A Randomized Phase 3 Trial Evaluating the Safety & Efficacy of IP IMNN-001 Administered in Combination w/ Standard Neoadjuvant & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer
Imunon
Summary
This is a randomized, adaptive, open label, multicenter trial to evaluate the safety and efficacy of intraperitoneal (IP) IMNN-001 plus chemotherapy compared to chemotherapy alone.
Description
Eligible participants will be randomly assigned 1:1 to receive either chemotherapy plus IMNN-001 or chemotherapy alone, followed by standard of care maintenance therapy. Randomization will stratify by confirmed biomarker tumor homologous recombination deficiency status and stage of cancer. On both arms, the chemotherapy regimen will consist of paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1 of each cycle. This will be repeated every 3 weeks for a total of 6 cycles, 3 in the neoadjuvant period and 3 in the adjuvant period following interval debulking…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants must be female, ≥18 years of age, able to understand the study procedures, and agree to participate in the study by providing written informed consent. 2. Participants with a histologically confirmed diagnosis of high-grade non-mucinous epithelial ovarian (serous, endometrioid, carcinosarcoma, mixed epithelial pathologies), fallopian tube or peritoneal cancer that is Stage IIIB/C or IV according to the International Federation of Gynecology and Obstetrics (FIGO) or tumor, node and metastasis staging criteria. 3. Participants eligible to receive neoadjuvant…
Interventions
- DrugIMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer)
100 mg/m2 IP given weekly during frontline treatment
- DrugPaclitaxel
175 mg/m2 IV given every 21 days for 6 cycles during frontline treatment
- DrugCarboplatin
AUC 6 IV given every 21 days for 6 cycles during frontline treatment
- DrugOlaparib
Olaparib (300 mg orally every 12 hours for 2 years) for patients with somatic or germline BRCAmut.
- DrugNiraparib
Niraparib (200-300 mg orally daily for 3 years; dosing based on participant's weight and platelet counts) for either HRD/BRCAmut \& HRD/BRCAwt.
Locations (7)
- Advent HealthOrlando, Florida
- Washington University School of Medicine in St. LouisSt Louis, Missouri
- Providence Cancer InstitutePortland, Oregon
- Sanford HealthSioux Falls, South Dakota
- Erlanger HealthChattanooga, Tennessee
- Providence Sacred Heart Medical Center & Children's HospitalSpokane, Washington