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Addition of Pembrolizumab to Radiation Treatment for Newly Diagnosed Early Stage MSI-High Endometrial Cancer

Addition of Pembrolizumab to Radiation Treatment for Newly Diagnosed Early Stage MSI-High Endometrial Cancer

Clinicaltrials.gov identifier:
NCT04214067

Treatment:
Endometrial

Study Contact Information:

Principal Investigator: Floor Backes    

For additional information: Use the contacts listed per each study location. 


Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to the Usual Radiation Treatment for Newly Diagnosed Early Stage High Intermediate Risk Endometrial Cancer

About the Study

The purpose of this study is to determine whether the addition of the immunotherapy agent, pembrolizumab (Keytruda) to radiation therapy is more effective than radiation therapy alone in reducing the risk of cancer recurrence in patients with newly diagnosed stage I-II endometrial cancer that is MSI-High.


Type of Study

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

  • The study has 2-arms
    • Patients assigned to group 1 will receive standard-of-care radiation
    • Patients assigned to group 2 will receive standard-of-care radiation and immunotherapy
  • 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 treatment

Patients will undergo pelvic external beam radiation therapy (EBRT) daily for 5-6 weeks and vaginal brachytherapy completed within 7 days after completion of EBRT in the absence of disease progression or until treatment discontinuation for another reason.

Group 2 treatment

Patients will undergo EBRT and brachytherapy as in Group 1. Within 7 days prior to the start of radiation therapy, patients in Group 2 will also receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment with pembrolizumab repeats every 6 weeks for up to 1 year (9 cycles) in the absence of disease progression or until treatment discontinuation for another reason.

Followup

After completion of study treatment, patients are followed-up every 3 months for 2 years and then every 6 months for 3 years.


Study Sites

Alabama California Connecticut Florida Georgia
Idaho Illinois Iowa Kentucky Louisiana
Maine Michigan Minnesota Missouri Montana
Nebraska Nevada New Jersey New Mexico New York
North Carolina North Dakota Ohio Oklahoma Oregon
Pennsylvania Rhode Island South Dakota Texas Utah
Virginia Washington West Virginia Wisconsin  


Alabama

  • Birmingham: University of Alabama at Birmingham Cancer Center
    Contact: Tracey Myrick by phone: 205-934-0220 or by email         

California

  • Concord: John Muir Medical Center-Concord Campus
    Contact: 925-674-2580
  • La Jolla: UC San Diego Moores Cancer Center
    Contact: UCSD Clinical Trial Office by phone: 858-822-5354 or by email
  • Los Angeles: UCLA / Jonsson Comprehensive Cancer Center
    Contact: UCLA Clinical Trial Office by phone: 888-798-0719
  • Walnut Creek: John Muir Medical Center-Walnut Creek     
    Contact: 925-941-4246        

Connecticut

  • New Haven: Smilow Cancer Center/Yale-New Haven Hospital    
    Contact: 203-785-5702 or by email     
  • New Haven: 

Florida

  • Fort Myers: Florida Gynecologic Oncology
    Contact: 800-874-7502       

Georgia

  • Atlanta: Northside Hospital    
    Contact: 404-303-3355 or by email      
  • Marietta: Wellstar Kennestone Hospital          
    Contact: 470-793-4071 or by email    
  • Newnan: CTCA at Southeastern Regional Medical Center       
    Contact: 770-400-6629
  • Savannah: Lewis Cancer and Research Pavilion at Saint Joseph's/Candler       
    Contact: 912-819-5704 or by email     

Idaho

  • Boise: Saint Luke's Cancer Institute - Boise 
    Contact: 208-381-2774 or by email
  • Fruitland: Saint Luke's Cancer Institute - Fruitland       
    Contact: 208-381-2774 or by email        
  • Meridian: Saint Luke's Cancer Institute - Meridian
    Contact: 208-381-2774 or by email
  • Nampa: Saint Luke's Cancer Institute - Nampa
    Contact: 208-381-2774 or by email
  • Twin Falls: Saint Luke's Cancer Institute - Twin Falls
    Contact: 208-381-2774 or by email

