NCT06915025 · Imunon
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
(OVATION-3)
What this study is about
This is a randomly assigned, adaptive, open label, conducted at multiple hospitals trial to evaluate the safety and effectiveness of intraperitoneal (IP) IMNN-001 plus chemotherapy compared to chemotherapy alone.
View original scientific description
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.
Interventions
DRUG
IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer)
100 mg/m2 IP given weekly during frontline treatment
DRUG
Paclitaxel
175 mg/m2 IV given every 21 days for 6 cycles during frontline treatment
DRUG
Carboplatin
AUC 6 IV given every 21 days for 6 cycles during frontline treatment
DRUG
Olaparib
Olaparib (300 mg orally every 12 hours for 2 years) for patients with somatic or germline BRCAmut.
DRUG
Niraparib
Niraparib (200-300 mg orally daily for 3 years; dosing based on participant's weight and platelet counts) for either HRD/BRCAmut \& HRD/BRCAwt.
Primary outcome measures
Overall Survival
Time frame: 48 months
Overall Survival is defined as the time (in months) from the date of randomization to the date of death by any cause.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants must be female, ≥18 years of age, able to understand the study procedures, and agree to participate in the study by providing written informed consent. 2. Participants with a histologically confirmed diagnosis of high-grade non-mucinous epithelial ovarian (serous, endometrioid, carcinosarcoma, mixed epithelial pathologies), fallopian tube or peritoneal cancer that is Stage IIIB/C or IV according to the International Federation of Gynecology and Obstetrics (FIGO) or tumor, node and metastasis staging criteria. 3. Participants eligible to receive neoadjuvant chemotherapy. 4. Participants will provide a tumor tissue sample at pre-screening or screening, via laparoscopy or image guided core biopsy for determination of confirmed biomarker tumor status (HRD vs. HRP). See biomarker status definitions in the section below. 5. Participants of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin) within 14 days p
Where
- Orlando, Florida
- Minneapolis, Minnesota
- St Louis, Missouri
- Portland, Oregon
- Sioux Falls, South Dakota
- Chattanooga, Tennessee
- Spokane, Washington
- Milwaukee, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations