Primary Outcome Measures

Overall progression free survival (PFS)

Secondary Outcome Measures

Proportion of patients in remission after first line chemotherapy at 6 months

Proportion of patients in remission after first line chemotherapy at 12 months

Biological progression free interval

Immunological Response

Proportion of patients requiring 2nd line chemotherapy

Frequency of Adverse Events

Time to 50 percent survival

Full Information

NCT ID

NCT02107937

First Posted

April 4, 2014

Last Updated

May 3, 2022

Sponsor

SOTIO a.s.

1. Study Identification

Unique Protocol Identification Number

NCT02107937

Brief Title

Phase II Study DCVAC/OvCa Added to First Line Carboplatin and Paclitaxel Newly Diagnosed Epithelial Ovarian Carcinoma

Official Title

A Randomized, Open-label, Three-arm, Multi-center Phase II Trial of Addition of DCVAC/OvCa to First Line Standard Chemotherapy in Women With Newly Diagnosed Epithelial Ovarian Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

November 2013 (Actual)

Primary Completion Date

November 2020 (Actual)

Study Completion Date

November 2021 (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 plus paclitaxel as first 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 plus paclitaxel as first 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 Epithelial Cancer

Keywords

serous, endometrioid, mucinous, epithelial ovarian cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

136 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DCVAC/OvCa with Standard of Care

Arm Type

Experimental

Arm Description

DCVAC/OvCa in parallel with chemotherapy (Standard of Care)

Arm Title

DCVAC/OvCa sequentially chemotherapy

Arm Type

Experimental

Arm Description

DCVAC/OvCa sequentially after chemotherapy

Arm Title

Standart of Care

Arm Type

Active Comparator

Arm Description

Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy

Intervention Type

Biological

Intervention Name(s)

DCVAC/OvCa with Standard of Care

Other Intervention Name(s)

Carboplatin, Paclitaxel

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

DCVAC/OvCa sequentially chemotherapy

Other Intervention Name(s)

Carboplatin, Paclitaxel

Intervention Description

DCVAC/OvCa added sequentially after Carboplatin and Paclitaxel

Intervention Type

Drug

Intervention Name(s)

Standard of Care

Other Intervention Name(s)

Carboplatin, Paclitaxel

Intervention Description

Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy

Primary Outcome Measure Information:

Title

Overall progression free survival (PFS)

Time Frame

104 weeks

Secondary Outcome Measure Information:

Title

Proportion of patients in remission after first line chemotherapy at 6 months

Time Frame

0,10, 18, 30, 42 weeks

Title

Proportion of patients in remission after first line chemotherapy at 12 months

Time Frame

0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks

Title

Biological progression free interval

Time Frame

0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks

Title

Immunological Response

Time Frame

0, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60 weeks

Title

Proportion of patients requiring 2nd line chemotherapy

Time Frame

0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks

Title

Frequency of Adverse Events

Time Frame

0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks

Title

Time to 50 percent survival

Time Frame

0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female aged ≥18 years Patients with newly diagnosed, histologically confirmed, International Federation of Gynecology and Obstetrics (FIGO) stage III epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous, endometrioid or mucinous) who have undergone initial surgery up to 3 weeks before randomization and are selected to receive first line Standard of Care chemotherapy (optional prolongation to 6 weeks after surgery) Optimally debulked (zero residuum) or maximal residuum <1cm Eastern Cooperative Oncology Group (ECOG) Performance status 0,1,2 Exclusion Criteria: FIGO I,II,IV epithelial ovarian cancer FIGO III clear cells epithelial ovarian cancer Non-epithelial ovarian cancer (OvCa), borderline tumors (tumors of low malignant potential) Post-surgery residual disease with lesion(s) >1cm Prior or current systemic anti-cancer therapy for ovarian cancer [for example chemotherapy, monoclonal antibody therapy (bevacizumab), tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy] Previous or concurrent 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 Patient co-morbidities:Human immunodeficiency virus (HIV) positive, human T-lymphotropic virus (HTLV) positive, Active hepatitis B (HBV), active hepatitis C (HCV), active syphilis Evidence of active bacterial, viral or fungal infection requiring systemic treatment Clinically significant cardiovascular disease including: Symptomatic congestive heart failure Unstable angina pectoris Serious cardiac arrhythmia requiring medication Uncontrolled hypertension Myocardial infarction or ventricular arrhythmia or stroke within a 6 month period before inclusion, ejection fraction (EF) < 40 percent or serious cardiac conduction system disorders, if a pacemaker is not present

