Phase 3 Study on the Safety and Effectiveness of IMNN-001 with Chemotherapy for Newly Diagnosed Advanced Ovarian, Fallopian Tube, or Peritoneal Cancer
Sponsor: Imunon
ClinicalTrials ID:NCT06915025
This clinical trial is testing a new treatment, IMNN-001, combined with standard chemotherapy, to see if it is safe and effective for women with advanced ovarian, fallopian tube, or peritoneal cancer. The study compares this combination to chemotherapy alone.
Patient Parameters
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Program Overview
The study aims to evaluate the safety and effectiveness of a new treatment, IMNN-001, given with chemotherapy for women with advanced ovarian, fallopian tube, or peritoneal cancer. Participants will be randomly assigned to receive either the combination of IMNN-001 and chemotherapy or chemotherapy alone. The treatment involves cycles of chemotherapy drugs paclitaxel and carboplatin, with IMNN-001 given on specific days. The study will monitor participants' safety and the treatment's impact on cancer.
Description
Participants in this study will be randomly divided into two groups. One group will receive chemotherapy along with the new treatment, IMNN-001, while the other group will receive only chemotherapy. The chemotherapy involves drugs called paclitaxel and carboplatin, given in cycles every three weeks. IMNN-001 will be given on certain days during these cycles. After three cycles, participants will have surgery to remove as much of the cancer as possible, followed by three more cycles of treatment. An independent committee will oversee the study to ensure participants' safety.
Eligibility Criteria
Inclusion Criteria
- Women aged 18 or older who understand the study and agree to participate.
- Diagnosed with advanced high-grade ovarian, fallopian tube, or peritoneal cancer.
- Eligible to receive chemotherapy before surgery.
- Willing to provide a tumor sample for testing.
- Women who can become pregnant must have a negative pregnancy test and use effective birth control.
- Must have adequate blood, kidney, liver, and nerve function.
- Must be in good overall health with an ECOG score of 0, 1, or 2.
- Free of serious infections or medical conditions within four weeks of starting the study.
- Must stop any hormonal cancer treatments at least one week before starting the study.
Exclusion Criteria
- Previous treatment with IMNN-001.
- Recent use of high-dose steroids or need for ongoing immunosuppressive therapy.
- Certain types of ovarian cancer, such as mucinous or germ cell cancer.
- Low-grade ovarian cancer.
- Pregnant or breastfeeding women, or those not using effective birth control.
- Bowel obstruction or certain abdominal conditions.
- Recent treatment for other invasive cancers.
- Severe medical conditions unrelated to cancer.
- Active hepatitis or HIV with detectable viral load.
- Allergies to study drugs.
- Previous treatment for the specific type of cancer being studied.
- Active autoimmune diseases requiring treatment.
- Previous radiation to the abdomen or pelvis.
- History of brain disease or recent stroke.
- Use of bevacizumab with treatment.
- Conditions affecting the placement of the study drug catheter.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Washington University School of Medicine in St. Louis | 63110 | St Louis | Missouri |
| Providence Cancer Institute | 97213 | Portland | Oregon |
| Erlanger Health | 37403 | Chattanooga | Tennessee |
| Providence Sacred Heart Medical Center & Children's Hospital | 99204 | Spokane | Washington |
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