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.
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.
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.
Participants eligible to receive neoadjuvant chemotherapy.
Participants will provide a tumor tissue sample at pre-screening or screening, via laparoscopy or image guided core biopsy for determination of confirmed biomarker tumor status (HRD vs. HRP). See biomarker status definitions in the section below.
Participant who has received prior treatment with IMNN-001.
Participant who has received oral or parenteral corticosteroids (>10 mg prednisone) within 2 weeks of first dose of IMNN-001 (if applicable) or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.
Participant has mucinous, germ cell, transitional cell, clear cell, undifferentiated, or non-epithelial ovarian cancer.
Participant has low-grade or Grade 1 epithelial ovarian cancer.
Parallel
IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer)
Drug100 mg/m2 IP given weekly during frontline treatment
Paclitaxel
Drug175 mg/m2 IV given every 21 days for 6 cycles during frontline treatment
Carboplatin
DrugAUC 6 IV given every 21 days for 6 cycles during frontline treatment
Olaparib
DrugOlaparib (300 mg orally every 12 hours for 2 years) for patients with somatic or germline BRCAmut.
Niraparib
DrugNiraparib (200-300 mg orally daily for 3 years; dosing based on participant's weight and platelet counts) for either HRD/BRCAmut \& HRD/BRCAwt.
Overall Survival
Overall Survival is defined as the time (in months) from the date of randomization to the date of death by any cause.
Chemotherapy Response Score
After the interval debulking surgery takes place, participants will be assessed for a chemotherapy response score by the pathologist and scored based on CRS3, CRS2, or CRS1.
Surgical Response
After the interval debulking surgery takes place, participants are scored in terms of their interval debulking status with a score of R0, R1, or R2.
Time to Second Line Treatment
Time to second line treatment is defined as the time (in months) from the date of randomization to the date of second line chemotherapy treatment or death, whichever occurs first.
Objective Response Rate
Objective Response Rate is defined as the proportion of participants with objective evidence of CR or PR prior to IDS. The evaluation of objective response rate will be based on investigator (site) assessment of the images following RECIST v1.1 criteria.
