A Study of Maintenance DCVAC/OvCa After First-line Chemotherapy Added Standard of Care
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPeking University Third Hospital
About this trial
This is a randomized, double-blind, placebo-controlled,parallel-group preliminary verifying study about safety and efficacy of maintenance DCVAC/OvCa after first-line chemotherapy added to standard of care in patients with newly diagnosed FIGO III-IV ovarian, fallopian tube, or primary peritoneal carcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Eighteen years of age or older at the time written informed consent is obtained
Newly diagnosed, histologically confirmed FIGO stage III or IV EOC (high-grade serous or high-grade endometrioid)
After primary debulking surgery or after interval debulking surgery; residual disease after surgery with optimal resection as R0 or R1 (R0 is defined as no macroscopic residual disease, R1 is defined as macroscopic residual disease with a maximal diameter of <1 cm)
Known BRCA status; if BRCA mutation status not known, results of BRCA testing must be available before randomization
Disqualifiers
Non-epithelial ovarian carcinoma or mixed epithelial histology
Borderline tumors (tumors of low malignant potential)
First-line Pt-based adjuvant chemotherapy already started after surgery
Intention to treat with intraperitoneal chemotherapy
Trial design
Design model
Parallel
Treatments tested in this trial
DCVAC/OvCa
Combination productAn active cellular immunotherapy product containing autologous dendritic cells that are generated ex vivo from patient's monocytes and apoptotic tumor cells prepared from tumor cell lines
Placebo
Combination productPlacebo
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: DCVAC/OvCa armExperimental treatment 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Progress Free Survival
PFS defined as the time from randomization to the earlier date of assessment of objective progression or death by any cause in the absence of progression; progression will be assessed by the investigator per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Time frame
From randomization to the earlier date of assessment of objective progression or death by any cause in the absence of progression, the follow up period is about 2 years.Sponsors and contacts
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Peking University Third Hospital
Lead sponsor
SOTIO a.s.
Collaborator
Source ClinicalTrials.gov