Elacestrant + Everolimus for Endometrial Cancer

MP
KK
Overseen ByKim Kelly
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial tests how well elacestrant with everolimus works for the treatment of estrogen receptor (ER) positive endometrial cancer that has come back after a period of improvement (recurrent), that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Estrogen can cause the growth of cancer cells. Elacestrant lowers the amount of estrogen made by the body. This may help stop the growth of cancer cells that need estrogen to grow. Everolimus is in a class of medications called kinase inhibitors. It is also a type of angiogenesis inhibitor. Everolimus works by stopping cancer cells from reproducing and by decreasing blood supply to the cancer cells. Giving elacestrant with everolimus may be effective for treating patients with recurrent, advanced or metastatic ER positive endometrial cancer.

Who Is on the Research Team?

JS

Jordyn Silverstein, MD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with estrogen receptor (ER) positive endometrial (uterine) cancer that has come back, spread nearby, or to other parts of the body. Participants should have advanced or metastatic disease and be able to undergo study procedures.

Inclusion Criteria

I am 18 years old or older.
I have advanced or recurrent endometrial cancer with positive hormone receptors.
I have had at least one platinum chemotherapy; if dMMR, I have had immunotherapy too.
See 21 more

Exclusion Criteria

I have had allergic reactions or intolerance to elacestrant, everolimus, or similar drugs.
I do not have any serious uncontrolled illnesses or infections.
I have a digestive problem that affects how my body absorbs medicine.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive elacestrant and everolimus orally once daily on days 1-28 of each 28-day cycle

24 weeks
Regular visits for CT/PET/MRI scans and blood sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

1 year
Follow-up every 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Elacestrant
  • Everolimus

Trial Overview

The study is testing a combination of two drugs—elacestrant and everolimus—to see if they work together against ER-positive endometrial cancer that has returned or spread. Imaging scans and questionnaires are also part of the research.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treatment (elacestrant and everolimus)Experimental Treatment7 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials
373
Recruited
35,200+

Stemline Therapeutics, Inc.

Industry Sponsor

Trials
24
Recruited
6,500+