This phase II trial evaluates whether giving a glucagon-like peptide 1 receptor agonist (GLP-1RA) in combination with a levonorgestrel intrauterine device can help patients with obesity and early stage uterine cancer achieve clearance for hysterectomy or pursuit of pregnancy. Usually, patients with early-stage uterine cancer are treated with surgery to remove the uterus, otherwise known as a hysterectomy. For people who are too overweight to safely have this surgery, doctors will instead manage the cancer with a hormone secreting intrauterine device called a levonorgestrel intrauterine device. GLP-1RA are a class of medications that mimic the natural hormone glucagon-like peptide-1. These medications trigger the pancreas to release insulin, which can help lower blood sugar levels and delay gastric emptying. Semaglutide, tirzepatide, and liraglutide have become exceedingly popular for their effects on weight loss and obesity-related diseases. More recently, GLP-1RAs have exhibited risk reduction of various obesity associated cancers, including endometrial cancer. Adding GLP-1RAs to standard management with levonorgestrel intrauterine devices may improve the rate at which patients with early stage uterine cancer are able to proceed to hysterectomy or pursue pregnancy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07107334.
Locations matching your search criteria
United States
Florida
Gainesville
UF Health Cancer Institute - GainesvilleStatus: Active
Contact: Kaitlin Nicholson
Phone: 352-273-7660
PRIMARY OBJECTIVE:
I. To explore and generate preliminary evidence of potential clinical efficacy signals for treatment of endometrial intraepithelial neoplasia (EIN) or grade 1 endometrioid endometrial adenocarcinoma in obese patients who are not candidates for hysterectomy using a concurrent GLP-1RA and levonorgestrel-releasing intrauterine system (LNG-IUS) administration.
SECONDARY OBJECTIVE:
I. To evaluate tolerability, the impact on medical comorbidities, and perioperative outcomes with the addition of GLP-1RAs to LNG-IUS treatment in the target population.
EXPLORATORY OBJECTIVE:
I. To evaluate histological changes of the endometrium with concurrent levonorgestrel-releasing intrauterine device (LNG-IUD) and GLP-1RA treatment.
OUTLINE:
Patients receive semaglutide subcutaneously (SC) once weekly (QW) or tirzepatide SC QW or liraglutide SC once daily (QD). Treatment continues as clinically indicated, in the absence of disease progression or unacceptable toxicity, until patient achieves clearance for staging hysterectomy or pursuit of pregnancy, or up to 12 months if clearance or disease response/improvement is not achieved. Patients who have not already undergone LNG-IUD insertion prior to screening also undergo LNG-IUD insertion within 30 days of study registration. Patients also undergo magnetic resonance imaging (MRI) or transvaginal ultrasound during screening.
After completion of study treatment, patients are followed up at 30 days and then 6 and 12 months.
Lead OrganizationUF Health Cancer Institute - Gainesville
Principal InvestigatorKaitlin Nicholson