OVARIAN: NEOADJUVANT: Intraperitoneal IL12 and chemo: OVATION 2

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

Title
Celsion 201-17-201 (Neoadjv ovarian- OVATION)
Study Title

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

Site Link
Malignancy
Ovarian, fallopian tube, primary peritoneal
Stage
Disease Setting
Neoadjuvant
Line Of Therapy
Neoadjuvant
Investigational Agent
GEN-1
Drug Class
IL-12 plasmid formulated with PEG-PEI-Cholesterol Lipopolymer
PI
Adam ElNaggar, MD
Sponsor
Celsion
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies (laparoscopic or percutaneous)
  • Histologic documentation of the original primary tumor is required
  • FIGO Stage III-IV
  • Following histologic subtypes eligible: high grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma NOS.
  • ECOG PS 0-2
  • No need for treatment with immunosuppressive medication
  • No patients receiving treatment for active autoimmune disease
  • No known CNS involvement
  • No prior abdominal radiation or chemotherapy for abdominal or pelvic tumor
Objective
  • Primary
    • PFS
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
high grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma NOS
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
X