Clinical trial NCT03905902: DCVAC/OvCa and Standard of Care (SoC) in Relapsed Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma
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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Carcinoma
Keywords: active cellular immunotherapy
dendritic cells
platinum-sensitive
relapsed ovarian cancer
biologic
Lead sponsor: Sotio Biotech Inc.
Sponsor class: INDUSTRY
Collaborators: name: European Network of Gynaecological Oncological Trial Groups (ENGOT)
First posted: 2019-04-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel-group, placebo-controlled
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Overall Survival(OS)
timeFrame: Assessed from enrolment up to study completion, approximately 6.6 years
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Assessed from enrollment to up to 4 years
measure: Objective Response Rate
timeFrame: Assessed from start of treatment to up to 4 years
measure: Time to Relapse
timeFrame: Assessed from start of treatment up to 4 years
measure: Duration of Response
timeFrame: Assessed from start of study treatment up to 4 years
measure: Biological Progression-Free Survival
timeFrame: Assessed from randomization up to study completion up to 6.6 years.
measure: Safety Assessments: NCI CTCAE version 5.0
timeFrame: Assessed from Screening through 30 days after the completion of Investigational Medicinal Product approximately 18 months.
Other outcomes:
Locations:
Study officials:
affiliation: SOTIO a.s.
name: Harald Fricke, MD PhD
role: STUDY_DIRECTOR
affiliation: The Central and Eastern European Gynecologic Oncology Group
name: David Cibula, Prof. MD PhD
role: PRINCIPAL_INVESTIGATOR
References: