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

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

FACILITYZIPCITYSTATE
University of Miami33146MiamiFlorida

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