Study on Pembrolizumab and Lenvatinib for Recurrent Endometrial Cancer After Initial Treatment Failure
Sponsor: University of Miami
Sponsor score: 40
ClinicalTrials ID:NCT07594015
This clinical trial is testing the effectiveness and safety of combining Pembrolizumab and Lenvatinib for treating recurrent endometrial cancer that has not responded to initial platinum-based chemotherapy and immunotherapy.
Patient Parameters
| Parameter | Options |
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Program Overview
The aim of this study is to evaluate how well the combination of Pembrolizumab and Lenvatinib works in treating patients with recurrent endometrial cancer that is mismatch repair-proficient and has not responded to first-line treatment with platinum-based chemotherapy and immunotherapy.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with recurrent endometrial cancer, including specific subtypes like serous or clear cell, with measurable disease.
- Cancer must be mismatch repair-proficient, confirmed by specific tests.
- Must have previously received and not responded to first-line platinum-based chemotherapy and immunotherapy.
- Completed genetic sequencing on the tumor.
- General health status allowing participation, with an ECOG performance status of 0 to 3.
- Aged 18 years or older.
- Women must not be pregnant or breastfeeding and must agree to use contraception if of childbearing potential.
- Have at least one measurable tumor.
- Adequate organ function, including specific blood counts and kidney and liver function.
- Must provide written informed consent.
- At least 3 weeks since any previous cancer treatment.
Exclusion Criteria
- Have uterine sarcoma.
- Have active cancer spread to the brain or spinal fluid.
- Have severe allergies to Pembrolizumab, Lenvatinib, or their ingredients.
- Have an active autoimmune disease needing long-term steroid treatment recently.
- Are pregnant or breastfeeding.
- Have previously been treated with Lenvatinib or similar drugs.
- Are receiving other experimental drugs or cancer treatments, except certain hormonal therapies.
- Have uncontrolled illnesses, like active infections.
- Have high blood pressure that is not controlled.
- Have had major heart problems in the past year.
- Have had an organ transplant or are on immune-suppressing medications.
- Have had other cancers in the past two years, except for certain skin cancers.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Miami | 33146 | Miami | Florida |
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