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DCVAC/OvCa After Standard-of-care Chemotherapy in Women With Relapse of Platinum-sensitive Epithelial Ovarian Cancer

NCT03657966CompletedPHASE2INTERVENTIONAL

Summary

The purpose of this trial is to investigate if maintenance DCVAC/OvCa after second-line chemotherapy of carboplatin/gemcitabine or carboplatin/paclitaxel improves efficacy outcomes in women with FIGO stage III and IV epithelial ovarian carcinoma who experienced relapse more than 6 months after complete remission of first line platinum-based chemotherapy (platinum sensitive ovarian cancer)

Key Facts

Lead Sponsor

SOTIO a.s.

Enrollment

Start Date

2017-11-23

Completion Date

2020-11-11

Study Type

INTERVENTIONAL

Official Title

An Open-label, Single-group, Multi-center, 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 Cancer

Interventions

DCVAC/OvCaStandard of Care Chemotherapy

Conditions

Ovarian Cancer Recurrent

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Patients with histologically confirmed FIGO stage III or IV epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous,endometrioid, or mucinous) who had complete remission after first-line platinum-based chemotherapy
* Radiologically confirmed relapse after \>6 months of remission ( platinum-sensitive cancer)
* Laboratory parameters per protocol

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 (chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitory therapy, vascular endothelial growth factor or hormonal therapy) except first-line Pt based chemotherapy ( with or without bevacizumab)
* fertile women of child-bearing potential not willing to use a highly effective method of contraception or a combination of methods
* Pregnant of lactating women
* Pre-defined co-morbidities
* Known hypersensitivity to any constituent of DCVAC/OVCa or the selected chemotherapy compounds

Outcome Measures

Primary Outcomes

Progression Free Survival by modifications to the RECIST 1.1

PFS as defined as the time from the first dose of Standard-of-Care (SoC) therapy administerd until tumor progression or death from any cause

Time frame: Assessed from enrollment up to 104 weeks

Secondary Outcomes

Overall survival

Defined as the time from first dose of SoC therapy administered until death due to any cause assessed until study completion

Time frame: Assessed from enrolment through study completion approximately 5 years

Biological progression-free interval

Defined by increasing CA-125 levels per Gynecologic Cancer Intergroup (GCIG) criteria

Time frame: CA-125 assessed every 6 weeks up to 104 weeks

Objective Response rate

CR and PR measured by the modifed RECIST 1.1 criteria

Time frame: Response is assessed every 8 weeks up to 104 weeks

Immunologic Response

Detection of entire anti-tumor immune response int he serum

Time frame: Blood samples collected 5 times throughout the study from enrolment up to 104 weeks

Incidence of Treatment-emergent adverse events [safety and tolerability]

Safety profile as determined by the nature, incidence, duration, severity and outcome of adverse events (AEs) including serious AEs (SAEs) as assessed by CTCAE v. 4.0

Time frame: Screening through 30 days after completion of treatment

CA-125 response

Defined by GCIG criteria

Time frame: CA-125 assessed every 6 weeks up to 104 weeks

Time to either tumor or biologic Response

Response according to RECIST or CA-125 measurements as increased to \>2 times ULN

Time frame: From first dose of chemotherapy until either objective or serologic progression for up to 104 weeks.

Locations

University Hospital Brno, Brno, Czechia

Masaryk Memorial Cancer Institute, Brno, Czechia

Hospital Novy Jicin, Nový Jičín, Czechia

University Hospital in Ostrava, Ostrava, Czechia

University Hospital Plzen, Pilsen, Czechia

University Hospital Kralovsko Vinohrady, Prague, Czechia

General University Hospital in Prague, Prague, Czechia

Hospital Bulovka, Prague, Czechia