Elacestrant With Everolimus for the Treatment of Recurrent Advanced or Metastatic ER-Positive Endometrial Cancer
A Phase II Study of Elacestrant, an Oral Selective Estrogen Receptor Degrader (SERD) Combined With Everolimus in Patients With Recurrent or Metastatic ER-Positive (ER+) Endometrial Cancer (ELAVERA)
2 other identifiers
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2026
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2026
CompletedFirst Posted
Study publicly available on registry
June 9, 2026
CompletedStudy Start
First participant enrolled
December 18, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2028
Study Completion
Last participant's last visit for all outcomes
December 18, 2029
June 9, 2026
June 1, 2026
2 years
June 2, 2026
June 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients progression-free
Will be estimated using the Kaplan-Meier method, with the corresponding 95% confidence interval derived using Greenwood's formula.
At 24 weeks
Secondary Outcomes (4)
Clinical benefit rate
Up to 1 year
Objective response rate
Up to 1 year
Progression free survival
At the end of Cycle 1 (each cycle is 28 days)
Incidence of adverse events
Up to 90 days after end of treatment
Study Arms (1)
Treatment (elacestrant and everolimus)
EXPERIMENTALPatients receive elacestrant PO QD and everolimus PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan with or without PET scan or MRI and blood sample collection throughout the study.
Interventions
Undergo blood sample collection
Undergo CT scan
Given PO
Given PO
Undergo MRI
Undergo PET scan
Eligibility Criteria
You may qualify if:
- Must be ≥ 18 years of age
- Ability to understand and the willingness to sign a written informed consent document. Patient must sign the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Participants must have histologically confirmed advanced (International Federation of Gynecology and Obstetrics \[FIGO\] stage III or IV), persistent, or recurrent endometrial cancer (histologic documentation of recurrence not required) that has
- Patient's archival endometrial cancer tumor specimen has positive hormone receptor expression defined as "positive" or ≥ 1% by immunohistochemistry (IHC) performed at any Clinical Laboratory Improvement Act (CLIA)-certified laboratory
- Can be any histologic subtype including endometrioid, mixed, serous, clear cell, carcinosarcoma
- Prior treatment with at least one line of platinum-based chemotherapy is required (can be in the adjuvant setting):
- Patients with mismatch repair deficiency (dMMR) tumors must have received at least one prior line of immunotherapy. An exception may be made for patients with documented contraindications to immunotherapy, including but not limited to severe autoimmune conditions, solid organ transplantation, or lack of access to immunotherapy.
- Prior exposure to to progestins, aromatase inhibitors, tamoxifen, selective estrogen receptor down regulator (SERD) is allowed if the last dose was ≥ 4 weeks before enrollment Availability of adequate archival tumor tissue (from initial biopsy, surgical specimen, or repeat biopsy) is preferred but not required for study entry. When available, archival tissue should consist of either one unstained slide cut at 4-5 µm or one formalin-fixed paraffin-embedded (FFPE) tissue block with one corresponding H\&E slide, submitted per the Lab Manual. If archival tissue is not available, the participant may still be enrolled with Principal Investigator approval prior to study entry
- Patients who received chemotherapy or hormonal therapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] grade ≤ 1) from the acute effects of chemotherapy except for residual alopecia or grade 2 peripheral neuropathy prior to enrollment. A washout period of at least 21 days is required between last chemotherapy dose and enrollment (provided the patient did not receive radiotherapy)
- Able to take study medication by mouth
- Pre- and postmenopausal women are eligible. Premenopausal women of childbearing potential must have a negative serum pregnancy test at time of screening. Woman of childbearing potential (WOCBP) is defined as follows:
- Any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or a bilateral oophorectomy) OR
- Any female who is not postmenopausal defined as:
- Age ≥ 60 years; OR
- +16 more criteria
You may not qualify if:
- Patients who have previously received everolimus or any another mTOR (mammilian target of rapamycin) inhibitor (eg. sirolimus, temsirolimus) for the treatment of endometrial cancer and are no longer receiving therapy with washout
- Participants who are receiving any other anti-cancer approved or investigational agents within \< 21 days or 4 weeks if fulvestrant prior to cycle 1 day 1. Participation in other observational studies is permitted
- Symptomatic brain metastases or carcinomatous meningitis. Patients with treated brain metastases may be eligible if they are asymptomatic and neurologically stable, and demonstrate radiographic stability at screening, confirmed at least 28 days following completion of definitive treatment (e.g., surgery and/or radiation therapy)
- History of other malignancies within past 2 years, except ductal carcinoma in situ of the breast, cervical cancer in situ, melanoma in situ, basal cell or squamous cell carcinoma of the skin or early stage cancers deemed curable by investigator. No concurrent malignancy or other serious medical condition as deemed by the investigator
- Herbal preparations/medications are prohibited throughout the study. These herbal medications include, but are not limited to: St. John's wort, Kava, ephedra (ma huang), gingko biloba, black cohosh, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng. Patients should stop using these herbal medications 7 days prior to first dose of study drug
- Patients receiving chronic treatment with systemic steroids (\> 10mg prednisone equivalent) or another immunosuppressive agent
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment (e.g. estimated creatinine clearance \< 30ml/min), symptomatic angina pectoris, cardiac arrhythmia, a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea) are ineligible
- Patient with active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\])
- Screening for HIV and hepatitis is not required for enrollment
- The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
- Any of the following within 6 months prior to trial registration: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism
- History of hypersensitivity or intolerance to elacestrant, everolimus, other rapamycin analogs (eg. temsirolimus, sirolimus) or any of the components in either medication
- Pregnant women are excluded from this study because embryo-fetal toxicity is a potential side effect of elacestrant and everolimus. For this reason, women of child-bearing potential (WOCBP) must agree to use highly effective contraception prior to study entry, for the duration of treatment, and for at least 120 days after the completion of treatment. Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy
- Women of child-bearing potential, who will not use a highly effective method of contraception
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jonsson Comprehensive Cancer Centerlead
- Stemline Therapeutics, Inc.collaborator
Study Sites (1)
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jordyn Silverstein, MD
UCLA / Jonsson Comprehensive Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2026
First Posted
June 9, 2026
Study Start (Estimated)
December 18, 2026
Primary Completion (Estimated)
December 18, 2028
Study Completion (Estimated)
December 18, 2029
Last Updated
June 9, 2026
Record last verified: 2026-06