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ALPINE: Maintenance Letrozole/Abemaciclib

NCT06366347 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-02-11

No results posted yet for this study

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)

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Panagiotis Konstantinopoulos, MD, PhD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-25
Primary Completion
2027-09-01
Completion
2029-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06366347 on ClinicalTrials.gov