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Pembrolizumab Plus Lenvatinib Versus Chemotherapy for Endometrial Cancer

Pembrolizumab Plus Lenvatinib Versus Chemotherapy for Endometrial Cancer

Clinicaltrials.gov identifier:
NCT03884101

Treatment:
Endometrial

Study Contact Information:

For additional information, please contact: 1-888-577-8839 or Trialsites@merck.com


Pembrolizumab Plus Lenvatinib Versus Chemotherapy for Endometrial Cancer

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.

Type of Study

This is a 2-arm, randomizedopen-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 Arizona California Colorado Connecticut
Georgia Louisiana Maine Minnesota New Jersey
New York North Carolina North Dakota Oregon South Dakota
Texas Washington      

 

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     
This Study is Open To:

Women, age 18 years or older, are eligible if they:

  • Have Stage III, Stage IV, or recurrent endometrial cancer
  • Have provided tumor tissue sample or newly obtained biopsy of a tumor lesion that was not previously irradiated
  • Are not pregnant or breastfeeding
  • Have adequate organ function
This Study is Not Open To:

Women with the following are not eligible: 

  • Received prior systemic chemotherapy for the treatment of endometrial cancer
  • Spread to the brain or spinal cord (central nervous system metastasis)
  • Another cancer that has gotten worse or has required active treatment in the last 3 years
  • Any of the following types of endometrial cancer:
    • carcinosarcoma or malignant mixed Műllerian tumor, endometrial leiomyosarcoma or other high-grade sarcomas, or endometrial stromal sarcomas 
  • Significant heart disease
  • History of HIV, Hepatitis B or Hepatitis C, or active tuberculosis
  • History of (non-infectious) inflammation of lung tissue (pneumonitis)
  • Active autoimmune disease (with the exception of psoriasis) that has required systemic treatment in the past 2 years