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

SOTIO

Status and phase: Completed; Phase 2

Conditions: Ovarian Neoplasms; Ovarian Epithelial Cancer

Treatments: Drug: Standard of Care; Biological: DCVAC/OvCa sequentially chemotherapy; Biological: DCVAC/OvCa with Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT02107937

SOV01

2013-001322-26 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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).

Enrollment: 136 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 3 patient groups

DCVAC/OvCa with Standard of Care

Experimental group

Description:

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

Treatment:

Biological: DCVAC/OvCa with Standard of Care

DCVAC/OvCa sequentially chemotherapy

Experimental group

Description:

DCVAC/OvCa sequentially after chemotherapy

Treatment:

Biological: DCVAC/OvCa sequentially chemotherapy

Standart of Care

Active Comparator group

Description:

Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy

Treatment:

Drug: Standard of Care