Recurrent Endometrial CancerPhase 2NCT07594015
Pembrolizumab and Lenvatinib in Mismatch Repair Proficient Recurrent Endometrial Cancer After Progression on or Following First-Line Immunotherapy Maintenance
A Phase 2 study testing Pembrolizumab and Lenvatinib in people with Recurrent Endometrial Cancer, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy and safety of Pembrolizumab in combination with Lenvatinib in recurrent, mismatch repair-proficient endometrial cancer after failure of first-line therapy with a platinum-based doublet chemotherapy and immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Endometrial Cancer
- What is being tested?
- Pembrolizumab and Lenvatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2026to 31 Aug 2031
- 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
- Histologically confirmed recurrent endometrial carcinoma, including serous, endometrioid, carcinosarcoma, clear cell subtypes, with measurable disease per RECIST 1.1 criteria.
- Mismatch repair (MMR) proficient status confirmed by immunohistochemistry (IHC) or molecular testing.
- Patients must have progressed on or after first-line maintenance immunotherapy that was started while on carboplatin-based doublet chemotherapy and continued following chemotherapy until completion (prior chemotherapy for this disease administered before the most recent line is permitted).
- Prior radiation is permitted but not required.
- Patient must have completed next-generation sequencing on either primary or recurrent tumor.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3.
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- Age ≥ 18 years.
- Female participants must be of non-childbearing potential or for females of child bearing potential (FOCBPs), must agree to use contraception as described in protocol. FOCBPs must not be pregnant or breastfeeding.
- At least one measurable lesion according to RECIST 1.1.
- 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)
- Written informed consent obtained from the patient.
- At least 3 weeks must have elapsed from any prior therapy
Who cannot join
- Uterine sarcoma
- Active central nervous system metastases or leptomeningeal disease.
- History of severe allergic reactions to pembrolizumab, lenvatinib, or any components of the formulations.
- Active autoimmune disease requiring chronic systemic steroids for > 3 months in the last 6 months prior to enrollment.
- Pregnancy or breastfeeding at the time of enrollment.
- Previous treatment with lenvatinib or other VEGFR inhibitors.
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- Concurrent treatment with other investigational drugs or anti-cancer therapies except for adjuvant hormonal therapy for breast cancer.
- Uncontrolled concurrent illness, such as active infections that could interfere with study participation.
- Blood pressure >160 systolic or >110 diastolic averaged over last 3 documented measurements.
- 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).
- History of organ transplant or immune suppressive therapy that would interfere with the efficacy or safety of the investigational drugs.
- Other malignancies within the past 2 years except for non-melanoma skin cancer.
- Patients that have received more than one prior line of immunotherapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33146
Navya Nair, MD, MPH, 305-243-2233, navya.nair@miami.edu
Abdulrahman Sinno, MD, 305-243-2233, axs3193@miami.edu
About this study
Official title: Phase 2 Open-Label Trial Investigating the Efficacy and Safety of Pembrolizumab and Lenvatinib in Mismatch Repair Proficient Recurrent Endometrial Cancer After Progression on or Following First-Line Immunotherapy Maintenance
The purpose of this study is to determine the efficacy and safety of Pembrolizumab in combination with Lenvatinib in recurrent, mismatch repair-proficient endometrial cancer after failure of first-line therapy with a platinum-based doublet chemotherapy and immunotherapy.
- Conditions
- Recurrent Endometrial Cancer
- Being tested
- Pembrolizumab, Lenvatinib
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
Participants will receive 200mg of Pembrolizumab intravenously on Day 1 of every 21 day cycle, as per standard of care and as per institutional guidelines.
LenvatinibDrug
Also called Lenvima
Participants will self-administer Lenvatinib orally at a daily dose of 20mg or every 21 day cycle, as per standard of care and as per institutional guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab in combination with Lenvatinib | Experimental | Participants will receive Pembrolizumab in combination with Lenvatinib after failure of first-line therapy with a platinum-based doublet chemotherapy in combination with immunotherapy. Participants may receive treatment for a total of up to approximately 24 months, or until participants have progression of disease or experience a Grade 4 or higher severe adverse event (SAE).
Total participation duration is approximately 26 months. Receives: Drug: Pembrolizumab; Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Rate
Clinical benefit rate (CBR) is defined as the proportion of participants achieving complete response (CR), partial response (PR) or sustained stable disease (SD), as the best response as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
Measured: Baseline, Up to 18 weeks
Secondary outcomes (9)
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of participants achieving complete response (CR) or partial response (PR) as the best response assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
Measured: Up to 26 months
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is the elapsed time in months from date of treatment initiation until progression or death from any cause. Patients who are alive and without documented disease progression will be censored at the date of their last disease assessment.
Measured: Up to 26 months
Overall Survival (OS)
Overall Survival (OS) is the elapsed time in months from date of treatment initiation until death from any cause. Alive patients will be censored at the last date known to be alive.
Measured: Up to 26 months
Duration of Response (DOR)
Duration of Response (DOR) is the elapsed time in months from date of first documentation of complete response (CR) or partial response (PR) until first documentation of progression or death from any cause for responders. Patients who are alive and without documented disease progression will be censored at the date of their last disease assessment.
Measured: Up to 26 months
Number of Participants Experiencing Treatment-Related Toxicity: Serious Adverse Events (SAEs)
The safety and tolerability of combination Pembrolizumab and Lenvatinib therapy will be reported as the number of participants experiencing treatment-related serious adverse events (SAEs). SAEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Measured: Up to 26 months
Number of Participants Experiencing Treatment-Related Toxicity: Adverse Events (AEs)
The safety and tolerability of combination Pembrolizumab and Lenvatinib therapy will be reported as the number of participants experiencing treatment-related adverse events (AEs). AEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Measured: Up to 26 months
Health-Related Quality of Life Scores: Patient-Reported Outcomes via EORTC QLQ-17
Participant quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 17 (EORTC QLQ-17), a validated 17-item questionnaire measuring global health status and functional domains relevant to cancer patients. Items are scored using standardized Likert scales and converted to 0-100 domain scores according to EORTC scoring guidelines. Higher scores indicate better functioning and overall quality of life.
