Efficacy of DCVAC/OvCa Plus Standard of Care in Relapsed Platinum Resistant 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 may result in prolongation of Overall Survival (OS).

Detailed Description
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The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy may result in prolongation of Overall Survival (OS).

Official Title
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A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial Evaluating Effect of Addition of DCVAC/OvCa to Standard Chemotherapy in Women With Relapsed Platinum (Pt)-Resistant Epithelial Ovarian Carcinoma

Conditions
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Epithelial Ovarian Carcinoma

Intervention / Treatment
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* Biological: DCVAC/OvCa
* Drug: Standard of Care (Paclitaxel or topotecan or doxorubicin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females 18 years or older 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 have undergone initial surgery or interval debulking surgery but have not reached complete remission of more than 6 months after first line platinum based chemotherapy, for one of the following reasons Patients are platinum-refractory (no response) Complete remission was not reached (partial responders) Relapse within ≤6 months of remission (Platinum-resistant) Platinum-based chemotherapy failure should have been confirmed by computerized tomography (CT)/magnetic resonance imaging (MRI) scan (Platinum-resistant) or by finding described as 'did not reach complete clinical remission' (Platinum-refractory or Platinum-partial response) Patients must have at least one measureable target lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria Eastern Cooperative Oncology Group (ECOG) Performance status 0-2 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 Clinically significant cardiovascular disease Active autoimmune disease requiring treatment History of severe forms of primary immune deficiencies Systemic immunosuppressive therapy for any reason

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 chemo (SoC)<br>Combination therapy with DCVAC/OvCa and Standard of Care (SoC) | Biological: DCVAC/OvCa<br>* DCVAC/OvCa is the experimental therapy added on to Paclitaxel or topotecan or doxorubicin<br>|
| Active Comparator: Standard of Care (Chemotherapy)<br>Standard of Care as an Active Comparator (Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy) | Drug: Standard of Care (Paclitaxel or topotecan or doxorubicin)<br>* Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy<br>* Other names: doxorubicin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (all cause mortality) |  | 72 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Per modified RECIST | 72 weeks | 
| Objective Response Rate | Per RECIST | 0, 8, 16, ,24, 32, 40, 48, 56, 64, 72 weeks | 
| Biological Progression Free Interval |  | 0, 8, 16, 24, 32, 40, 48, 56, 64, 72 weeks | 
| Immunological Response |  | 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 weeks | 
| Frequency of Adverse Events |  | 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56, 64, 72 weeks | 
| Evaluation of Quality of Life via Functional Assessment of Cancer Therapy-Ovarian |  | 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 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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Serous, Immunotherapy, Relapsed, Platinum resistant (pt), Ovarian Cancer (OvCa), Biological, Vaccine