Actively Recruiting
A Study of Elacestrant Alone or in Combination With Abemaciclib in People With Endometrial Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-18
75
Participants Needed
7
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The researchers are doing this study to find out whether elacestrant is an effective and safe treatment alone or in combination with abemaciclib for people with advanced or recurrent ER+ endometrial cancer.
CONDITIONS
Official Title
A Study of Elacestrant Alone or in Combination With Abemaciclib in People With Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Prior treatment with platinum-based chemotherapy and PD-1 inhibitor, alone or combined
- No more than 1 prior chemotherapy line for endometrial carcinoma
- No more than 1 prior endocrine therapy line for endometrial carcinoma
- No prior treatment with CDK4/6 inhibitors
- Measurable disease per RECIST v1.1 criteria
- Advanced or recurrent endometrial carcinoma refractory to curative therapy
- Eligible histologic epithelial cell types including endometrioid and serous adenocarcinoma among others
- ER-positive tumor status with ≥1% staining by immunohistochemistry
- p53 wild type status by IHC or sequencing
- No known dMMR or POLE mutation
- Tissue available for MSK IMPACT molecular profiling if not already done
- Female patients may be premenopausal, perimenopausal, or postmenopausal with specified criteria
- Use of contraception for participants of child-bearing potential during and after study
- Discontinued prior radiotherapy with full recovery and required washout periods
- Adequate hematologic, renal, hepatic, and coagulation laboratory values
You will not qualify if you...
- Participation in other experimental treatments within 30 days or 5 half-lives prior to randomization
- Experiencing visceral crisis, lymphangitic disease spread, or leptomeningeal carcinomatosis
- Prior treatment with elacestrant, investigational oral SERDs, mTOR inhibitors, or CDK4/6 inhibitors
- Uncontrolled hyperlipidemia
- History or evidence of interstitial lung disease or pneumonitis
- Uncontrolled active infections (with some exceptions for treated HIV, HBV, HCV)
- Pregnant or nursing females; positive pregnancy test at screening for childbearing potential
- Prior or concurrent malignancies interfering with study safety or efficacy
- Major surgery within 4 weeks prior to randomization
- Inability to take oral medication or uncontrolled gastrointestinal conditions
- Known intolerance to study drugs or excipients
- Severe medical or psychiatric conditions preventing study participation
- Uncontrolled low magnesium or potassium levels despite supplementation
- Untreated or active central nervous system metastases with specific exceptions
- Inability to comply with study and follow-up procedures
- Recent use of CYP3A4 inducers or inhibitors, herbal supplements within specified timeframes
- Any other condition or abnormality that may contraindicate investigational drug use or affect results
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
S
Sminu Bose, MD
CONTACT
V
Vicky Makker, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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