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

NCT02107937 | Completed Phase 2 DMC

• 2 other identifiers: SOV012013-001322-26
• Study Type: interventional
• Target: 136
• Locations: 2 countries
• Sites: 13

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).

Conditions

Ovarian Neoplasms; Ovarian Epithelial Cancer

Keywords

serous; endometrioid; mucinous; epithelial ovarian cancer

Outcome Measures

Primary Outcomes (1)

• Overall progression free survival (PFS)

  104 weeks

Secondary Outcomes (7)

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

  0,10, 18, 30, 42 weeks

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

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

• Biological progression free interval

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

• Immunological Response

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

• Proportion of patients requiring 2nd line chemotherapy

  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

Study Arms (3)

DCVAC/OvCa with Standard of Care

EXPERIMENTAL

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

Biological: DCVAC/OvCa with Standard of Care

DCVAC/OvCa sequentially chemotherapy

EXPERIMENTAL

DCVAC/OvCa sequentially after chemotherapy

Biological: DCVAC/OvCa sequentially chemotherapy

Standart of Care

ACTIVE COMPARATOR

Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy

Drug: Standard of Care

Interventions

DCVAC/OvCa with Standard of Care BIOLOGICAL

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

Also known as: Carboplatin, Paclitaxel

DCVAC/OvCa with Standard of Care

DCVAC/OvCa sequentially chemotherapy BIOLOGICAL

DCVAC/OvCa added sequentially after Carboplatin and Paclitaxel

Also known as: Carboplatin, Paclitaxel

DCVAC/OvCa sequentially chemotherapy

Standard of Care DRUG

Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy

Also known as: Carboplatin, Paclitaxel

Standart of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• SOTIO a.s.: lead

Study Sites (13)

Unknown Facility

Brno, 625 00, Czechia

Location

Unknown Facility

Brno, 656 53, Czechia

Location

Unknown Facility

České Budějovice, 370 01, Czechia

Location

Unknown Facility

Hradec Králové, 500 05, Czechia

Location

Unknown Facility

Nový Jičín, 741 01, Czechia

Location

Unknown Facility

Olomouc, 775 20, Czechia

Location

Unknown Facility

Ostrava, 708 52, Czechia

Location

Unknown Facility

Pilsen, 304 60, Czechia

Location

Unknown Facility

Prague, 100 34, Czechia

Location

Unknown Facility

Prague, 128 08, Czechia

Location

Unknown Facility

Prague, 150 06, Czechia

Location

Unknown Facility

Bialystok, 15-276, Poland

Location

Unknown Facility

Lublin, 20-090, Poland

Location

Related Publications (3)

• 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.

  PMID: 35898703 DERIVED

• 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.

  PMID: 35536547 DERIVED

• 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.

  PMID: 34992091 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Standard of Care; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Harald Fricke, MD, PhD

  SOTIO a.s.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 8, 2014
• Study Start: November 1, 2013
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2021
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

CZ (11); PL (2)