New combo shows promise for Tough-to-Treat uterine cancer

NCT ID NCT07594015

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 4 times

Summary

This study tests two drugs, pembrolizumab and lenvatinib, in people with a type of uterine cancer that has come back after initial treatment. The cancer must be mismatch repair proficient, meaning it has a specific genetic feature. The goal is to see if this drug combination can shrink or stabilize the tumor. About 46 adults will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 46 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Aug 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically confirmed recurrent endometrial carcinoma, including serous, endometrioid, carcinosarcoma, clear cell subtypes, with measurable disease per RECIST 1.1 criteria. 2. Mismatch repair (MMR) proficient status confirmed by IHC (Immunohistochemistry) or molecular testing. 3. Patients must have failed first-line therapy with platinum based doublet with prior immunotherapy. 4. Patient must have completed next-generation sequencing on either primary or recurrent tumor. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3. 6. Age ≥ 18 years. 7. Female participants must be of non-childbearing potential or for females of child bearing potential (FOCBPs), must agree to use contraception as described in Section 5.6. FOCBPs must not be pregnant or breastfeeding. 8. At least one measurable lesion according to RECIST 1.1. 9. Adequate organ function, including: * Hemoglobin ≥ 8 g/dL (blood transfusions are permitted) * Absolute neutrophil count ≥ 1000 * Platelet count ≥ 100 x 10⁹/L * Glomerular filtration rate (GFR) ≥ 30 mL/min * Bilirubin ≤ 1.5 x ULN (upper limit of normal) 10. Written informed consent obtained from the patient. 11. At least 3 weeks must have elapsed from any prior therapy Exclusion Criteria: 1. Uterine sarcoma 2. Active central nervous system metastases or leptomeningeal disease. 3. History of severe allergic reactions to pembrolizumab, lenvatinib, or any components of the formulations. 4. Active autoimmune disease requiring chronic systemic steroids for \> 3 months in the last 6 months prior to enrollment. 5. Pregnancy or breastfeeding at the time of enrollment. 6. Previous treatment with lenvatinib or other VEGFR inhibitors. 7. Concurrent treatment with other investigational drugs or anti-cancer therapies except for adjuvant hormonal therapy for breast cancer. 8. Uncontrolled concurrent illness, such as active infections that could interfere with study participation. 9. Blood pressure \>160 systolic or \>110 diastolic averaged over last 3 documented measurements. 10. History of significant cardiovascular events within 12 months prior to enrollment, including myocardial infarction, unstable angina, or congestive heart failure (NYHA Class III or IV). 11. History of organ transplant or immune suppressive therapy that would interfere with the efficacy or safety of the investigational drugs. 12. Other malignancies within the past 2 years except for non-melanoma skin cancer.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • University of Miami

    RECRUITING

    Miami, Florida, 33146, United States

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