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Endometrial CancerPhase 2NCT05263492

Study of Lenvatinib w/ Pembro in Black Participants w/Mismatch Repair-Prof Recurrent Endometrial Cancer

A Phase 2 study testing Lenvatinib and Pembrolizumab in people with Endometrial Cancer and Mismatch Repair-Proficient, run by Virginia Commonwealth University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Determine the efficacy of the combination of lenvatinib and pembrolizumab in Black participants Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Lenvatinib and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
1 Apr 2022to 19 Oct 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically and/or cytologically confirmed endometrioid, serous, clear cell, carcinosarcoma, or de-differentiated or undifferentiated endometrial cancer with radiographic and/or clinical evidence of disease progression
  • Documented microsatellite stable disease as tested by either microsatellite instability polymerase chain reaction (MSI PCR) or deoxyribonucleic acid (DNA) mismatch repair (MMR) by immunohistochemistry (IHC)
  • Self-identify as being of predominantly (>50%) Black race, inclusive of Black, African-American, Black Hispanic (Afro-Latinx), African, or Afro-Caribbean ancestry
  • Received, ineligible for (by investigator determination), or declined platinum containing chemotherapy
  • Received no greater than two prior lines of therapy. Maintenance therapies and hormonal therapies will NOT count as a line of therapy.
  • Measurable disease as determined by RECIST v1.1:
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  • At least one lesion of ≥10 mm in the longest diameter for a non-lymph node, or ≥15 mm in the short-axis diameter for a lymph node that is serially measurable using computerized tomography/magnetic resonance imaging (CT/MRI)
  • Target lesions limited to a radiated field must show evidence of substantial size increase according to previous scans to be deemed a target lesion
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Ability to swallow oral medications
  • Patients who are not postmenopausal or have not undergone hysterectomy must have a documented negative serum pregnancy test within 72 hours prior to initiating study treatment
  • Note: Postmenopausal is defined as any of the following:
  • Age ≥ 60 years
  • Age < 60 years and amenorrheic for at least 1 year with follicle-stimulating hormone (FSH) and plasma estradiol levels in the postmenopausal range
  • Bilateral oophorectomy
  • Patients of child-bearing potential must agree to use a medically accepted method for preventing pregnancy during and for a minimum of 4 months following the last dose of lenvatinib or pembrolizumab
  • Patients with known brain metastases will be eligible if they have completed primary brain therapy (such as whole brain radiotherapy, stereotactic radiosurgery, or complete surgical resection) and if they have remained clinically stable, asymptomatic, and off of steroids for at least 28 days before starting study treatment
  • Toxicities from previous cancer therapies resolved to grade ≤1 unless specified otherwise (exceptions: chronic residual toxicities that in the opinion of the investigator are not clinically relevant, given the known safety/toxicity profiles of Lenvatinib and pembrolizumab, such as alopecia, grade ≤2 anemia; neuropathy related to previous chemotherapy must be resolved to grade ≤2)
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Carcinosarcoma (malignant mixed mullerian tumor), endometrial leiomyosarcoma, or endometrial stromal sarcoma
  • Unstable central nervous system (CNS) metastases
  • Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib
  • Pre-existing grade ≥3 gastrointestinal or non-gastrointestinal fistula
  • Radiographic evidence of major blood vessel invasion/infiltration
  • Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study treatment
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  • History of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction, cerebrovascular accident, stroke, or cardiac arrhythmia associated with hemodynamic instability within 12 months of the first dose of study treatment
  • Known history or evidence of interstitial lung disease or active, non-infectious pneumonitis
  • Administration of or condition requiring administration of systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to initiating study treatment Exception: Patients with conditions that can be managed with steroids equivalent to or less than an oral prednisone dose of 10 mg daily are not excluded from the study
  • Active autoimmune disease (with the exception of psoriasis) that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) or a documented history of clinically severe autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents Note: Patients with the conditions or medical history listed below are not excluded from the study.
  • Vitiligo
  • Resolved childhood asthma/atopy
  • Requirement for intermittent use of bronchodilators or local steroid injections or topical steroids
  • Hypothyroidism stable on hormone replacement
  • Sjogren's Syndrome
  • Has received >1 prior systemic chemotherapy regimen (other than adjuvant or neoadjuvant) for endometrial cancer; participants may receive up to two regimens of platinum-based chemotherapy in total, as long as one is given in the neoadjuvant or adjuvant treatment setting
  • Prior anticancer treatment within 28 days of study start
  • Prior treatment with any treatment targeting Vascular endothelial growth factor (VEGF)-directed angiogenesis, any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
  • Has received prior treatment with an agent directed to a stimulatory or co-inhibitory T-cell receptor other than an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, and who has discontinued from that treatment due to a grade 3 or higher immune-related adverse event (irAE)
  • Has received prior radiation therapy within 21 days of study start with the exception of palliative radiotherapy to bone lesions, which is allowed if completed 2 weeks of study start; participants must have recovered from all radiation-related toxicities and/or complications prior to randomization
  • Participants with urine protein ≥3.5 gram (g)/24 hour
  • Left ventricular ejection fraction (LVEF) below the institutional normal range as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO)
  • Prior immunotherapy (single or dual immune checkpoint inhibition, cellular or vaccine therapy)
  • Administration of a live vaccine within 30 days prior to initiating study treatment Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are permitted; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed. Coronavirus Disease 2019 (COVID-19) vaccines are allowed and encouraged
  • Administration of any investigational agent within 4 weeks prior to initiating study treatment
  • History of solid organ or allogeneic stem cell transplant
  • Known intolerance to either of the study drugs (or any of the excipients)
  • Known immunodeficiency, eg, human immunodeficiency virus (HIV) Note: HIV testing is not required for eligibility screening
  • Known active hepatitis B or C Note: hepatitis B and C testing is not required for eligibility screening
  • Serious (ie, grade ≥3) uncontrolled infection
  • Pregnancy or breastfeeding
  • Diagnosis or treatment for another malignancy within 2 years prior to study registration, with the following exceptions: complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, any in situ malignancy
  • Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