Measured: Up to 26 months
Health-Related Quality of Life Scores: Patient-Reported Social Isolation via Social Provisions Scale - 10 items (SPS-10)
Social isolation will be measured using the 10-item short form of the Social Provisions Scale, a validated instrument assessing perceived social support and relational connectedness. Each item is rated on a 4-point Likert scale (1 = Strongly Disagree, 2 = Disagree, 3= Agree, 4 = Strongly Agree), yielding a total score ranging from 10 to 40, with higher scores indicating greater perceived social support (lower social isolation).
Measured: Up to 26 months
Health-Related Quality of Life Scores: Patient-Reported Social Needs via Health Leads 10-Item Screening Tool
Unmet social needs will be assessed using the 10-item Health Leads Social Needs Screening Tool, a validated questionnaire identifying needs such as food insecurity, housing instability, transportation barriers, and utility challenges. Each item is coded as 1 (unmet need present) or 0 (no unmet need). Total scores represent the count of unmet social needs (range 0-10), with higher scores indicating greater social needs burden.
Measured: Up to 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start6 Aug 2026
- Primary completion31 Aug 2031 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Endometrial CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Navya Nair, M.D., M.P.H, University of Miami
- Investigators
- Navya Nair, MD, MPH, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594015
- Sponsor's protocol ID
- 20251180
- Other IDs
- NCI-2026-03505
- Status last verified
- Aug 2026
- First submitted
- 11 May 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Open-Label Trial Investigating the Efficacy and Safety of Pembrolizumab and Lenvatinib in Mismatch Repair Proficient Recurrent Endometrial Cancer After Progression on or Following First-Line Immunotherapy Maintenance
- ClinicalTrials.gov ID
- NCT07594015
- Acronym / sponsor ID
- 20251180
- Conditions
- Recurrent Endometrial Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- 31 Aug 2031 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy and safety of Pembrolizumab in combination with Lenvatinib in recurrent, mismatch repair-proficient endometrial cancer after failure of first-line therapy with a platinum-based doublet chemotherapy and immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab in combination with Lenvatinib | Experimental | Drug: Pembrolizumab, Drug: LenvatinibParticipants will receive Pembrolizumab in combination with Lenvatinib after failure of first-line therapy with a platinum-based doublet chemotherapy in combination with immunotherapy. Participants may receive treatment for a total of up to approximately 24 months, or until participants have progression of disease or experience a Grade 4 or higher severe adverse event (SAE). Total participation duration is approximately 26 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically confirmed recurrent endometrial carcinoma, including serous, endometrioid, carcinosarcoma, clear cell subtypes, with measurable disease per RECIST 1.1 criteria.
- Mismatch repair (MMR) proficient status confirmed by immunohistochemistry (IHC) or molecular testing.
- Patients must have progressed on or after first-line maintenance immunotherapy that was started while on carboplatin-based doublet chemotherapy and continued following chemotherapy until completion (prior chemotherapy for this disease administered before the most recent line is permitted).
- Prior radiation is permitted but not required.
- Patient must have completed next-generation sequencing on either primary or recurrent tumor.
Key exclusion criteria (13 listed)
- Uterine sarcoma
- Active central nervous system metastases or leptomeningeal disease.
- History of severe allergic reactions to pembrolizumab, lenvatinib, or any components of the formulations.
- Active autoimmune disease requiring chronic systemic steroids for > 3 months in the last 6 months prior to enrollment.
- Pregnancy or breastfeeding at the time of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: KeytrudaParticipants will receive 200mg of Pembrolizumab intravenously on Day 1 of every 21 day cycle, as per standard of care and as per institutional guidelines. | Drug | Pembrolizumab in combination with Lenvatinib |
| LenvatinibAlso: LenvimaParticipants will self-administer Lenvatinib orally at a daily dose of 20mg or every 21 day cycle, as per standard of care and as per institutional guidelines. | Drug | Pembrolizumab in combination with Lenvatinib |
Primary outcome
Clinical Benefit Rate
Time frame: Baseline, Up to 18 weeks
Clinical benefit rate (CBR) is defined as the proportion of participants achieving complete response (CR), partial response (PR) or sustained stable disease (SD), as the best response as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
9 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 26 months
Progression-Free Survival (PFS)
Time frame: Up to 26 months
Overall Survival (OS)
Time frame: Up to 26 months
Duration of Response (DOR)
Time frame: Up to 26 months
Number of Participants Experiencing Treatment-Related Toxicity: Serious Adverse Events (SAEs)
Time frame: Up to 26 months
Number of Participants Experiencing Treatment-Related Toxicity: Adverse Events (AEs)
Time frame: Up to 26 months
Health-Related Quality of Life Scores: Patient-Reported Outcomes via EORTC QLQ-17
Time frame: Up to 26 months
Health-Related Quality of Life Scores: Patient-Reported Social Isolation via Social Provisions Scale - 10 items (SPS-10)
Time frame: Up to 26 months
Health-Related Quality of Life Scores: Patient-Reported Social Needs via Health Leads 10-Item Screening Tool
Time frame: Up to 26 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Navya Nair, MD, MPH principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab and Lenvatinib in people with Recurrent Endometrial Cancer, run by University of Miami 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 17 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 24 Sep 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 Navya Nair, MD, MPH (305-243-2233, navya.nair@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Benefit Rate (time frame: Baseline, Up to 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2026.