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

NCT06915025 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 201-24-301
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Primary Peritoneal Carcinoma; Ovarian Cancer; Fallopian Tube Cancer; Epithelial Ovarian Cancer

Keywords

IMNN-001; GEN-1; OVATION-3

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall Survival is defined as the time (in months) from the date of randomization to the date of death by any cause.

  48 months

Secondary Outcomes (4)

• Chemotherapy Response Score

  12 weeks

• Surgical Response

  12 weeks

• Time to Second Line Treatment

  13 months

• Objective Response Rate

  12 weeks

Study Arms (2)

Experimental Arm: IMNN-001 + SOC Chemotherapy + SOC Maintenance Therapy

EXPERIMENTAL

IMNN-001 in combination with standard neoadjuvant and adjuvant chemotherapy followed by standard of care maintenance therapy

Drug: IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer); Drug: Paclitaxel; Drug: Carboplatin; Drug: Olaparib; Drug: Niraparib

Control Arm: SOC Chemotherapy + SOC Maintenance Therapy

ACTIVE COMPARATOR

Standard neoadjuvant and adjuvant chemotherapy followed by standard of care maintenance therapy.

Drug: Paclitaxel; Drug: Carboplatin; Drug: Olaparib; Drug: Niraparib

Interventions

Paclitaxel DRUG

175 mg/m2 IV given every 21 days for 6 cycles during frontline treatment

Control Arm: SOC Chemotherapy + SOC Maintenance Therapy; Experimental Arm: IMNN-001 + SOC Chemotherapy + SOC Maintenance Therapy

Carboplatin DRUG

AUC 6 IV given every 21 days for 6 cycles during frontline treatment

Control Arm: SOC Chemotherapy + SOC Maintenance Therapy; Experimental Arm: IMNN-001 + SOC Chemotherapy + SOC Maintenance Therapy

Olaparib DRUG

Olaparib (300 mg orally every 12 hours for 2 years) for patients with somatic or germline BRCAmut.

Also known as: Lynparza

Control Arm: SOC Chemotherapy + SOC Maintenance Therapy; Experimental Arm: IMNN-001 + SOC Chemotherapy + SOC Maintenance Therapy

Niraparib DRUG

Niraparib (200-300 mg orally daily for 3 years; dosing based on participant's weight and platelet counts) for either HRD/BRCAmut \& HRD/BRCAwt.

Also known as: Zejula

Control Arm: SOC Chemotherapy + SOC Maintenance Therapy; Experimental Arm: IMNN-001 + SOC Chemotherapy + SOC Maintenance Therapy

IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) DRUG

100 mg/m2 IP given weekly during frontline treatment

Also known as: GEN-1

Experimental Arm: IMNN-001 + SOC Chemotherapy + SOC Maintenance Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Participants eligible to receive neoadjuvant chemotherapy.
• 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.
• Participants of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin) within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, participants must discontinue breastfeeding prior to study entry.
• Participants must have adequate:
• Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/µl. Exceptions may be made in patients with benign ethnic neutropenia \>800/ul with approval of a medical monitor. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/µl.
• Renal function: eGFR \> 60 ml/min/1.73m2
• Hepatic function: Bilirubin ≤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) ≤ 3.0 x ULN and alkaline phosphatase ≤ 2.5 x ULN. Exceptions due to hepatic metastases can be considered in consultation with medical monitor.
• Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1 as defined by CTCAE version 5.0.
• Participants must have an ECOG score of 0, 1 or 2.
• Participants should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within 4 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.

You may not qualify if:

• Participant who has received prior treatment with IMNN-001.
• Participant who has received oral or parenteral corticosteroids (\>10 mg prednisone) within 2 weeks of first dose of IMNN-001 (if applicable) or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.
• Participant has mucinous, germ cell, transitional cell, clear cell, undifferentiated, or non-epithelial ovarian cancer.
• Participant has low-grade or Grade 1 epithelial ovarian cancer.
• Participant of childbearing potential, not practicing adequate contraception, participant who is pregnant, or participant who is breastfeeding are not eligible for this trial.
• Participant has a bowel obstruction by clinical symptoms or computed tomography (CT) scan, sub-occlusive mesenteric disease, abdominal or gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess.
• Participant has been diagnosed and/or treated with any therapy for invasive cancer \<3 years from study enrollment, completed adjuvant chemotherapy and/or targeted therapy at least 3 years from enrollment, or completed adjuvant hormonal therapy less than 4 weeks from enrollment.
• Participant with definitively treated non-invasive malignancies such as cervical carcinoma in situ, ductal carcinoma in situ, grade 1 or 2 Stage IA endometrioid endometrial cancer, or non-melanomatous skin cancer are allowed.
• Participant with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the participant to extreme risk or decreased life expectancy.
• Participant has known active hepatitis or HIV with detectable viral load.
• Participant has a known contraindication or uncontrolled hypersensitivity to the components of paclitaxel, carboplatin, IMNN-001, or their excipients.
• Prior treatment for high-grade non-mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (e.g., immunotherapy, anticancer therapy, surgery, radiation therapy).
• Participant is 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.
• Participant who has received prior radiotherapy to any portion of the abdominal cavity or pelvis is excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, if it was completed at least 3 years prior to registration, and the participant remains free of recurrent or metastatic disease.
• Participant who has received prior chemotherapy for any abdominal or pelvic tumor is excluded. Participant may have received prior adjuvant chemotherapy for localized breast cancer, if it was completed at least three years prior to registration, and that the participant remains free of recurrent or metastatic disease.

Sponsors & Collaborators

• Imunon: lead

Study Sites (7)

Advent Health

Orlando, Florida, 32804, United States

RECRUITING

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

Providence Cancer Institute

Portland, Oregon, 97213, United States

RECRUITING

Sanford Health

Sioux Falls, South Dakota, 57104, United States

RECRUITING

Erlanger Health

Chattanooga, Tennessee, 37403, United States

RECRUITING

Providence Sacred Heart Medical Center & Children's Hospital

Spokane, Washington, 99204, United States

RECRUITING

Froedtert and The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

GEN-1; Paclitaxel; Carboplatin; olaparib; niraparib

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Premal H Thaker, M.D.

  Washington University School of Medicine

  STUDY CHAIR

Central Study Contacts

Douglas Faller, M.D.

CONTACT

+1 609 896 9100; dfaller@imunon.com

Lauren Musso

CONTACT

+1 609 896 9100; lmusso@imunon.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 7, 2025
• Study Start: July 9, 2025
• Primary Completion (Estimated): October 31, 2032
• Study Completion (Estimated): October 31, 2032
• Last Updated: June 2, 2026

Record last verified: 2026-06

Locations

US (7)