Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2)
NCT ID: NCT03393884
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
130 participants
INTERVENTIONAL
2018-09-05
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NACT + IMNN-001
The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. IMNN-001 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.
IMNN-001
IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer
Carboplatin
AUC 6 IV over 1 hour on Day 1 of each cycle
Paclitaxel
175 mg/m2 IV over 3 hours on Day 1 of each cycle
NACT Alone
The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.
Carboplatin
AUC 6 IV over 1 hour on Day 1 of each cycle
Paclitaxel
175 mg/m2 IV over 3 hours on Day 1 of each cycle
Interventions
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IMNN-001
IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer
Carboplatin
AUC 6 IV over 1 hour on Day 1 of each cycle
Paclitaxel
175 mg/m2 IV over 3 hours on Day 1 of each cycle
Eligibility Criteria
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Inclusion Criteria
2. Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.
3. 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.).
4. Patients must have adequate:
1. 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.
2. Renal function: Creatinine ≤1.5 x institutional upper limit normal (ULN).
3. Hepatic function: Bilirubin ≤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) ≤ 3.0 x ULN and alkaline phosphatase ≤ 2.5 x ULN.
4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.
5. Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.
6. 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.
7. Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.
8. 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.
9. Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.
10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.
11. Patients must be at least 18 years old.
Exclusion Criteria
2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to IMNN-001 or other agents used in this study.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. Patients with known active hepatitis.
9. 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.
10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.
11. 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.
12. 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.
18 Years
FEMALE
No
Sponsors
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Imunon
INDUSTRY
Responsible Party
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Principal Investigators
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Premal H. Thaker, M.D
Role: STUDY_CHAIR
Washington University School of Medicine
Locations
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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
Countries
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References
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Yin X, Davi R, Lamont EB, Thaker PH, Bradley WH, Leath CA 3rd, Moore KM, Anwer K, Musso L, Borys N. Historic Clinical Trial External Control Arm Provides Actionable GEN-1 Efficacy Estimate Before a Randomized Trial. JCO Clin Cancer Inform. 2023 Jan;7:e2200103. doi: 10.1200/CCI.22.00103.
Other Identifiers
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201-17-201
Identifier Type: -
Identifier Source: org_study_id