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

December 6, 2021 updated by: SOTIO a.s.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Biological: DCVAC/OvCa
activated autologous dendritic cells
Other Names:
  • dendritic cell vaccine/ ovarian cancer
Biological: DCVAC/OvCa placebo
placebo for activated autologous cells
Placebo Comparator: 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
Biological: DCVAC/OvCa
activated autologous dendritic cells
Other Names:
  • dendritic cell vaccine/ ovarian cancer
Biological: DCVAC/OvCa placebo
placebo for activated autologous cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival(OS)
Time Frame: Assessed from enrolment up to study completion, approximately 6.6 years
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)
Time Frame: Assessed from enrollment to up to 4 years
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
Time Frame: Assessed from start of treatment to up to 4 years
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
Time Frame: Assessed from start of treatment up to 4 years
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
Time Frame: Assessed from start of study treatment up to 4 years
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
Time Frame: Assessed from randomization up to study completion up to 6.6 years.
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
Time Frame: Assessed from Screening through 30 days after the completion of Investigational Medicinal Product approximately 18 months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SOTIO a.s.

Collaborators

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Investigators

  • Study Director: Harald Fricke, MD PhD, SOTIO a.s.
  • Principal Investigator: David Cibula, Prof. MD PhD, The Central and Eastern European Gynecologic Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Actual)

August 16, 2021

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 4, 2019

First Posted (Actual)

April 8, 2019

Study Record Updates

Last Update Posted (Actual)

December 23, 2021

Last Update Submitted That Met QC Criteria

December 6, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOV09
  • VITALIA/ ENGOT-ov53 (Other Identifier: ENGOT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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