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

Study Overview
=================
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).

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

Conditions
-----------------
Ovarian Neoplasms, Ovarian Epithelial Cancer

Intervention / Treatment
-----------------
* Biological: DCVAC/OvCa with Standard of Care
* Biological: DCVAC/OvCa sequentially chemotherapy
* Drug: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCVAC/OvCa with Standard of Care<br>DCVAC/OvCa in parallel with chemotherapy (Standard of Care) | Biological: DCVAC/OvCa with Standard of Care<br>* DCVAC/OvCa is the experimental therapy added on to Carboplatin and Paclitaxel<br>* Other names: Paclitaxel;|
| Experimental: DCVAC/OvCa sequentially chemotherapy<br>DCVAC/OvCa sequentially after chemotherapy | Biological: DCVAC/OvCa sequentially chemotherapy<br>* DCVAC/OvCa added sequentially after Carboplatin and Paclitaxel<br>* Other names: Paclitaxel;|
| Active Comparator: Standart of Care<br>Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy | Drug: Standard of Care<br>* Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy<br>* Other names: Paclitaxel;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall progression free survival (PFS) |  | 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Biological progression free interval |  | 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
serous, endometrioid, mucinous, epithelial ovarian cancer