ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab

Status Not yet recruiting

Clinical Trial 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)

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06366347
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact	Panagiotis Konstantinopoulos, MD, PhD
Phone	617-632-2334
Email	Panagiotis_Konstantinopoulos@DFCI.HARVARD.EDU
Status	Not yet recruiting
Phase	Phase 2
Start date	September 2024
Completion date	March 1, 2029

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05796518` - Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors	N/A
Recruiting	`NCT05489211` - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)	Phase 2
Active, not recruiting	`NCT03667716` - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.	Phase 1
Active, not recruiting	`NCT03170960` - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors	Phase 1/Phase 2
Not yet recruiting	`NCT06463028` - Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, Serabelisib With Paclitaxel, and Paclitaxel Alone in Patients With Advanced/Recurrent Endometrial Cancer	Phase 2
Recruiting	`NCT06036836` - Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)	Phase 2
Terminated	`NCT04586335` - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.	Phase 1
Completed	`NCT03820024` - MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback	N/A
Active, not recruiting	`NCT05082025` - Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations	Phase 2
Active, not recruiting	`NCT00587886` - Estrogen, Diet, Genetics and Endometrial Cancer
Completed	`NCT05378152` - Assessing the Benefit of Pipelle Biopsy in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity	N/A
Suspended	`NCT05124743` - HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
Recruiting	`NCT03876860` - An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis	N/A
Recruiting	`NCT04569773` - Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer
Completed	`NCT04534309` - Behavioral Weight Loss Program for Cancer Survivors in Maryland	N/A
Not yet recruiting	`NCT06073184` - Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium	Phase 2
Not yet recruiting	`NCT05998798` - Revealing Engagement Patterns Among Endometrial Cancer Patients
Terminated	`NCT02907073` - Positron Emission Tomography (PET) Imaging Studies With NIS Reporter	Phase 1/Phase 2
Completed	`NCT02413606` - ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More?	N/A
Completed	`NCT02549989` - Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer	Phase 2