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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-23

Study Completion Date

2021-02-25

Brief Summary

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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)

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Detailed Description

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All patients who fulfill all eligibility criteria will undergo a leukapheresis procedure. All eligible/enrolled patients will receive standard-of-care therapy with carboplatin/gemcitabine or carboplatin/paclitaxel starting 2 to 7 days after leukapheresis.

After 6 cycles of chemotherapy, patients will start maintenance treatment with DCVAC/OvCa.

Treatment will continue irrespective of tumor progression until completion, refusal, intolerance of treatment or death.

Conditions

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Ovarian Cancer Recurrent

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

open-label DCVAC/OvCa after treatment with carboplatin in combination with either gemcitabine or paclitaxel

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of care chemotherapy + DCVAC/Ov

Standard-of-care carboplatin/gemcitabine or carboplatin/paclitaxel followed by DCVAC/OvCa

Group Type EXPERIMENTAL

DCVAC/OvCa

Intervention Type BIOLOGICAL

activated dendritic cells (DCVAC/OvCa) for immune maintenance after chemotherapy

Standard of Care Chemotherapy

Intervention Type DRUG

either carboplatin and gemcitabine or carboplatin and paclitaxel followed by DCVAC/OvCa

Interventions

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DCVAC/OvCa

activated dendritic cells (DCVAC/OvCa) for immune maintenance after chemotherapy

Intervention Type BIOLOGICAL

Standard of Care Chemotherapy

either carboplatin and gemcitabine or carboplatin and paclitaxel followed by DCVAC/OvCa

Intervention Type DRUG

Other Intervention Names

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carboplatin with gemcitabine carboplatin with paclitaxel

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No