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A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Trial Profile

A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 18 Nov 2019

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At a glance

  • Drugs GEN 1 (Primary) ; Carboplatin; Paclitaxel
  • Indications Adenocarcinoma; Carcinoma; Endometrial cancer; Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
  • Focus Therapeutic Use
  • Acronyms OVATION 2; OVATION II
  • Sponsors Celsion Corporation
  • Most Recent Events

    • 08 Nov 2019 According to a Celsion Corporation media release, the company will host a conference call to discuss OPTIMA and OVATION 2 studies on Friday, November 15, 2019.
    • 05 Nov 2019 According to a Celsion Corporation media release, the company looks forward to presenting surgical results, overall response rates and translational data as it becomes available this quarter.
    • 05 Nov 2019 According to a Celsion Corporation media release, the independent Data Safety Monitoring Board (DSMB) has completed its safety review of data from the first eight patients enrolled in this ongoing study. Based on the DSMB's recommendation, the study will continue as planned and the Company will proceed with completing enrollment in the Phase I portion of the trial.
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