Illinois

  • Centralia: Centralia Oncology Clinic      
    Contact: 217-876-4740 or by email     
  • Chicago: Northwestern University      
    Contact: 312-695-1301 or by email     
  • Chicago: University of Chicago Comprehensive Cancer Center          
    Contact: 773-702-8222 or by email
  • Decatur: Cancer Care Specialists of Illinois - Decatur  
    Contact: 217-876-4740 or by email
  • Decatur: Decatur Memorial Hospital  
    Contact: 217-876-4740 or by email
  • Effingham: Crossroads Cancer Center     
    Contact: 217-876-4740 or by email 
  • Evanston: NorthShore University HealthSystem-Evanston Hospital    
    Contact:  847-570-2109
  • Geneva: Northwestern Medicine Cancer Center Delnor  
    Contact: 630-352-5360 or by email  
  • Glenview: NorthShore University HealthSystem-Glenbrook Hospital  
    Contact: 847-570-2109
  • Highland Park: NorthShore University HealthSystem-Highland Park Hospital         
    Contact: 847-570-2109
  • New Lenox: UC Comprehensive Cancer Center at Silver Cross    
    Contact:  773-702-8222 or by email
  • O'Fallon: Cancer Care Center of O'Fallon         
    Contact: 217-876-4762 or by email 
  • Orland Park: University of Chicago Medicine-Orland Park
    Contact: 773-702-8222 or by email
  • Springfield: Southern Illinois University School of Medicine       
    Contact: 217-545-7929
  • Springfield: Springfield Clinic        
    Contact: 800-444-7541
  • Springfield: Memorial Medical Center     
    Contact: 217-788-3528
  • Warrenville: Northwestern Medicine Cancer Center Warrenville
    Contact: 630-352-5360 or by email
  • Zion: Midwestern Regional Medical Center          
    Contact: 412-339-5294 or by email     

Iowa

  • Ames: Mary Greeley Medical Center
    Contact: Site Public Contact    515-956-4132
  • Ames: McFarland Clinic PC - Ames   
    Contact: 515-239-4734 or by email           

Kentucky

  • Edgewood: Saint Elizabeth Medical Center South
    Contact: 859-301-5473 or by email 
  • Lexington: Baptist Health Lexington       
    Contact: 859-260-6425     

Louisiana

  • Metairie: East Jefferson General Hospital        
    Contact: 504-210-3539 or by email
  • New Orleans: Louisiana State University Health Science Center   
    Contact: 504-210-3539 or by email      
  • New Orleans: University Medical Center New Orleans       
    Contact: 504-210-3539 or by email  

Maine

  • Bath: MaineHealth Coastal Cancer Treatment Center       
    Contact: 412-339-5294 or by email
  • Biddeford: MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford  
    Contact: by email
  • Portland: Maine Medical Center-Bramhall Campus     
    Contact: 207-885-7565
  • Sanford: MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford      
    Contact: by email
  • Scarborough: Maine Medical Center- Scarborough Campus          
    Contact: 207-396-8090 or by email     

Michigan

  • Dearborn: Beaumont Hospital - Dearborn         
    Contact: 248-551-7695
  • Detroit: Wayne State University/Karmanos Cancer Institute
    Contact: 313-576-9790 or by email     
  • Farmington Hills: Weisberg Cancer Treatment Center 
    Contact:  313-576-9790 or by email  
  • Royal Oak: William Beaumont Hospital-Royal Oak         
    Contact: 248-551-7695
  • Troy: William Beaumont Hospital - Troy    
    Contact: 248-551-7695       

Minnesota

  • Edina: Fairview Southdale Hospital 
    Contact: 952-993-1517 or by email
  • Minneapolis: Abbott-Northwestern Hospital         
    Contact:  952-993-1517 or by email
  • Monticello: Monticello Cancer Center     
    Contact: 952-993-1517 or by email
  • Saint Cloud: Coborn Cancer Center at Saint Cloud Hospital         
    Contact: 877-229-4907 or by email  
  • Waconia: Ridgeview Medical Center    
    Contact: 952-993-1517 or by email      

