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

SOTIO

Status and phase: Withdrawn; Phase 3

Conditions: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Carcinoma

Treatments: Biological: DCVAC/OvCa placebo; Biological: DCVAC/OvCa

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03905902

SOV09

VITALIA/ ENGOT-ov53 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

DCVAC/OvCa with standard of care

Experimental group

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

Treatment:

Biological: DCVAC/OvCa

Biological: DCVAC/OvCa placebo

Placebo with standard of care

Placebo Comparator group

Description:

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

Treatment:

Biological: DCVAC/OvCa

Biological: DCVAC/OvCa placebo