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

Primary Purpose

Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Carcinoma

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

DCVAC/OvCa

DCVAC/OvCa placebo

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring active cellular immunotherapy, dendritic cells, platinum-sensitive, relapsed ovarian cancer, biologic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DCVAC/OvCa with standard of care

Placebo with standard of care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall Survival(OS)

Defined as the time from randomization until the date of death due to any cause.

Secondary Outcome Measures

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.

Objective Response Rate

Assessment of Objective Response Rate per RECIST1.1 until objective progression as defined by the Investigator.

Time to Relapse

Assessment of Time to Relapse, per objective progression according to RECIST 1.1.

Duration of Response

Assessment of Duration of Response until objective progression per RECIST 1.1.

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.

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.

Full Information

NCT ID

NCT03905902

First Posted

April 2, 2019

Last Updated

December 6, 2021

Sponsor

SOTIO a.s.

Collaborators

European Network of Gynaecological Oncological Trial Groups (ENGOT)

1. Study Identification

Unique Protocol Identification Number

NCT03905902

Brief Title

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

Acronym

VITALIA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Company decision

Study Start Date

August 2021 (Anticipated)

Primary Completion Date

August 2021 (Anticipated)

Study Completion Date

August 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SOTIO a.s.

Collaborators

European Network of Gynaecological Oncological Trial Groups (ENGOT)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Carcinoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

parallel-group, placebo-controlled

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

double-blind

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DCVAC/OvCa with standard of care

Arm Type

Experimental

Arm Description

Arm Title

Placebo with standard of care

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

DCVAC/OvCa

Other Intervention Name(s)

dendritic cell vaccine/ ovarian cancer

Intervention Description

activated autologous dendritic cells

Intervention Type

Biological

Intervention Name(s)

DCVAC/OvCa placebo

Intervention Description

placebo for activated autologous cells

Primary Outcome Measure Information:

Title

Overall Survival(OS)

Description

Defined as the time from randomization until the date of death due to any cause.

Time Frame

Assessed from enrolment up to study completion, approximately 6.6 years

Secondary Outcome Measure Information:

Title

Progression-Free Survival (PFS)

Description

Defined as the time from randomization to the earlier date of objective progression or death due to any cause in the absence of progression.

Time Frame

Assessed from enrollment to up to 4 years

Title

Objective Response Rate

Description

Assessment of Objective Response Rate per RECIST1.1 until objective progression as defined by the Investigator.

Time Frame

Assessed from start of treatment to up to 4 years

Title

Time to Relapse

Description

Assessment of Time to Relapse, per objective progression according to RECIST 1.1.

Time Frame

Assessed from start of treatment up to 4 years

Title

Duration of Response

Description

Assessment of Duration of Response until objective progression per RECIST 1.1.

Time Frame

Assessed from start of study treatment up to 4 years

Title

Biological Progression-Free Survival

Description

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.

Time Frame

Assessed from randomization up to study completion up to 6.6 years.

Title

Safety Assessments: NCI CTCAE version 5.0

Description

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.

Time Frame

Assessed from Screening through 30 days after the completion of Investigational Medicinal Product approximately 18 months.

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harald Fricke, MD PhD

Organizational Affiliation

SOTIO a.s.

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

David Cibula, Prof. MD PhD

Organizational Affiliation

The Central and Eastern European Gynecologic Oncology Group

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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