Actively Recruiting
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
Led by Imunon · Updated on 2026-05-04
500
Participants Needed
7
Research Sites
381 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older who understand and agree to study procedures with written consent
- Histologically confirmed high-grade non-mucinous epithelial ovarian, fallopian tube, or peritoneal cancer at Stage IIIB, IIIC, or IV
- Eligible to receive neoadjuvant chemotherapy
- Provision of tumor tissue sample for biomarker tumor status confirmation
- Negative serum pregnancy test within 14 days before starting treatment and use of effective contraception for those of childbearing potential
- Adequate bone marrow, renal, hepatic, and neurologic function as specified
- ECOG performance status score of 0, 1, or 2
- Free from active infection requiring intravenous antibiotics or serious uncontrolled medical illness within 4 weeks before study entry
- Discontinued any hormonal therapy targeting the malignant tumor at least 1 week before first treatment except hormone replacement therapy
You will not qualify if you...
- Previous treatment with IMNN-001
- Use of corticosteroids over 10 mg prednisone within 2 weeks before first IMNN-001 dose or need for ongoing systemic immunosuppressive therapy not related to chemotherapy
- Diagnosis of mucinous, germ cell, transitional cell, clear cell, undifferentiated, or non-epithelial ovarian cancer
- Low-grade or Grade 1 epithelial ovarian cancer
- Pregnancy, breastfeeding, or inadequate contraception in those of childbearing potential
- Bowel obstruction, sub-occlusive mesenteric disease, fistula, perforation, or intra-abdominal abscess
- Diagnosis or treatment of invasive cancer within 3 years prior to enrollment, with some exceptions for certain non-invasive cancers
- Severe medical problems unrelated to cancer limiting study compliance or life expectancy
- Active hepatitis or HIV infection with detectable viral load
- Known allergy or intolerance to paclitaxel, carboplatin, IMNN-001, or their components
- Prior treatment for high-grade non-mucinous epithelial ovarian, fallopian tube, or peritoneal cancer
- Active autoimmune disease requiring therapy
- Prior abdominal or pelvic radiotherapy, with some exceptions
- Prior chemotherapy for abdominal or pelvic tumors, with exceptions
- History or evidence of central nervous system disease or recent stroke
- Planned use of bevacizumab with neoadjuvant, adjuvant, or maintenance therapy
- Conditions preventing proper placement of the intraperitoneal catheter, including recent abdominal surgery or intestinal dysfunction
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Advent Health
Orlando, Florida, United States, 32804
Actively Recruiting
2
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
3
Providence Cancer Institute
Portland, Oregon, United States, 97213
Actively Recruiting
4
Sanford Health
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
5
Erlanger Health
Chattanooga, Tennessee, United States, 37403
Actively Recruiting
6
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, United States, 99204
Actively Recruiting
7
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
D
Douglas Faller, M.D.
CONTACT
L
Lauren Musso
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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