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Advanced Endometrial CarcinomaPhase 2NCT07634601

Elacestrant With Everolimus for the Treatment of Recurrent Advanced or Metastatic ER-Positive Endometrial Cancer

A Phase 2 study testing Biospecimen Collection, Computed Tomography and Elacestrant in people with Advanced Endometrial Carcinoma and Metastatic Endometrial Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Biospecimen Collection, Computed Tomography and Elacestrant
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
18 Dec 2026to 18 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • No prior history of other malignancies within past 2 years (besides endometrial cancer as per Inclusion #4). Individuals with the following cancers are eligible if diagnosed and treated within the past 2 years: ductal carcinoma in situ of the breast, cervical cancer in situ, melanoma in situ, and basal cell or squamous cell carcinoma of the skin, early stage breast cancer or cervical cancer, early stage renal cell carcinoma or any other likely curatively treated early stage malignancy. No concurrent malignancy or other serious medical condition as deemed by the investigator
  • 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)
  • Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and cycle 1 day 1. Radiation therapy that is given for palliative purposes, e.g. for pain control or prevention of a tumor associated complication is allowed during the study, with the exclusion of thoracic radiation. However, study medication should be held during the duration of the radiation therapy and the radiated tumor lesion cannot be used for assessment of treatment response. Radiation therapy should not be administered before the first response assessment
  • 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
  • Age < 60 with intact uterus AND amenorrhea for 12 consecutive months or more AND estrogen (estradiol) levels within postmenopausal range; OR
  • Status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation.
  • In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential
  • Women of child-bearing potential must use highly effective methods of contraception throughout the study and for 120 days after study drug discontinuation. Highly effective contraception methods include:
  • Total abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
  • Female sterilization (surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
  • Use of non-hormonal methods of contraception or placement of an nonhormonal intrauterine device (IUD) or intrauterine system (IUS)
  • Absolute neutrophil count ≥ 1.5 × 10^9/L (at screening)
  • Platelets ≥ 100 × 10^9/L (at screening)
  • Hemoglobin ≥ 8.0 g/dL (at screening)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3 x institutional upper limit of normal (ULN) (at screening)
  • Total serum bilirubin < 1.5 × ULN except for patients with Gilbert's syndrome who may be included if the total serum bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN (at screening)
  • Patients with type 2 diabetes are eligible if on stable therapy and hemoglobin A1c ≤ 8%
  • Patients fasting triglycerides must be ≤ 300 mg/dL
  • No evidence of clinically significant, active interstitial lung disease or pneumonitis on history or baseline imaging. Patients with pneumonitis related to radiation or prior therapies may be eligible at investigator discretion discretion if recovered at the time of study initiation
  • Patient can safely discontinue strong and moderate CYP3A4 inhibitors or inducers (e.g., certain azole antifungals, rifampin, some anticonvulsants) at least 14 days or 5 half lives whichever is shorter prior to first dose of study drug, or switch to acceptable alternatives

Who cannot join

  • 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
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  • 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
  • Women who are lactating
  • Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient's safety, inhibit protocol participation, or interfere with interpretation of trial results, and in the judgment of the investigator would make the patient inappropriate for entry into this trial
  • Patients must be able to follow concomitant medication restrictions:
  • Strong CYP3A4 inhibitor drugs, food and herbal products, including but not limited to: ceritinib, clarithromycin, cobicistat, danoprevir, dasabuvir, elvitegravir, idelalisib, itraconazole, ketoconazole, lopinavir, nefadozone, nelfinavir, ombitasvir, paritaprevir, posaconazole, ritonavir, saquinavir, telithromycin, tipranavir, troleandomycin, voriconazole
  • Moderate CYP3A4 inhibitor drugs, food and herbal products, including but not limited to: amprenavir, aprepitant, atazanavir, casopitant, cimetidine, ciprofloxacin, conivaptan, crizotinib, cyclosporine, darunavir, darunavir/ritonavir, diltiazem, dronedarone, erythromycin, faldaprevir, fluconazole, fluvoxamine, fosamprenavir, imatinib, isavuconazole, letermovir, netupitant, nilotinib, octreotide, tofisopam, verapamil
  • Strong CYP3A4 inducer drugs, food and herbal products, including but not limited to: carbamazepine, enzalutamide, lumacaftor, mitotane, phenobarbital, phenytoin, rifampin, rifabutin
  • Moderate CYP3A4 inducer drugs, food and herbal products, including but not limited to: bosentan, dabrafenib, efavirenz, etravirine, lesinurad, lopinavir, metamizole, modafinil, nafcillin, thioridazine, tipranavir/ritonavir, telotristat ethyl
  • Herbal preparations, including, but are not limited to, St. John's wort, kava, ephedra (ma huang), gingko biloba, DHEA, yohimbe, saw palmetto, and ginseng
  • Grapefruit, grapefruit juice, and grapefruit-containing beverages and other foods known to inhibit CYP3A4 and P-gp activity
  • Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period. Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, bacillus Calmette-Guérin (BCG), yellow fever, varicella and TY21a (Typhoid Vaccine Live Oral Ty21a) typhoid vaccines
  • Patients with rare hereditary disorders of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption are excluded, as everolimus contains lactose
  • Patients who require use of systemic corticosteroids is prohibited with the following exceptions:
  • Participants on a stable or decreasing dose of corticosteroids at baseline for management of brain metastasis.
  • Low dose systemic corticosteroids are needed to manage certain conditions (e.g., rheumatoid arthritis) if the dose is not expected to lead to moderate or strong CYP3A4 induction.
  • Single doses, topical applications (including mouthwashes), inhaled sprays, eye drops, and local injections are allowed.
  • Systemic short-term steroids are also allowed for treatment of adverse events (AEs)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michelle Poblete contact

