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.
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
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
Single group
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT scan
Elacestrant
DrugGiven PO
Everolimus
DrugGiven PO
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Positron Emission Tomography
Procedure/SurgeryUndergo PET scan
Questionnaire Administration
Other interventionAncillary studies
Proportion of patients progression-free
Will be estimated using the Kaplan-Meier method, with the corresponding 95% confidence interval derived using Greenwood's formula.
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.
Objective response rate
As per Response Evaluation Criteria in Solid Tumors version 1.1.
Progression free survival
Incidence of adverse events
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Jonsson Comprehensive Cancer Center
Lead sponsor
Stemline Therapeutics, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
