DCVAC/OvCa and Standard of Care (SoC) in Relapsed Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma

Study Overview
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Brief Summary
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Multi-center, phase III trial of DCVAC/OvCa added to standard of care treatments for relapsed ovarian cancer. Patients will receive study treatment until all doses are administered, or other criteria are met.

Detailed Description
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All patients who meet entry criteria will be randomized, and will undergo a leukapheresis procedure. During the Induction period, all patients will receive DCVAC/OvCa or placebo (study treatment) with concurrent standard-of-care platinum-based chemotherapy, with or without use of bevacizumab. In the Maintenance period, patients will continue treatment with study treatment in combination with bevacizumab, a poly (ADP-ribose) polymerase inhibitor (PARPi) or best supportive care only. Study treatment will continue irrespective of disease progression

Official Title
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A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of DCVAC/OvCa Added to Standard of Care in Patients With Relapsed Platinum-sensitive Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma

Conditions
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Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Carcinoma

Intervention / Treatment
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* Biological: DCVAC/OvCa
* Biological: DCVAC/OvCa placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed high-grade serous or endometrioid carcinoma of the ovary, peritoneum or fallopian tube. Without disease progression during preceding platinum-based chemotherapy Platinum-sensitive patients defined as Platinum-Free Interval of more than 6 months between the end of the last cycle of platinum-based chemotherapy and radiologic evidence of progression. First relapse identified by the criteria above up to 28 days prior to study randomization Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Known BRCA (breast cancer susceptibility gene) mutation status before randomization Patient is intended to be treated with bevacizumab, best supportive care (BSC) only or PARPi Exclusion Criteria: Tumor-specific: any other histology sub-type that is not high grade serous or endometrioid, however a combination of these is allowed Disease Treatment history: started or ongoing systemic treatment for current relapse of Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer before signing informed consent form (ICF), concomitant use of anti-neoplastic anti- hormonal therapy Intention to treat with intra-peritoneal chemotherapy

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
Interventional Model Description: parallel-group, placebo-controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCVAC/OvCa with standard of care<br>Induction period: DCVAC/OvCa with carboplatin and gemcitabine, or carboplatin and paclitaxel, or carboplatin and pegylated liposomal doxorubicin, with or without bevacizumab Maintenance period: DCVAC/OvCa with bevacizumab, best supportive care or a PARPi | Biological: DCVAC/OvCa<br>* activated autologous dendritic cells<br>* Other names: dendritic cell vaccine/ ovarian cancer;Biological: DCVAC/OvCa placebo<br>* placebo for activated autologous cells<br>|
| Placebo Comparator: Placebo with standard of care<br>Induction period: DCVAC Placebo with carboplatin and gemcitabine, or carboplatin and paclitaxel, or carboplatin and doxorubicin, with or without bevacizumab Maintenance Period:DCVAC placebo with bevacizumab, best supportive care or a PARPi carboplatin and gemcitabine or carboplatin and paclitaxel with or without bevacizumab, best supportive care or a PARPi | Biological: DCVAC/OvCa<br>* activated autologous dendritic cells<br>* Other names: dendritic cell vaccine/ ovarian cancer;Biological: DCVAC/OvCa placebo<br>* placebo for activated autologous cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival(OS) | Defined as the time from randomization until the date of death due to any cause. | Assessed from enrolment up to study completion, approximately 6.6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) | Defined as the time from randomization to the earlier date of objective progression or death due to any cause in the absence of progression. | Assessed from enrollment to up to 4 years | 
| Objective Response Rate | Assessment of Objective Response Rate per RECIST1.1 until objective progression as defined by the Investigator. | Assessed from start of treatment to up to 4 years | 
| Time to Relapse | Assessment of Time to Relapse, per objective progression according to RECIST 1.1. | Assessed from start of treatment up to 4 years | 
| Duration of Response | Assessment of Duration of Response until objective progression per RECIST 1.1. | Assessed from start of study treatment up to 4 years | 
| Biological Progression-Free Survival | Defined as the time from randomization to the earlier date of assessment of biological progression evaluated by increasing CA 125 levels or death due to any cause in the absence of progression. | Assessed from randomization up to study completion up to 6.6 years. | 
| Safety Assessments: NCI CTCAE version 5.0 | Defined as the incidence, severity and outcome of treatment emergent adverse events (TEAEs), and serious adverse events (SAEs) assessed by NCI CTCAE version 5.0. | Assessed from Screening through 30 days after the completion of Investigational Medicinal Product approximately 18 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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active cellular immunotherapy, dendritic cells, platinum-sensitive, relapsed ovarian cancer, biologic