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

NCT03905902 | Withdrawn Phase 3 DMC

• 2 other identifiers: SOV09VITALIA/ ENGOT-ov53
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Progression-Free Survival (PFS)

  Assessed from enrollment to up to 4 years

• Objective Response Rate

  Assessed from start of treatment to up to 4 years

• Time to Relapse

  Assessed from start of treatment up to 4 years

• Duration of Response

  Assessed from start of study treatment up to 4 years

• Biological Progression-Free Survival

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

Study Arms (2)

DCVAC/OvCa with standard of care

EXPERIMENTAL

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; Biological: DCVAC/OvCa placebo

Placebo with standard of care

PLACEBO COMPARATOR

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; Biological: DCVAC/OvCa placebo

Interventions

DCVAC/OvCa BIOLOGICAL

activated autologous dendritic cells

Also known as: dendritic cell vaccine/ ovarian cancer

DCVAC/OvCa with standard of care; Placebo with standard of care

DCVAC/OvCa placebo BIOLOGICAL

placebo for activated autologous cells

DCVAC/OvCa with standard of care; Placebo with standard of care

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SOTIO a.s.: lead
• European Network of Gynaecological Oncological Trial Groups (ENGOT): collaborator

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Study Officials

• Harald Fricke, MD PhD

  SOTIO a.s.

  STUDY DIRECTOR

• David Cibula, Prof. MD PhD

  The Central and Eastern European Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: parallel-group, placebo-controlled

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 8, 2019
• Study Start: August 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 16, 2021
• Last Updated: December 23, 2021

Record last verified: 2021-12