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

NCT ID: NCT03905902

Last Updated: 2021-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-31

Study Completion Date

2021-08-16

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

Conditions

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Ovarian Cancer Fallopian Tube Cancer Peritoneal Carcinoma

Keywords

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active cellular immunotherapy dendritic cells platinum-sensitive relapsed ovarian cancer biologic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel-group, placebo-controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
double-blind

Study Groups

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DCVAC/OvCa with standard of care

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

Group Type EXPERIMENTAL

DCVAC/OvCa

Intervention Type BIOLOGICAL

activated autologous dendritic cells

DCVAC/OvCa placebo

Intervention Type BIOLOGICAL

placebo for activated autologous cells

Placebo with standard of care

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

Group Type PLACEBO_COMPARATOR

DCVAC/OvCa

Intervention Type BIOLOGICAL

activated autologous dendritic cells

DCVAC/OvCa placebo

Intervention Type BIOLOGICAL

placebo for activated autologous cells

Interventions

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DCVAC/OvCa

activated autologous dendritic cells

Intervention Type BIOLOGICAL

DCVAC/OvCa placebo

placebo for activated autologous cells

Intervention Type BIOLOGICAL

Other Intervention Names

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dendritic cell vaccine/ ovarian cancer

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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European Network of Gynaecological Oncological Trial Groups (ENGOT)

OTHER

Sponsor Role collaborator

SOTIO a.s.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harald Fricke, MD PhD

Role: STUDY_DIRECTOR

SOTIO a.s.

David Cibula, Prof. MD PhD

Role: PRINCIPAL_INVESTIGATOR

The Central and Eastern European Gynecologic Oncology Group

Other Identifiers

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VITALIA/ ENGOT-ov53

Identifier Type: OTHER

Identifier Source: secondary_id

SOV09

Identifier Type: -

Identifier Source: org_study_id