NCT06366347

ALPINE: Maintenance Letrozole/Abemaciclib

A Phase 2 Trial of Maintenance Abemaciclib/Letrozole After Systemic Therapy in Patients With Advanced or Recurrent Estrogen Receptor Positive, Mismatch Repair Proficient, TP53 Wildtype Endometrial Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to see if the study drugs abemaciclib and letrozole are effective and safe for participants with estrogen-receptor positive (ER+), mismatch repair proficient, tumor protein p53 (TP53) wild-type endometrial cancer. The names of the study drugs involved in this study are: * Abemaciclib (a type of cyclin-dependent kinase (CDK) inhibitor) * Letrozole (a type of aromatase inhibitor)

Detailed description

This is a phase 2, single arm trial of maintenance letrozole/abemaciclib after carboplatin/paclitaxel chemotherapy with or without anti-PD-(L)1 blockade in patients with advanced or recurrent estrogen receptor (ER) positive (ER+), mismatch repair proficient (MMRP), tumor protein p53 (TP53) wild-type endometrial cancer. The U.S. Food and Drug Administration (FDA) has not approved abemaciclib or letrozole for endometrial cancer but they have been approved for other uses. The research study procedures include screening for eligibility, study treatment visits, X-rays, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, Positron Emission Tomography (PET) scans, blood tests, and electrocardiograms (EKGs). Participants will be administered study drugs for up to 2 years and will be followed for 3 years after completing study treatment. It is expected that about 32 people will take part in this research study. Eli Lilly is supporting this research study by providing funding and the study drug abemaciclib.

Conditions

• Endometrial Cancer
• Recurrent Endometrial Cancer
• TP53

Interventions

Type	Name	Description
DRUG	Abemaciclib	CDK inhibitor, tablet taken orally per protocol.
DRUG	Letrozole	Aromatase inhibitor, tablet taken orally per protocol.
DRUG	Pembrolizumab	Humanized immunoglobulin G4 monoclonal antibody, 4mL (milliliter) single-dose vial, via intravenous (into the vein) infusion per institutional standard of care.

Timeline

• Start date: 2024-09-25
• Primary completion: 2027-09-01
• Completion: 2029-03-01
• First posted: 2024-04-15
• Last updated: 2026-02-11

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study