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

Phase 2

Completed

• Conditions: Ovarian Epithelial Cancer; Ovarian Neoplasms
• Interventions: Biological: DCVAC/OvCa with Standard of Care; Biological: DCVAC/OvCa sequentially chemotherapy; Drug: Standard of Care

• Registration Number: NCT02107937
• Lead Sponsor: SOTIO a.s.

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).

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-08
• Primary Completion: 2020-11
• Study Completion: 2021-11
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DCVAC/OvCa with Standard of Care	DCVAC/OvCa with Standard of Care	DCVAC/OvCa in parallel with chemotherapy (Standard of Care)
DCVAC/OvCa sequentially chemotherapy	DCVAC/OvCa sequentially chemotherapy	DCVAC/OvCa sequentially after chemotherapy
Standart of Care	Standard of Care	Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy

Primary Outcome Measures

Name	Time	Method
Overall progression free survival (PFS)	104 weeks

Secondary Outcome Measures

Name	Time	Method
Biological progression free interval	0,10, 18, 30, 42, 54, 68, 80, 92, 104 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
Frequency of Adverse Events	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
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
Immunological Response	0, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60 weeks
Time to 50 percent survival	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