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

Phase 1

• Conditions: epithelial ovarian carcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002196-26-CZ
• Lead Sponsor: SOTIO a.s.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-25
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 30

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br>• Biological progression-free interval <br>• Best objective response <br>• Response <br>• Time to response <br>• Immunological response<br>• Safety<br>• Progression- free survival <br>• Progression- free survival in response sub-groups ;Primary end point(s): Progression- free survival<br>;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated after the End of Study

Secondary Outcome Measures

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