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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02107937
Enrollment
136
Registered
2014-04-08
Start date
2013-11-30
Completion date
2021-11-30
Last updated
2022-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Epithelial Cancer, Ovarian Neoplasms

Keywords

serous, endometrioid, mucinous, epithelial ovarian cancer

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).

Interventions

BIOLOGICALDCVAC/OvCa with Standard of Care

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

BIOLOGICALDCVAC/OvCa sequentially chemotherapy

DCVAC/OvCa added sequentially after Carboplatin and Paclitaxel

DRUGStandard of Care

Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy

Sponsors

SOTIO a.s.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Overall progression free survival (PFS)104 weeks

Secondary

MeasureTime frame
Proportion of patients in remission after first line chemotherapy at 12 months0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks
Biological progression free interval0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks
Immunological Response0, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60 weeks
Proportion of patients in remission after first line chemotherapy at 6 months0,10, 18, 30, 42 weeks
Frequency of Adverse Events0, 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
Time to 50 percent survival0, 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
Proportion of patients requiring 2nd line chemotherapy0, 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

Countries

Czechia, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026