Phase II Study DCVAC/OvCa Plus Carboplatin Gemcitabine Relapsed Platinum (Pt)-Sensitive Epithelial Ovarian Carcinoma

Study Overview
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Brief Summary
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The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).

Detailed Description
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The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).

Official Title
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A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial DCVAC/OvCa Added to Standard Chemotherapy in Women With Relapsed Platinum Sensitive Epithelial Ovarian Carcinoma

Conditions
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Ovarian Neoplasms, Ovarian Cancer (OvCa), Ovarian Epithelial Cancer

Intervention / Treatment
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* Biological: DCVAC/OvCa in parallel with chemotherapy
* Drug: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females 18 years old and older Patients with histologically confirmed, International Federation of Gynecology and Obstetrics (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 (Pt)-based chemotherapy and are selected to receive second line Standard of Care chemotherapy Radiologically confirmed relapse after >6 months of remission (Platinum-sensitive patients), found up to 4 weeks prior study entry. The patient must have at least one measureable target lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria to be eligible for enrolment in the study 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 [for example chemotherapy, monoclonal antibody therapy , tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy] except first line Platinum-based chemotherapy (with or without bevacizumab) Previous 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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 in parallel with chemotherapy<br>Combination therapy with DCVAC/OvCa and Standard of Care | Biological: DCVAC/OvCa in parallel with chemotherapy<br>* DCVAC/OvCa is the experimental therapy added on to Carboplatin and Gemcitabine<br>* Other names: carboplatin and gemcitabine;|
| Active Comparator: Standard of Care<br>Standard of Care carboplatin and gemcitabine | Drug: Standard of Care<br>* Carboplatin and Gemcitabine is Standard of Care First Line Chemotherapy<br>* Other names: Carboplatin and Gemcitabine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine median progression free survival |  | 72 Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (all causes) |  | 56, 64, 72 weeks | 
| Objective Response Rate |  | 8, 16, 24, 32, 40, 48, 56. 64. 72 weeks | 
| Biological Progression Free Interval |  | 6, 12, 18, 24, 36, 42, 48, 56, 64, 72 weeks | 
| Immunological Response |  | 24, 48, 72 weeks | 
| Frequency of adverse events |  | 8, 16, 24, 32, 40, 48, 56. 64. 72 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian, Platinum Sensitive, Epithelial