Spots Global Cancer Trial Database for ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab

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Trial Identification

Brief Title: ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab

Official Title: Phase 2, Randomized, Trial of Maintenance Letrozole/Abemaciclib vs Pembrolizumab After Systemic Therapy in Patients With Advanced or Recurrent Estrogen Receptor Positive, Mismatch Repair Proficient, TP53 Wild-type Endometrial Cancer

Study ID: NCT06366347

Conditions

Endometrial Cancer

Recurrent Endometrial Cancer

TP53

Interventions

Abemaciclib

Letrozole

Pembrolizumab

Study Description

Brief Summary: 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)

Detailed Description: This is a randomized, phase 2 trial of maintenance letrozole + abemaciclib vs. pembrolizumab after carboplatin + paclitaxel + pembrolizumab chemotherapy in participants with advanced or recurrent estrogen receptor (ER) positive (ER+), mismatch repair proficient (MMRP), TP53 wild-type endometrial cancer. Participants will be randomized in one of two study groups: Abemaciclib + Letrozole vs. Pembrolizumab. Randomization means that a participant is placed into a study group by chance. The U.S. Food and Drug Administration (FDA) has not approved abemaciclib, letrozole or pembrolizumab 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 76 people will take part in this research study. Eli Lilly is supporting this research study by providing funding and the study drug abemaciclib.