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A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial DCVAC/OvCa Added to Standard Chemotherapy in Women With Relapsed Platinum Sensitive Epithelial Ovarian Carcinoma

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A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial DCVAC/OvCa Added to Standard Chemotherapy in Women With Relapsed Platinum Sensitive Epithelial Ovarian Carcinoma

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 12 Oct 2021

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At a glance

  • Drugs DCVAC OvCa (Primary) ; Carboplatin; Gemcitabine
  • Indications Adenocarcinoma; Carcinoma; Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
  • Focus Therapeutic Use
  • Sponsors SOTIO

    • Most Recent Events

    • 19 Jul 2021 To allow the replacement of patients who were randomized to the DCVAC/OvCa group but failed to receive at least one dose of DCVAC/OvCa and the randomization ratio was changed from 1:1 to 2.5:1 the trial protocol was amended so that an approximately equal number of patients in both groups in the primary analysis set as per results published in the Gynecologic Oncology
    • 19 Jul 2021 Primary endpoint (PFS (progression free survival)) has not been met as per results published in the Gynecologic Oncology
    • 19 Jul 2021 Results published in the Gynecologic Oncology

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