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Completed

NCT Number: NCT03657966

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

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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Key information

Conditions

Ovarian Cancer Recurrent Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Masaryk Memorial Cancer Institute, Brno, Czechia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DCVAC/OvCa

Biological

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

Standard of Care Chemotherapy

Drug

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

Other names: carboplatin with gemcitabine, carboplatin with paclitaxel

Primary outcomes

  1. Progression Free Survival by modifications to the RECIST 1.1

    Time frame: Assessed from enrollment up to 104 weeks

    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

Secondary outcomes

  1. Overall survival

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

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

  2. Biological progression-free interval

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

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

  3. Objective Response rate

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

    CR and PR measured by the modifed RECIST 1.1 criteria

  4. Immunologic Response

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

    Detection of entire anti-tumor immune response int he serum

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

    Time frame: Screening through 30 days after completion of treatment

    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

  6. CA-125 response

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

    Defined by GCIG criteria

  7. Time to either tumor or biologic Response

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

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

Sponsors and collaborators

Lead sponsor

SOTIO a.s.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Sep 5, 2018
Registry last updated
Apr 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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