MULTICENTER TRIAL OF SELINEXOR IN MAINTENANCE THERAPY
AFTER SYSTEMIC THERAPY FOR PATIENTS WITH P53WILD-TYPE,
ADVANCED OR RECURRENT ENDOMETRIAL CARCINOMA
The University of Virginia is conducting a clinical research study for adults ages 18 and over who have been diagnosed with TP53 wild-type endometrial carcinoma and had a response to prior systemic chemotherapy. The purpose of this study is to evaluate the safety and effectiveness of selinexor for maintenance in patients with TP53 wild-type endometrial cancer. Selinexor is a medicine that is FDA approved for Multiple Myeloma and Diffuse large B-cell lymphoma but is not yet approved for endometrial cancer (EC). This means the study drug is considered investigational for use with EC. Selinexor is a selective inhibitor of nuclear export compound that binds and inactivates exportin 1 (XPO1) and promotes apoptosis in malignant cells. This is a randomized study, so patients will be assigned to receive either selinexor or placebo. The choice of treatment (selinexor or placebo) will be determined by a computer system. During randomization you will have a 50% chance to be assigned to the experimental arm (selinexor) and 50% chance to be assigned to the placebo arm. This is also a blinded study meaning that neither you nor your doctor will know if you are receiving selinexor or placebo. The treatment period consists of blocks of time called cycles, which last 28 days. You will take a fixed dose of 60 mg of the study drug, selinexor, or placebo once weekly.
Participation includes a pre-screening visit, screening visit, treatment visit per cycle (including CT imaging), end-of-treatment, safety follow-up visit, and a follow-up period to keep track of how you are doing. The length of time that you receive study treatment will depend on how well you tolerate the treatment and the effect it has on your cancer. Selinexor or placebo will be given orally via a tablet.
Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.
Additional information can be found here: https://clinicaltrials.gov/study/NCT05611931?term=NCT05611931
Reimbursement: You may be reimbursed up to $60 per visit for travel. With prior approval from the sponsor, your lodging may also be reimbursed.