Epithelial Ovarian CancerPhase 1/2OVATION 2NCT03393884
Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2)
A Phase 1/2 study testing IMNN-001, Carboplatin and Paclitaxel in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Imunon at 21 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- What is being tested?
- IMNN-001, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 5 Sep 2018to 30 May 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 15Show fewer
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States20 sites
University of Alabama Birmingham
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
MD Anderson at Cooper
Camden, New Jersey, 08105
Chattanooga Women's Health
Chattanooga, Tennessee, 37403
The West Clinic
Germantown, Tennessee, 38138
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Monter Cancer Center
Lake Success, New York, 11042
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
NYU Langone, Long Island
Mineola, New York, 11501
Mitchell Cancer Institute (University of South Alabama)
Mobile, Alabama, 36604
NYU Langone
New York, New York, 10016
Gynecologic Oncology Associates (Hoag Hospital)
Newport Beach, California, 92663
Stephenson Cancer Center - Oklahoma University
Oklahoma City, Oklahoma, 73104
Advent Health
Orlando, Florida, 32803
Providence Cancer Institute
Portland, Oregon, 97213
Sanford Health
Sioux Falls, South Dakota, 57104
Providence Health Care
Spokane, Washington, 99204
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
Women's Care Florida
St. Petersburg, Florida, 33701
Innovative Clinical Research
Whittier, California, 90603
About this study
Official title: 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
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.
- Being tested
- IMNN-001, Carboplatin, Paclitaxel
- Keywords
- GEN-1, IMNN-001
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMNN-001Biological
IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer
CarboplatinDrug
AUC 6 IV over 1 hour on Day 1 of each cycle
PaclitaxelDrug
175 mg/m2 IV over 3 hours on Day 1 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| NACT + IMNN-001 | Experimental | 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. Receives: Biological: IMNN-001; Drug: Carboplatin; Drug: Paclitaxel |
| NACT Alone | Active comparator | 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. Receives: Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus IMNN-001 versus standard NACT.
Measured: The primary analysis for PFS will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.
Secondary outcomes (1)
Overall Survival
Overall survival is defined as the time (in months) from the date of randomization to the date of death.
Measured: Randomization to date of death, for up to 3 years from LPI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start5 Sep 2018
- Primary completion25 Jul 2024
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imunon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Premal H. Thaker, M.D, Study chair, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393884
- Sponsor's protocol ID
- 201-17-201
- Acronym
- OVATION 2
- Status last verified
- May 2026
- First submitted
- 3 Jan 2018
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thaker PH, Richardson DL, Hagemann AR, Holloway RW, Reed M, Bergman MK, Pothuri B, DePasquale S, Scalici JM, Bregar AJ, Darus CJ, Finkelstein K, Leath CA 3rd, Bell M, Warshal DP, Agajanian R, Indermaur MD, Mendivil AA, Provencher DM, Wei LJ, Borys N, Musso L, Lindborg SR, Faller DV, Anwer K, Bradley WH. OVATION-2: A randomized phase I/II study evaluating the safety and efficacy of IMNN-001 (IL-12 gene therapy) with neo/adjuvant chemotherapy in patients newly-diagnosed with advanced epithelial ovarian cancer. Gynecol Oncol. 2025 Jun;197:182-191. doi: 10.1016/j.ygyno.2025.04.578. Epub 2025 Jun 3.
PubMed 40461366Yin 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.
PubMed 36608308
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03393884
- Acronym / sponsor ID
- OVATION 2 / 201-17-201
- Keywords
- GEN-1, IMNN-001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- ImunonIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 9 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NACT + IMNN-001 | Experimental | Biological: IMNN-001, Drug: Carboplatin, Drug: PaclitaxelThe 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. |
| NACT Alone | Active comparator | Drug: Carboplatin, Drug: PaclitaxelThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMNN-001IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer | Biological | NACT + IMNN-001 |
| CarboplatinAUC 6 IV over 1 hour on Day 1 of each cycle | Drug | NACT + IMNN-001, NACT Alone |
| Paclitaxel175 mg/m2 IV over 3 hours on Day 1 of each cycle | Drug | NACT + IMNN-001, NACT Alone |
Primary outcome
PFS
Time frame: The primary analysis for PFS will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.
The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus IMNN-001 versus standard NACT.
1 secondary outcome
Overall Survival
Time frame: Randomization to date of death, for up to 3 years from LPI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 40461366Thaker PH, Richardson DL, Hagemann AR, Holloway RW, Reed M, Bergman MK, Pothuri B, DePasquale S, Scalici JM, Bregar AJ, Darus CJ, Finkelstein K, Leath CA 3rd, Bell M, Warshal DP, Agajanian R, Indermaur MD, Mendivil AA, Provencher DM, Wei LJ, Borys N, Musso L, Lindborg SR, Faller DV, Anwer K, Bradley WH. OVATION-2: A randomized phase I/II study evaluating the safety and efficacy of IMNN-001 (IL-12 gene therapy) with neo/adjuvant chemotherapy in patients newly-diagnosed with advanced epithelial ovarian cancer. Gynecol Oncol. 2025 Jun;197:182-191. doi: 10.1016/j.ygyno.2025.04.578. Epub 2025 Jun 3.
- Derived from this study: PubMed 36608308Yin 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.
- Individual participant dataSharing planned: No
Related trials for Epithelial Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 3
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Epithelial Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Premal H. Thaker, M.D study chair
Washington University School of Medicine
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMNN-001, Carboplatin and Paclitaxel in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Imunon at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: The primary analysis for PFS will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03393884, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.