RecruitingPhase 3NCT06915025

Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer

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


Sponsor

Imunon

Enrollment

500 participants

Start Date

Jul 9, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called IMNN-001 combined with standard chemotherapy for women newly diagnosed with advanced ovarian, fallopian tube, or peritoneal cancer. Researchers want to see if adding IMNN-001 makes the treatment safer and more effective. **You may be eligible if...** - You are a woman aged 18 or older - You have recently been diagnosed with advanced high-grade ovarian, fallopian tube, or peritoneal cancer (Stage IIIB, IIIC, or IV) - You are a candidate for chemotherapy before surgery (called neoadjuvant chemotherapy) - Your blood counts, kidney, liver, and nerve function are within acceptable ranges - You are willing to use effective contraception if you could become pregnant **You may NOT be eligible if...** - You have mucinous, clear cell, or low-grade ovarian cancer - You have received prior treatment for this cancer - You are currently pregnant or breastfeeding - You are taking high-dose steroids or immunosuppressant medications - You have a bowel obstruction or active serious infection - You have been treated for another invasive cancer within the last 3 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Health

Orlando, Florida, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

Providence Cancer Institute

Portland, Oregon, United States

Sanford Health

Sioux Falls, South Dakota, United States

Erlanger Health

Chattanooga, Tennessee, United States

Providence Sacred Heart Medical Center & Children's Hospital

Spokane, Washington, United States

Froedtert and The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06915025


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