MK-7902-001

Clinical Trial Title A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001)
Trial Status Closed to Enrollment
Start Date 07/12/2019
Location Doctors & Locations
Trial Type Cancer - Adult Oncology
Specific Condition Endometrial carcinoma
Description The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS).
Eligibility Criteria

Eligibility Criteria

  • Have Stage III, Stage IV, or recurrent, histologically-confirmed endometrial carcinoma with disease that is either measurable or non-measurable per RECIST 1.1 but radiographically apparent, as assessed by BICR.
  • May have received prior chemotherapy only if administered concurrently with radiation
  • May have received prior radiation
  • May have received prior hormonal therapy for treatment of endometrial carcinoma, provided that it was discontinued ≥1 week prior to randomization

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.
IRB Number Central IRB
Notes

https://clinicaltrials.gov/ct2/show/NCT03884101?term=mk7902-001
Principal Investigator Colleen McCormick, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org