Full Title
A Phase II Study Evaluating the effect of GEN-1 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) on Second Look Laparoscopy (SLL) when Administered in Combination with Bevacizumab (BEV) and Neoadjuvant Chemotherapy (NACT) in Subjects Newly Diagnosed with Advanced Ovarian, Fallopian Tube or Primary Peritoneal CancerPurpose
Researchers want to see if adding IMNN-001 to standard treatment works well against advanced gynecologic cancers. The people in this study have newly diagnosed ovarian, fallopian tube, or primary peritoneal cancers.
One of the standard treatment approaches for these cancers is bevacizumab and chemotherapy before and after cancer surgery. Adding IMNN-001 may boost your immune system and help your body kill cancer cells.
If you join this study, you will be randomly assigned to get one of these treatments before surgery:
- IMNN-001, bevacizumab, and chemotherapy (carboplatin and paclitaxel). IMNN-001 is given directly into the abdomen. Bevacizumab and chemotherapy are given intravenously (by vein).
- Bevacizumab and chemotherapy alone.
You will then have surgery to remove the cancer. After you recover, you will get more of the treatment you received before surgery. Then you will have second-look laparoscopy surgery to check for minimal residual disease (MRD). MRD is a small amount of cancer cells remaining in the body after treatment.
The researchers will compare the effects of the two treatment regimens on MRD. After second-look surgery, you will continue to get anti-cancer medications for up to two years.
Who Can Join
To join this study, there are a few conditions. You must:
- Have newly diagnosed advanced ovarian, fallopian tube, or primary peritoneal cancer that has not yet been treated.
- Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
- Be age 18 or older.
Contact
For more information or to see if you can join this study, please call Dr. Chrisann Kyi’s office at 646-888-4221.