Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standar… (NCT06915025) | Clinical Trial Compass
RecruitingPhase 3
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
United States500 participantsStarted 2025-07-09
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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.
✓. 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.
. 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.