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harald Fricke, MD, PhD

Organizational Affiliation

SOTIO a.s.

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

Hradec Králové

ZIP/Postal Code

500 05

Country

Czechia

City

Nový Jičín

ZIP/Postal Code

741 01

Country

Czechia

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

City

Ostrava

ZIP/Postal Code

708 52

Country

Czechia

City

Plzeň

ZIP/Postal Code

304 60

Country

Czechia

City

Praha 5

ZIP/Postal Code

150 06

Country

Czechia

City

Praha

ZIP/Postal Code

100 34

Country

Czechia

City

Praha

ZIP/Postal Code

128 08

Country

Czechia

City

České Budějovice

ZIP/Postal Code

370 01

Country

Czechia

City

Bialystok

ZIP/Postal Code

15-276

Country

Poland

City

Lublin

ZIP/Postal Code

20-090

Country

Poland

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

EMA website

Citations:

PubMed Identifier

35898703

Citation

Hensler M, Rakova J, Kasikova L, Lanickova T, Pasulka J, Holicek P, Hraska M, Hrnciarova T, Kadlecova P, Schoenenberger A, Sochorova K, Rozkova D, Sojka L, Drozenova J, Laco J, Horvath R, Podrazil M, Hongyan G, Brtnicky T, Halaska MJ, Rob L, Ryska A, Coosemans A, Vergote I, Garg AD, Cibula D, Bartunkova J, Spisek R, Fucikova J. Peripheral gene signatures reveal distinct cancer patient immunotypes with therapeutic implications for autologous DC-based vaccines. Oncoimmunology. 2022 Jul 22;11(1):2101596. doi: 10.1080/2162402X.2022.2101596. eCollection 2022.

Results Reference

derived

PubMed Identifier

35536547

Citation

Fucikova J, Hensler M, Kasikova L, Lanickova T, Pasulka J, Rakova J, Drozenova J, Fredriksen T, Hraska M, Hrnciarova T, Sochorova K, Rozkova D, Sojka L, Dundr P, Laco J, Brtnicky T, Praznovec I, Halaska MJ, Rob L, Ryska A, Coosemans A, Vergote I, Cibula D, Bartunkova J, Galon J, Galluzzi L, Spisek R. An Autologous Dendritic Cell Vaccine Promotes Anticancer Immunity in Patients with Ovarian Cancer with Low Mutational Burden and Cold Tumors. Clin Cancer Res. 2022 Jul 15;28(14):3053-3065. doi: 10.1158/1078-0432.CCR-21-4413.

Results Reference

derived

PubMed Identifier

34992091

Citation

Rob L, Cibula D, Knapp P, Mallmann P, Klat J, Minar L, Bartos P, Chovanec J, Valha P, Pluta M, Novotny Z, Spacek J, Melichar B, Kieszko D, Fucikova J, Hrnciarova T, Korolkiewicz RP, Hraska M, Bartunkova J, Spisek R. Safety and efficacy of dendritic cell-based immunotherapy DCVAC/OvCa added to first-line chemotherapy (carboplatin plus paclitaxel) for epithelial ovarian cancer: a phase 2, open-label, multicenter, randomized trial. J Immunother Cancer. 2022 Jan;10(1):e003190. doi: 10.1136/jitc-2021-003190.

Results Reference

derived

Learn more about this trial

Phase II Study DCVAC/OvCa Added to First Line Carboplatin and Paclitaxel Newly Diagnosed Epithelial Ovarian Carcinoma

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