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MK-7902-001

Trial

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

July 12, 2019

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

Principal Investigator Name

Colleen McCormick, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Monday, March 22, 2021 02:43:45 PM