RecruitingPhase 1Phase 2NCT05739981

Phase II IMNN-001 (Also Known as GEN-1) on SLL With BEV and NACT, Newly Diagnosed Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Phase II Study Evaluating the Effect of IMNN-001 on Second Look Laparoscopy (SLL) in Combination With Bevacizumab (BEV) and Neoadjuvant Chemotherapy (NACT) in Newly Diagnosed With Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Sponsor

Imunon

Enrollment

30 participants

Start Date

Feb 10, 2023

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer

Summary

This is a 1:1 randomized, open label, multi-center phase I/II trial to evaluate the safety, dosing, efficacy, and biological activity of adding IMNN-001 to chemotherapy + BEV compared to chemotherapy + BEV alone.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called IMNN-001 (also known as GEN-1, an immunotherapy delivered directly into the abdomen) plus bevacizumab (a targeted therapy) to standard chemotherapy can improve outcomes for women with newly diagnosed advanced ovarian, fallopian tube, or primary peritoneal cancer who are starting with chemotherapy before surgery. **You may be eligible if...** - You have been diagnosed with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer at stage III or IV - Your oncologist has recommended chemotherapy before surgery (neoadjuvant therapy) - Your general health is good (ECOG performance status 0–1) - Your bone marrow, kidney, liver, and nerve function are within acceptable levels - You have no active serious infections **You may NOT be eligible if...** - Your cancer is a different histological type - You have active autoimmune conditions or certain other serious medical problems - You are pregnant or of childbearing potential and unwilling to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPaclitaxel

Paclitaxel 175 mg/m2 IV

DRUGCarboplatin

Carboplatin AUC 5-6 IV

DRUGBevacizumab

BEV 15 mg/kg IV administration will be included with each cycle EXCEPT the following cycles: \[1\] Cycle 1, \[2\] the last cycle of neoadjuvant therapy immediately preceding ICS, and \[3\] the first cycle of adjuvant chemotherapy (i.e., first cycle after ICS). During the maintenance phase, BEV 15 mg/kg will be administered every 3 weeks as a single agent until disease progression or unacceptable toxicity for a maximum of an additional 18 cycles. In total, BEV may be administered up to 24 cycles. FDA approved BEV biosimilars may be used in this study in place of BEV.

DRUGIMNN-001

IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer