Lenvatinib + Pembrolizumab for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

+168 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eisai Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer. Participants will be randomly assigned to receive either pembrolizumab and lenvatinib or treatment of physician's choice. The primary study hypothesis is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS) and overall survival (OS) when compared to treatment of physician's choice.

Research Team

Medical Director

Principal Investigator

Eisai Inc.

Eligibility Criteria

This trial is for adults with advanced endometrial cancer who've had one prior platinum-based chemotherapy. They must not be pregnant or breastfeeding and agree to use contraception. Excluded are those with certain other cancers, heart conditions, active infections, HIV/Hepatitis B/C, recent major surgery complications, autoimmune diseases requiring treatment in the past 2 years, or previous treatments that overlap with the study drugs.

Inclusion Criteria

Is not pregnant, breastfeeding, and agrees to use a highly effective method of contraception during the treatment period and for at least 120 days (for participants treated with lenvatinib plus pembrolizumab) or at least 180 days (for participants treated with treatment of physician's choice [TPC]) after the last dose of study treatment

My cancer progressed after 1 platinum-based treatment.

I have a tumor that can be measured and has been confirmed by a review.

Exclusion Criteria

My cancer is a specific type affecting the uterus.

I have received an organ or tissue transplant from another person.

I have had more than one chemotherapy treatment for endometrial cancer, but no more than two that included platinum.

Treatment Details

Interventions

• Doxorubicin (Antineoplastic Agent)
• Lenvatinib (Tyrosine Kinase Inhibitor)
• Paclitaxel (Antineoplastic Agent)
• Pembrolizumab (Monoclonal Antibodies)

Trial Overview The trial tests pembrolizumab combined with lenvatinib against a physician's choice of doxorubicin or paclitaxel in treating advanced endometrial cancer. The goal is to see if the combination improves survival without disease progression compared to standard treatments.

Participant Groups

Group I: Lenvatinib 20 mg + Pembrolizumab 200 mg Experimental Treatment 2 Interventions

Participants will receive pembrolizumab 200 milligram (mg) administered by intravenous (IV) infusion on Day 1 of each 21-day cycle plus lenvatinib 20 mg administered orally (PO) once daily (QD) during each 21-day cycle for up to 35 cycles.

Group II: Treatment of Physician's Choice Active Control 2 Interventions

Participants will receive either of the following treatments: doxorubicin 60 milligram per square meter (mg/m\^2) administered by IV on Day 1 of each 21-day cycle for up to a maximum cumulative dose of 500 mg/m\^2 OR paclitaxel 80 mg/m\^2 administered by IV on a 28-day cycle: 3 weeks receiving paclitaxel once a week and 1 week not receiving paclitaxel.

Who Is Running the Clinical Trial?

Eisai Inc.

Lead Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University