Other trials in United States

About this study

Official title: A Multicenter, Open-Label Phase 2 Study to Evaluate the Safety and Efficacy of Lenvatinib in Combination With Pembrolizumab in Black Participants With Mismatch Repair-Proficient Recurrent Endometrial Cancer

Determine the efficacy of the combination of lenvatinib and pembrolizumab in Black participants

Read the detailed description

This study is a single-arm, open-label, multicenter phase 2 trial designed to prospectively evaluate the safety and efficacy of lenvatinib in combination with pembrolizumab for mismatch repair proficient recurrent endometrial cancer in Black patients (a population under-represented on 2 FDA registration trials).

Keywords
Endometrial Cancer, Mismatch Repair-Proficient, Recurrent, Lenvatinib, Black Participants, Pembrolizumab
Medical subject headings
Endometrial Neoplasms, Recurrence

What participants receive

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

  • LenvatinibDrug

    Lenvatinib once a day by mouth every day

  • PembrolizumabDrug

    Pembrolizumab through a needle or tube in a vein (intravenously, IV) every 3 weeks.

Study groups in NCT05263492
Study groupRoleWhat they receive
Pembrolizumab & LenvatinibExperimentalLenvatinib, 20 mg administered orally (PO) once daily (QD) during each 21-day cycle, and Pembrolizumab, 200 mg administered by intravenous (IV) infusion on day 1 of each 21-day cycle.
Receives: Drug: Lenvatinib; Drug: Pembrolizumab

What is being measured

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

  1. Determine the Objective Response Rate (ORR) at 24 Weeks in Black Patients With Recurrent Endometrial Cancer Treated With Lenvatinib 20 mg Orally Daily in Combination With Pembrolizumab 200 mg IV Every 3 Weeks

    Number of patients evaluable for measurement of tumor response evaluated and recorded according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    Measured: 24 Weeks

Secondary outcomes (5)

  1. Determine the Median Progression Free Survival (PFS)

    Number of patients who are alive following last dose of study treatment

    Measured: Up to 90 days following the last dose of study treatment

  2. Determine the Median Progression Free Survival (PFS)

    Number of patients who have not had disease progression following last dose of study treatment

    Measured: Up to 90 days following the last dose of study treatment

  3. Determine the Median Progression Free Survival (PFS)

    Number of patients who have not relapsed following last dose of study treatment

    Measured: Up to 90 days following the last dose of study treatment

  4. Determine the Number of Patients With Treatment-related Adverse Events (AEs) in the Study Population

    Using criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0), all AEs captured

    Measured: Up to 30 days following the last dose of study treatment

  5. Determine the Number of Patients Who Discontinue Treatment Due to Treatment-related Adverse Events (AEs)

    Number of patients who discontinue treatment due to treatment-related AEs.

    Measured: up to 30 days (plus or minus 15 days) following last dose of study treatment, average of 4.75 months.

Timeline

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

  1. First posted2 Mar 2022
  2. Study start1 Apr 2022
  3. Primary completion13 Sep 2024
  4. Study completion19 Oct 2024

Why it stopped: Closed early due to low enrollment rates

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
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05263492
Sponsor's protocol ID
MCC-21-18659
Other IDs
HM20023447
Status last verified
Sep 2025
First submitted
21 Feb 2022
Last updated
2 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: There are no plans to share individual participant data to other researchers at this time.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenvatinib and Pembrolizumab in people with Endometrial Cancer and Mismatch Repair-Proficient, run by Virginia Commonwealth University 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 19 inclusion and 33 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: stopped early, as of the sponsor's last update on 2 Oct 2025. 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?

Yes. Results are posted in the registry (first posted 2 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the Objective Response Rate (ORR) at 24 Weeks in Black Patients With Recurrent Endometrial Cancer Treated With Lenvatinib 20 mg Orally Daily in Combination With Pembrolizumab 200 mg IV Every 3 Weeks (time frame: 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 NCT05263492.

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 2 Oct 2025.

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