protocolSection identificationModule nctId: NCT06366347, orgStudyIdInfo id: 23-695, briefTitle: ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2027-09-01, completionDateStruct date: 2029-03-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Dana-Farber Cancer Institute, class: OTHER, collaborators name: Eli Lilly and Company, descriptionModule briefSummary: A standard treatment for endometrial cancer is chemotherapy and pembrolizumab together followed by pembrolizumab maintenance for two years. This treatment regimen has shown benefit in terms of delaying cancer progression in prior clinical trials, but the benefit of the pembrolizumab maintenance treatment and whether all participants need it is unclear. This research is being done on the maintenance portion of treatment to compare the efficacy between the combination of letrozole + abemaciclib and pembrolizumab alone following chemotherapy and pembrolizumab.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)* Pembrolizumab (a type of monoclonal antibody), conditionsModule conditions: Endometrial Cancer, conditions: Recurrent Endometrial Cancer, conditions: TP53, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Abemaciclib, interventions name: Letrozole, interventions name: Pembrolizumab, outcomesModule primaryOutcomes measure: Median Progression Free Survival (PFS), secondaryOutcomes measure: Grade 3-5 Adverse Events (AE) Rate, secondaryOutcomes measure: Median Overall Survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beth Israel Deaconess Medical Center, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Meghan Shea, MD, role: CONTACT, phone: 617-667-3723, email: mshea4@bidmc.harvard.edu, contacts name: Meghan Shea, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Panagiotis Konstantinopoulos, MD, PhD, role: CONTACT, phone: 617-632-2334, email: Panagiotis_Konstantinopoulos@dfci.harvard.edu, contacts name: Panagiotis Konstantinopoulos, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Dana-Farber Cancer Institute, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Panagiotis Konstantinopoulos, MD, PhD, role: CONTACT, phone: 617-632-2334, email: Panagiotis_Konstantinopoulos@dfci.harvard.edu, contacts name: Panagiotis Konstantinopoulos, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Dana-Farber Cancer Institute at Foxborough, city: Foxboro, state: Massachusetts, zip: 02035, country: United States, contacts name: Natalie Sinclair, MD, role: CONTACT, phone: 508-543-1700, email: natalie_sinclair@dfci.harvard.edu, contacts name: Natalie Sinclair, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.06538, lon: -71.24783, locations facility: Dana-Farber Cancer Institute at Milford, city: Milford, state: Massachusetts, zip: 01757, country: United States, contacts name: Alexandra Bailey, MD, role: CONTACT, phone: 508-488-3700, email: alexandras_bailey@dfci.harvard.edu, contacts name: Alexandra Bailey, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.13982, lon: -71.51617, locations facility: Dana-Farber Cancer Institute at South Shore Hospital, city: Weymouth, state: Massachusetts, zip: 02190, country: United States, contacts name: Meredith Faggen, MD, role: CONTACT, phone: 781-624-4800, email: meredith_faggen@dfci.harvard.edu, contacts name: Meredith Faggen, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.22093, lon: -70.93977, hasResults: False