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

Ovarian Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03905902
• Other study ID #: SOV09
• Secondary ID: VITALIA/ ENGOT-o
• Status: Withdrawn
• Phase: Phase 3
• Start date: August 2021
• Est. completion date: August 16, 2021

Study information

• Verified date: December 2021
• Source: SOTIO Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 16, 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Carcinoma

Intervention

Biological:
• DCVAC/OvCa
activated autologous dendritic cells
• DCVAC/OvCa placebo
placebo for activated autologous cells

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
SOTIO a.s.	European Network of Gynaecological Oncological Trial Groups (ENGOT)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.