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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

In brief

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.

Key facts

Study ID

NCT03393884

Run by

Imunon

People needed

130

Starts

2018-09-05

Expected to finish

2026-05-30

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have suspected histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.
• Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.
• Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).
• Patients must have adequate:
• Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.
• Renal function: Creatinine ≤1.5 x institutional upper limit normal (ULN).
• Hepatic function: Bilirubin ≤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) ≤ 3.0 x ULN and alkaline phosphatase ≤ 2.5 x ULN.
• Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.
• Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.
• Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.
• Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.
• Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.
• Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.
• Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.
• Patients must be at least 18 years old.

You may not qualify if…

• Patients who have received prior treatment with IMNN-001.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to IMNN-001 or other agents used in this study.
• Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.
• Patients receiving treatment for active autoimmune disease. "Active" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.
• Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
• Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
• Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.
• Patients with known active hepatitis.
• Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.
• Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.
• Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.
• Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.

Where it is running

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

Full record on ClinicalTrials.gov

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