Overview

This trial is active, not recruiting.

Conditions ovarian neoplasms, ovarian epithelial cancer
Treatments dcvac/ovca with standard of care, dcvac/ovca sequentially chemotherapy, standard of care
Phase phase 2
Sponsor Sotio a.s.
Start date November 2013
End date February 2018
Trial size 99 participants
Trial identifier NCT02107937, 2013-001322-26, SOV01

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
DCVAC/OvCa in parallel with chemotherapy (Standard of Care)
dcvac/ovca with standard of care Carboplatin
DCVAC/OvCa is the experimental therapy added on to Carboplatin and Paclitaxel
(Experimental)
DCVAC/OvCa sequentially after chemotherapy
dcvac/ovca sequentially chemotherapy Carboplatin
DCVAC/OvCa added sequentially after Carboplatin and Paclitaxel
(Active Comparator)
Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy
standard of care Carboplatin
Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy

Primary Outcomes

Measure
Overall progression free survival (PFS)
time frame: 104 weeks

Secondary Outcomes

Measure
Proportion of patients in remission after first line chemotherapy at 6 months
time frame: 0,10, 18, 30, 42 weeks
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
Biological progression free interval
time frame: 0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks
Immunological Response
time frame: 0, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60 weeks
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
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
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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

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
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).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Sotio a.s..