310-741-9977

MichellePoblete@mednet.ucla.edu

Kim Kelly contact

310-206-8309

kmkelly@mednet.ucla.edu

United States1 site

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

    Michelle Poblete, 310-741-9977, MichellePoblete@mednet.ucla.edu

    Kim Kelly, 310-206-8309, kmkelly@mednet.ucla.edu

Other trials in United States

About this study

Official title: 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)

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To obtain an estimate of the proportion of patient's progression-free at 24 weeks (24-week PFS rate) with estrogen receptor positive (ER+) endometrial cancer following treatment with elacestrant and everolimus.

SECONDARY OBJECTIVE:

  1. To assess clinical benefit rate (CBR) where clinical benefit is defined as achieving a confirmed objective response (complete response [CR] or partial response [PR]) or achieving stable disease for a minimum duration of 4 months, objective response rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST version [v] 1.1), progression free survival (PFS) and safety following treatment with elacestrant and everolimus for patients with ER+ endometrial cancer.

OUTLINE:

Patients receive elacestrant orally (PO) once daily (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 computed tomography (CT) scan with or without positron emission tomography (PET) scan or magnetic resonance imaging (MRI) and blood sample collection throughout the study.

After completion of study treatment, patients are followed up every 12 weeks for 1 year.

Being tested
Biospecimen Collection, Computed Tomography, Elacestrant, Everolimus, Magnetic Resonance Imaging
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • ElacestrantDrug

    Also called (6R)-6-(2-(Ethyl((4-(2- (ethylamino)ethyl)phenyl)methyl)amino)-4-methoxyphenyl)- 5,6,7,8-tetrahydronaphthalen-2-ol, ER-306323, RAD 1901, RAD-1901

    Given PO

  • EverolimusDrug

    Also called 42-O-(2-Hydroxy)ethyl Rapamycin, Afinitor, Certican, RAD 001

    Given PO

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET scan

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT07634601
Study groupRoleWhat they receive
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.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Elacestrant; Drug: Everolimus; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 24 weeks

Secondary outcomes (4)

  1. Clinical benefit rate

    Clinical benefit is defined as achieving a confirmed objective response (complete response or partial response) or achieving stable disease for a minimum duration of 4 months, will be provided with the two-sided 95% confidence interval. Kaplan-Meier estimates and Kaplan Meier plots of this endpoint will be produced.

    Measured: Up to 1 year

  2. Objective response rate

    As per Response Evaluation Criteria in Solid Tumors version 1.1.

    Measured: Up to 1 year

  3. Progression free survival

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  4. Incidence of adverse events

    Measured: Up to 90 days after end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2026
  2. Study start18 Dec 2026 (estimated)
  3. Primary completion18 Dec 2028 (estimated)
  4. Study completion18 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07634601
Sponsor's protocol ID
26-0141
Other IDs
NCI-2026-03735
Status last verified
Jun 2026
First submitted
2 Jun 2026
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Computed Tomography and Elacestrant in people with Advanced Endometrial Carcinoma and Metastatic Endometrial Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michelle Poblete (310-741-9977, MichellePoblete@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients progression-free (time frame: At 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07634601.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.

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