Phase 2 Study of Maintenance Abemaciclib and Letrozole After Chemotherapy for Advanced or Recurrent Estrogen Receptor Positive Endometrial Cancer with Normal TP53 and Mismatch Repair

What this Trial Is About

Researchers are evaluating if the study drugs abemaciclib and letrozole are effective and safe for people with advanced or recurrent estrogen receptor-positive ER endometrial cancer that is mismatch repair proficient and has tumor protein p53 TP53 wild-type. This phase 2, single arm trial focuses on maintenance treatment following chemotherapy with or without anti-PD-L1 blockade. The FDA has not approved these drugs for endometrial cancer but has approved them for other uses. Participants will receive abemaciclib tablets twice daily and letrozole tablets once daily in 21-day cycles. Treatment will continue for up to 2 years. Scans such as X-rays, CT, MRI, or PET will be done every 9 weeks for the first 9 months, then annually. After treatment ends, participants will have assessments and continue follow-up for up to 3 years. The study is supported by Eli Lilly, which provides funding and the abemaciclib drug. During the study, participants will undergo screening and regular evaluations including scans, blood tests, and electrocardiograms EKGs. Researchers will monitor progression-free survival over 2 years as the primary outcome. Secondary outcomes include adverse event rates, overall survival up to 5 years, and objective response rate. Participants must have good performance status and normal organ function to join and will be followed closely throughout treatment and follow-up periods.

ALPINE: Maintenance Letrozole/Abemaciclib