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.
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 surgery (IDS). On the experimental arm, IMNN-001 at a dose of 100 mg/m2 will be administered IP on Days 8 and 15 of the first chemotherapy cycle and then on Days 1, 8, and 15 of all subsequent 5 chemotherapy cycles for a total of 17 treatments in the neoadjuvant and adjuvant settings. When given on the same day as chemotherapy, IMNN-001 should be given at least 30 minutes after completion of carboplatin infusion. IDS will take place after 3 cycles of neoadjuvant chemotherapy (NACT) + IMNN-001 for 8 doses. Additional cycles of NACT are allowed at the discretion of the investigator but with discussion with the medical monitor. An independent Data Monitoring Committee (iDMC) will monitor participants' safety and study conduct throughout the course of the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
100 mg/m2 IP given weekly during frontline treatment
175 mg/m2 IV given every 21 days for 6 cycles during frontline treatment
AUC 6 IV given every 21 days for 6 cycles during frontline treatment
Olaparib (300 mg orally every 12 hours for 2 years) for patients with somatic or germline BRCAmut.
Niraparib (200-300 mg orally daily for 3 years; dosing based on participant's weight and platelet counts) for either HRD/BRCAmut \& HRD/BRCAwt.
Advent Health
Orlando, Florida, United States
RECRUITINGWashington University School of Medicine in St. Louis
St Louis, Missouri, United States
RECRUITINGProvidence Cancer Institute
Portland, Oregon, United States
RECRUITINGSanford Health
Sioux Falls, South Dakota, United States
RECRUITINGErlanger Health
Chattanooga, Tennessee, United States
RECRUITINGProvidence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, United States
RECRUITINGFroedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
RECRUITINGOverall Survival
Overall Survival is defined as the time (in months) from the date of randomization to the date of death by any cause.
Time frame: 48 months
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.
Time frame: 12 weeks
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 frame: 12 weeks
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.
Time frame: 13 months
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.
Time frame: 12 weeks
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