๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-01

Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2) (NCT03393884)

A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal IMNN-001 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

๐Ÿ”ต Active, Not Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Imunon

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal IMNN-001 plus NACT compared to NACT alone.

Who can join: Review the eligibility criteria below.

Location: University of Alabama Birmingham โ€” Birmingham, Alabama

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (21 Sites)

  • University of Alabama Birmingham โ€” Birmingham, Alabama
  • Mitchell Cancer Institute (University of South Alabama) โ€” Mobile, Alabama
  • Gynecologic Oncology Associates (Hoag Hospital) โ€” Newport Beach, California
  • Innovative Clinical Research โ€” Whittier, California
  • Advent Health โ€” Orlando, Florida
  • Women's Care Florida โ€” St. Petersburg, Florida
  • Massachusetts General Hospital โ€” Boston, Massachusetts
  • Washington University School of Medicine in St. Louis โ€” St Louis, Missouri
  • MD Anderson at Cooper โ€” Camden, New Jersey
  • Hackensack University Medical Center โ€” Hackensack, New Jersey
  • Monter Cancer Center โ€” Lake Success, New York
  • NYU Langone, Long Island โ€” Mineola, New York
  • NYU Langone โ€” New York, New York
  • Stephenson Cancer Center - Oklahoma University โ€” Oklahoma City, Oklahoma
  • Providence Cancer Institute โ€” Portland, Oregon
  • Sanford Health โ€” Sioux Falls, South Dakota
  • Chattanooga Women's Health โ€” Chattanooga, Tennessee
  • The West Clinic โ€” Germantown, Tennessee
  • Providence Health Care โ€” Spokane, Washington
  • Medical College of Wisconsin โ€” Milwaukee, Wisconsin
  • CHUM โ€” Montreal,

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—