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New treatment option for Recurrent Endometrial Cancer
Official title Pembrolizumab and Lenvatinib in Mismatch Repair Proficient Recurrent Endometrial Cancer After Failure of First-Line Therapy With Platinum-based Doublet and Immunotherapy
ClinicalTrials.gov ID: NCT07594015
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent endometrial cancer.
Also referred to as Keytruda.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Histologically confirmed recurrent endometrial carcinoma, including serous, endometrioid, carcinosarcoma, clear cell subtypes, with measurable...
- Mismatch repair (MMR) proficient status confirmed by IHC (Immunohistochemistry) or molecular testing.
- Patients must have failed first-line therapy with platinum based doublet with prior immunotherapy.
- Patient must have completed next-generation sequencing on either primary or recurrent tumor.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3.
You likely can't join if
- 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.
See the full eligibility criteria
- 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 IHC (Immunohistochemistry) or molecular testing.
- Patients must have failed first-line therapy with platinum based doublet with prior immunotherapy.
- Patient must have completed next-generation sequencing on either primary or recurrent tumor.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3.
- 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 Section 5.6. 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
- 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.
- 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 how well it works or safety of the investigational drugs.
- Other malignancies within the past 2 years except for non-melanoma skin cancer.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.