DCVAC/OvCa After Standard-of-care Chemotherapy in Women With Relapse of Platinum-sensitive Epithelial Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to investigate if maintenance DCVAC/OvCa after second-line chemotherapy of carboplatin/gemcitabine or carboplatin/paclitaxel improves efficacy outcomes in women with FIGO stage III and IV epithelial ovarian carcinoma who experienced relapse more than 6 months after complete remission of first line platinum-based chemotherapy (platinum sensitive ovarian cancer)

Detailed Description
-----------------
All patients who fulfill all eligibility criteria will undergo a leukapheresis procedure. All eligible/enrolled patients will receive standard-of-care therapy with carboplatin/gemcitabine or carboplatin/paclitaxel starting 2 to 7 days after leukapheresis. After 6 cycles of chemotherapy, patients will start maintenance treatment with DCVAC/OvCa. Treatment will continue irrespective of tumor progression until completion, refusal, intolerance of treatment or death.

Official Title
-----------------
An Open-label, Single-group, Multi-center, Phase II Clinical Trial Evaluating the Effect of Maintenance DCVAC/OvCa After Standard-of-care Therapy in Women With First Relapse of Platinum-sensitive Epithelial Ovarian Cancer

Conditions
-----------------
Ovarian Cancer Recurrent

Intervention / Treatment
-----------------
* Biological: DCVAC/OvCa
* Drug: Standard of Care Chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically confirmed FIGO stage III or IV epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous,endometrioid, or mucinous) who had complete remission after first-line platinum-based chemotherapy Radiologically confirmed relapse after >6 months of remission ( platinum-sensitive cancer) Laboratory parameters per protocol Exclusion Criteria: FIGO I, II epithelial ovarian cancer FIGO III, IV clear cells epithelial ovarian cancer Non-epithelial ovarian cancer Borderline tumors ( tumors of low malignant potential) Prior or current systemic anti-cancer therapy for ovarian cancer (chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitory therapy, vascular endothelial growth factor or hormonal therapy) except first-line Pt based chemotherapy ( with or without bevacizumab) fertile women of child-bearing potential not willing to use a highly effective method of contraception or a combination of methods Pregnant of lactating women Pre-defined co-morbidities Known hypersensitivity to any constituent of DCVAC/OVCa or the selected chemotherapy compounds

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
Intervention Model: Single Group Assignment
Interventional Model Description: open-label DCVAC/OvCa after treatment with carboplatin in combination with either gemcitabine or paclitaxel
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard of care chemotherapy + DCVAC/Ov<br>Standard-of-care carboplatin/gemcitabine or carboplatin/paclitaxel followed by DCVAC/OvCa | Biological: DCVAC/OvCa<br>* activated dendritic cells (DCVAC/OvCa) for immune maintenance after chemotherapy<br>Drug: Standard of Care Chemotherapy<br>* either carboplatin and gemcitabine or carboplatin and paclitaxel followed by DCVAC/OvCa<br>* Other names: carboplatin with paclitaxel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival by modifications to the RECIST 1.1 | PFS as defined as the time from the first dose of Standard-of-Care (SoC) therapy administerd until tumor progression or death from any cause | Assessed from enrollment up to 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Defined as the time from first dose of SoC therapy administered until death due to any cause assessed until study completion | Assessed from enrolment through study completion approximately 5 years | 
| Biological progression-free interval | Defined by increasing CA-125 levels per Gynecologic Cancer Intergroup (GCIG) criteria | CA-125 assessed every 6 weeks up to 104 weeks | 
| Objective Response rate | CR and PR measured by the modifed RECIST 1.1 criteria | Response is assessed every 8 weeks up to 104 weeks | 
| Immunologic Response | Detection of entire anti-tumor immune response int he serum | Blood samples collected 5 times throughout the study from enrolment up to 104 weeks | 
| Incidence of Treatment-emergent adverse events [safety and tolerability] | Safety profile as determined by the nature, incidence, duration, severity and outcome of adverse events (AEs) including serious AEs (SAEs) as assessed by CTCAE v. 4.0 | Screening through 30 days after completion of treatment | 
| CA-125 response | Defined by GCIG criteria | CA-125 assessed every 6 weeks up to 104 weeks | 
| Time to either tumor or biologic Response | Response according to RECIST or CA-125 measurements as increased to >2 times ULN | From first dose of chemotherapy until either objective or serologic progression for up to 104 weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FIGO III, Immunotherapy, Platinum-sensitive, Biologic, Vaccine, Ovarian cancer, Fallopian Tube cancer, Primary peritoneal cancer, dendritic cells, chemotherapy, leukapheresis, FIGO IV