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

SOTIO a.s.

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Ovarian Cancer Fallopian Tube Cancer Peritoneal Carcinoma

Interventions

DCVAC/OvCaBIOLOGICAL

activated autologous dendritic cells

DCVAC/OvCa placeboBIOLOGICAL

placebo for activated autologous cells

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall Survival(OS)

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 Outcomes

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.

Time frame: Assessed from enrollment to up to 4 years

Objective Response Rate

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

Time to Relapse

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

Time frame: Assessed from start of treatment up to 4 years

Duration of Response

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

Time frame: Assessed from start of study treatment up to 4 years

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.

Time frame: Assessed from randomization up to study completion up to 6.6 years.

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.

Data from ClinicalTrials.gov

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