Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366347
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-08
Brief Title:
ALPINE Maintenance LetrozoleAbemaciclib vs Pembrolizumab
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase 2 Randomized Trial of Maintenance LetrozoleAbemaciclib vs Pembrolizumab After Systemic Therapy in Patients With Advanced or Recurrent Estrogen Receptor Positive Mismatch Repair Proficient TP53 Wild-type Endometrial Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 US 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
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 US 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None