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A Randomized Phase III Trial Evaluating the Safety and Efficacy of Intraperitoneal IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) Administered in Combination with Standard Neoadjuvant and Adjuvant Chemotherapy in Newly Diagnosed Patients with Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
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Status: Recruiting
The purpose of this research is to learn more about whether IMNN-001 combined with standard chemotherapy is safe and effective for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer, compared to standard chemotherapy alone.
Sex: Female
Age Group: 18 years and over
Inclusion Criteria:
• ages 18 years of age or older
• diagnosed with advanced high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer (Stage IIIB/C or IV)
• eligible to receive chemotherapy before surgery
• willing and able to provide a tumor tissue sample for biomarker testing
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:
• prior treatment for high-grade ovarian, fallopian tube, or primary peritoneal cancer
• pregnant, breastfeeding, or inability to use required contraception
• see link to clinicaltrials.gov for complete Exclusion criteria
Interventions:
Drug: Carboplatin, Drug: IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer), Drug: Niraparib, Drug: Olaparib, Drug: Paclitaxel
Conditions:
Cancer
Keywords:
Clinics and Surgery Center (CSC), fallopian tube cancer, Ovarian cancer, Primary Peritoneal cancer
Study Contact: Melissa Geller - gelle005@umn.edu
Principal Investigator: Melissa Geller, MD
Phase: PHASE3
IRB Number: STUDY00027578
See this study on ClinicalTrials.gov