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

Ovarian Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02107937
• Other study ID #: SOV01
• Secondary ID: 2013-001322-26
• Status: Completed
• Phase: Phase 2
• Start date: November 2013
• Est. completion date: November 2021

Study information

• Verified date: May 2022
• Source: SOTIO Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: November 2021
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Epithelial Cancer
• Ovarian Neoplasms

Intervention

Biological:
• DCVAC/OvCa with Standard of Care
DCVAC/OvCa is the experimental therapy added on to Carboplatin and Paclitaxel
• DCVAC/OvCa sequentially chemotherapy
DCVAC/OvCa added sequentially after Carboplatin and Paclitaxel

Drug:
• Standard of Care
Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SOTIO a.s.

Countries where clinical trial is conducted

Czechia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall progression free survival (PFS)		104 weeks
Secondary	Proportion of patients in remission after first line chemotherapy at 6 months		0,10, 18, 30, 42 weeks
Secondary	Proportion of patients in remission after first line chemotherapy at 12 months		0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks
Secondary	Biological progression free interval		0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks
Secondary	Immunological Response		0, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60 weeks
Secondary	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
Secondary	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
Secondary	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