Evaluation of DCVAC/OvCa (cancer immunotherapy) administered after standard cancer treatment in women with ovarian carncer

An open-label, single-group, multicenter phase II clinical trial evaluating the effect of maintenance DCVAC/OvCa after standard of care therapy in women with first relapse of platinum-sensitive epithelial ovarian carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002196-26-CZ

Enrollment

Registered

2017-07-25

Start date

2017-09-21

Completion date

Unknown

Last updated

2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

epithelial ovarian carcinoma

Interventions

Product Name: DCVAC/OvCa Pharmaceutical Form: Suspension for injection INN or Proposed INN: DCVAC/OvCa Current Sponsor code: DCVAC/OvCa Other descriptive name: CELL SUSPENSION CONTAINING DENDRITIC CEL

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Female aged =18 years - Patients with histologically confirmed FIGO stage III and IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma - Radiologically confirmed relapse after >6 months of remission - Laboratory parameters per protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: - FIGO I, II epithelial ovarian cancer - FIGO III, IV clear cells epithelial ovarian cancer - Non-epithelial ovarian cancer - Borderline tumors (tumors of low malignant potential) - Prior or current systemic anti-cancer therapy for ovarian cancer except first line Pt based chemotherapy (with or without bevacizumab) - Pre-defined co-morbidities - Known hypersensitivity to any constituent of DCVAC/OvCa or the selected chemotherapy compounds - Fertile woman of childbearing potential not willing to use a highly effective method of contraception or combination of methods - Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this trial is to explore added efficacy when adding DCVAC/OvCa as maintenance treatment after SoC therapy with carboplatin/gemcitabine or carboplatin/paclitaxel in women with ovarian cancer who experienced relapse >6 months after complete remission following Pt-based first-line chemotherapy;Secondary Objective: • Overal survival • Biological progression-free interval • Best objective response • Response • Time to response • Immunological response • Safety • Progression- free survival • Progression- free survival in response sub-groups ;Primary end point(s): Progression- free survival ;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated after the End of Study	—

Measure

Time frame

Main Objective: The primary objective of this trial is to explore added efficacy when adding DCVAC/OvCa as maintenance treatment after SoC therapy with carboplatin/gemcitabine or carboplatin/paclitaxel in women with ovarian cancer who experienced relapse >6 months after complete remission following Pt-based first-line chemotherapy;Secondary Objective: • Overal survival • Biological progression-free interval • Best objective response • Response • Time to response • Immunological response • Safety • Progression- free survival • Progression- free survival in response sub-groups ;Primary end point(s): Progression- free survival ;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated after the End of Study

—

Secondary

Measure	Time frame
Secondary end point(s): - Overall survival - Biological progression-free interval - Objective response rate - Time to response - Immunological response - Safety endpoint;Timepoint(s) of evaluation of this end point: Secondary endpoints will be evaluated after the End of Study	—

Countries

Czech Republic

Contacts

Public ContactClinical Trial SOTIO

SOTIO a.s.

clinicaltrial@sotio.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026