A Phase 2 Trial of Maintenance Abemaciclib/Letrozole After Systemic Therapy in Patients With Advanced or Recurrent Estrogen Receptor Positive, Mismatch Repair Proficient, TP53 Wildtype Endometrial Cancer
Dana-Farber Cancer Institute
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)
Description
This is a phase 2, single arm trial of maintenance letrozole/abemaciclib after carboplatin/paclitaxel chemotherapy with or without anti-PD-(L)1 blockade in patients with advanced or recurrent estrogen receptor (ER) positive (ER+), mismatch repair proficient (MMRP), tumor protein p53 (TP53) wild-type endometrial cancer. The U.S. Food and Drug Administration (FDA) has not approved abemaciclib or letrozole 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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have histologically confirmed either i) endometrioid endometrial cancer or ii) endometrial carcinosarcoma with endometrioid epithelial component. * Participants must have ER-positive disease, defined as ≥ 1 percent of tumor cell nuclei being immunoreactive by immunohistochemistry (IHC). If multiple analyses have been performed, judgment should be based on the most recent biopsy or pathology specimen analyzed in a CLIA (Clinical Laboratory Improvement Amendments)-certified laboratory. * Tumor must be TP53 wild-type as determined by immunohistochemistry (…
Interventions
- DrugAbemaciclib
CDK inhibitor, tablet taken orally per protocol.
- DrugLetrozole
Aromatase inhibitor, tablet taken orally per protocol.
- DrugPembrolizumab
Humanized immunoglobulin G4 monoclonal antibody, 4mL (milliliter) single-dose vial, via intravenous (into the vein) infusion per institutional standard of care.
Locations (6)
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Brigham and Women's HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Dana-Farber Cancer Institute at FoxboroughFoxborough, Massachusetts
- Dana-Farber Cancer Institute at MilfordMilford, Massachusetts
- Dana-Farber Cancer Institute at South Shore HospitalWeymouth, Massachusetts