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Recruiting NCT06915025

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

Conditions: Epithelial Ovarian Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 500
Sponsor: Imunon

Location: Advent Health Orlando Florida

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.

Eligibility Criteria

Inclusion Criteria: 1. 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 prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, participants must discontinue breastfeeding prior to study entry. 6. Participants must have adequate: 1. 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. 2. Renal function: eGFR \> 60 ml/min/1.73m2 3. 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. 4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1 as defined by CTCAE version 5.0. 7. Participants must have an ECOG score of 0, 1 or 2. 8. Participants should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within 4 weeks of study entry. 9. 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. Exclusion Criteria: 1. Participant who has received prior treatment with IMNN-001. 2. 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. 3. Participant has mucinous, germ cell, transitional cell, clear cell, undifferentiated, or non-epithelial ovarian cancer. 4. Participant has low-grade or Grade 1 epithelial ovarian cancer. 5. Participant of childbearing potential, not practicing adequate contraception, participant who is pregnant, or participant who is breastfeeding are not eligible for this trial. 6. 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. 7. Participant has been diagnosed and/or treated with any therapy for invasive cancer \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06915025). StuddyBuddy aggregates publicly available trial information.