Phase II Study of IMNN-001 with Chemotherapy and BEV for Newly Diagnosed Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Sponsor: Imunon

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05739981

Provider View

This clinical trial is testing the safety and effectiveness of adding a new drug, IMNN-001, to the standard chemotherapy and BEV treatment for patients with newly diagnosed advanced ovarian, fallopian tube, or primary peritoneal cancer.

Patient Parameters

Program Overview

The study aims to find out if adding IMNN-001 to the usual chemotherapy and BEV treatment can improve outcomes for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer. Participants will receive a combination of chemotherapy drugs (carboplatin and paclitaxel) and BEV, with some receiving the additional IMNN-001 treatment. The trial will assess the safety, proper dosing, and effectiveness of this new combination.

Description

This clinical trial is designed to evaluate whether adding a new drug, IMNN-001, to the standard chemotherapy and BEV treatment can improve outcomes for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer. The study involves a randomized, open-label, multi-center approach, meaning participants will be randomly assigned to receive either the standard treatment or the standard treatment plus IMNN-001, and both the researchers and participants will know which treatment is being given.

Participants will receive chemotherapy with carboplatin and paclitaxel every three weeks for 7-9 cycles. At least four cycles of chemotherapy will be given before surgery, with the possibility of two additional cycles based on the doctor's assessment. Surgery will occur 3-4 weeks after the last chemotherapy dose. After surgery and a recovery period of at least four weeks, participants will receive three more cycles of treatment. BEV will be included in cycles 2, 3, 6, and 7, and may be replaced by an FDA-approved biosimilar if needed. In the experimental group, IMNN-001 will be added weekly starting from the first cycle and continue through the last cycle of treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer.
  • Cancer is at stage III or IV and recommended for neoadjuvant therapy by a doctor.
  • Adequate bone marrow, kidney, liver, and nerve function.
  • No active infections requiring isolation or serious uncontrolled medical conditions.
  • Negative COVID-19 test or symptom-free for 14 days if previously positive.
  • Stopped any hormonal cancer treatment at least one week before starting the study.
  • Performance status score of 0-1, indicating good overall health.
  • Negative pregnancy test for women of childbearing potential and agreement to use effective contraception.
  • Signed informed consent form.
  • At least 18 years old.

Exclusion Criteria

  • Previous treatment with IMNN-001.
  • Allergic reactions to similar drugs.
  • Recent use of corticosteroids or need for ongoing immunosuppressive therapy.
  • Autoimmune diseases requiring treatment in the last two years.
  • HIV or HTLV infections.
  • Other invasive cancers within the last three years.
  • Prior radiation or chemotherapy for abdominal or pelvic tumors.
  • Active hepatitis or nephrotic syndrome.
  • Severe unrelated medical problems or significant heart disease.
  • Pregnant or breastfeeding women, or those not using contraception.
  • History of brain disease or recent stroke.
  • Recent diverticulitis or hemoptysis.
  • Conditions affecting the placement of the study drug catheter.

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