About the Study

The purpose of this study is to compare the effectiveness of using a combination of the immunotherapy drug pembrolizumab (Keytruda) and the targeted therapy lenvatinib (Lenvima) in women with Stage III, IV, or recurrent endometrial cancer versus using chemotherapy treatment alone. NOTE: This study has completed enrollment.

Type of Study

This is a 2-arm, randomized, open-label, phase 3 study.  

• The study has two arms, which means patients will be placed into one of two groups. 
  • Patients assigned to Group 1 will receive will receive lenvatinib and pembrolizumab
  • Patients assigned to Group 2 will receive the chemotherapy drugs paclitaxeland carboplatin
• The study is randomized. Patients will be selected by chance and placed into one of the two groups.
• The study is open-label, all patients will know which group they have been placed into. 

What the Study Entails

• Group 1 participants will take lenvatinib daily (orally) and will receive pembrolizumab intravenously once at the start of each 3-week treatment cycle.
• Group 2 participants will receive chemotherapy medications paclitaxel intravenously and carboplatin intravenously on Day 1 of each 3-week treatment cycle.  

Follow up

• Progression-free survival (the length of time that a patient survives without progression of the disease) of patients in this study will be measured for up to approximately 31 months.
• Overall survival of patients will be followed for up to approximately 45 months.

Study Sites

Alabama

• Mobile: University of South Alabama, Mitchell Cancer Institute
  Contact: 251-445-9834     

Arizona

• Tucson: Arizona Oncology Associates PC- HOPE
  Contact: 281-863-6507   

California

• Los Angeles: UCLA Hematology and Oncology Clinic (Westwood) 
  Contact: 310-794-6982     

Colorado

• Aurora: University of Colorado Cancer Center   
  Contact: 303-724-2066     

Connecticut

• New Haven: Smilow Cancer Hospital at Yale New Haven       
  Contact: 203-785-6398     

Georgia

• Augusta: Georgia Cancer Center at Augusta University
  Contact: 706-721-4805     

Louisiana

• Covington: Women's Cancer Care 
  Contact: 985-892-2252     

Maine

• Scarborough: Maine Medical Partners
  Contact: 207-396-8376     

Minnesota

• Minneapolis: Minnesota Oncology Hematology, PA 
  Contact: 281-863-6507     

New Jersey

• Basking Ridge: Memorial Sloan-Kettering Cancer Center At Basking Ridge 
  Contact: 646-888-4224
• Hackensack: John Theurer Cancer Center at Hackensack University Med Ctr         
  Contact: 551-996-4716
• Middletown: Memorial Sloan Kettering Cancer Center- Monmouth
  Contact: 646-888-4466
• Montvale: MSKCC-Bergen   
  Contact: 646-888-4466
• Teaneck: Holy Name Medical Center      
  Contact: 201-227-6200     

New York

• Commack: Memorial Sloan-Kettering Cancer Center at Commack
  Contact: 646-888-4466     
• Harrison: Memorial Sloan Kettering Cancer Center - West Harrison        
  Contact: 646-888-4424
• New York City:The Blavatnik Family- Chelsea Medical Center at Mount Sinai 
  Contact: 212-604-6059
• New York City: Memorial Sloan Kettering Cancer Center      
  Contact: 646-888-4224 
• Rochester: University of Rochester  
  Contact: 585-275-5345
• Uniondale: Memorial Sloan Kettering Cancer Center - Nassau
  Contact: 646-888-4466     

North Carolina

• Chapel Hill: University of North Carolina- Chapel Hill
  Contact: 919-966-4432  

North Dakota

• Fargo: Roger Maris Cancer Center      
  Contact: 605-312-3250     

Oregon

• Eugene: Willamette Valley Cancer Institute and Research Center         
  Contact: 281-863-6507     

South Dakota

• Sioux Falls: Sanford Cancer Center Oncology Clinic
  Contact: 605-312-3343     

Texas

• Dallas: Parkland Health & Hospital System 
  Contact: 214-648-7097
• Dallas: University of Texas Southwestern Medical Center
  Contact: 214-648-3026
• The Woodlands: Texas Oncology-The Woodlands
  Contact: 281-863-6507     

Washington

• Vancouver: Legacy Salmon Creek Medical Center    
  Contact: 503-413-8654