Missouri

  • Farmington: Parkland Health Center - Farmington
    Contact: 314-996-5569
  • Saint Louis: Washington University School of Medicine  
    Contact: 800-600-3606 or by email      
  • Saint Louis: Missouri Baptist Medical Center       
    Contact: 314-996-5569     
  • Saint Louis: Mercy Hospital Saint Louis    
    Contact: 314-251-7066
  •  Sainte Genevieve: Sainte Genevieve County Memorial Hospital
    Contact: 314-996-5569
  • Springfield: Mercy Hospital Springfield    
    Contact: 417-269-4520
  • Sullivan: Missouri Baptist Sullivan Hospital    
    Contact: 314-996-5569
  • Sunset Hills: Missouri Baptist Outpatient Center-Sunset Hills      
    Contact: 314-996-5569        

Montana

  • Bozeman: Bozeman Deaconess Hospital
    Contact: 406-969-6060 or by email     

Nebraska

  • Omaha: Nebraska Methodist Hospital
    Contact: 402-354-5144     

Nevada

  • Las Vegas: Women's Cancer Center of Nevada  
    Contact: 702-693-6870 or by email       

New Jersey

  • Basking Ridge: Memorial Sloan Kettering Basking Ridge      
    Contact: 212-639-7592
  • Middletown: Memorial Sloan Kettering Monmouth          
    Contact: 212-639-7592
  • Montvale: Memorial Sloan Kettering Bergen     
    Contact: 212-639-7592         

New Mexico

  • Albuquerque: University of New Mexico Cancer Center     
    Contact: 505-925-0366 or by email      

New York

  • Albany: Women's Cancer Care Associates LLC           
    Contact: 518-458-1390 or by email
  • Brooklyn: New York-Presbyterian/Brooklyn Methodist Hospital         
    Contact: 718-780-3677 or by email
  • Commack: Memorial Sloan Kettering Commack
    Contact: 212-639-7592
  • Flushing: The New York Hospital Medical Center of Queens   
    Contact: 412-339-5294 or by email
  • Harrison: Memorial Sloan Kettering Westchester        
    Contact:  212-639-7592
  • Lake Success: Northwell Health/Center for Advanced Medicine    
    Contact: 516-734-8896
  • New Hyde Park: Long Island Jewish Medical Center   
    Contact: 516-734-8896
  • New York: Memorial Sloan Kettering Cancer Center     
    Contact: 212-639-7592
  • Stony Brook: Stony Brook University Medical Center        
    Contact: 800-862-2215
  • Uniondale: Memorial Sloan Kettering Nassau     
    Contact: 212-639-7592          

North Carolina

  • Chapel Hill: UNC Lineberger Comprehensive Cancer Center       
    Contact: 877-668-0683 or by email
  • Greensboro: Cone Health Cancer Center   
    Contact: 336-832-0821 or by email      

North Dakota

  • Bismarck: Sanford Bismarck Medical Center     
    Contact: 701-323-5760 or by email 
  • Fargo: Sanford Broadway Medical Center   
    Contact: 701-323-5760 or by email
  • Fargo: Sanford Roger Maris Cancer Center  
    Contact: 701-234-6161 or by email     

Ohio

  • Centerville: Dayton Physicians LLC-Miami Valley South  
    Contact: 937-528-2900 or by email         
  • Centerville: Miami Valley Hospital South 
    Contact: 937-528-2900 or by email
  • Cleveland: MetroHealth Medical Center
    Contact: 216-778-8526 or by email
  • Columbus: Ohio State University Comprehensive Cancer Center          
    Contact: 800-293-5066 or by email
  • Columbus: Riverside Methodist Hospital
    Contact:  614-566-4475 or by email     

Oklahoma

  • Oklahoma: University of Oklahoma Health Sciences Center      
    Contact: 405-271-8777 or by email      

Oregon

  • Clackamas: Clackamas Radiation Oncology Center         
    Contact: 503-215-2614 or by email           
  • Providence Cancer Institute Clackamas Clinic          
    Contact: 503-215-2614 or by email 
  • Gresham: Legacy Mount Hood Medical Center
    Contact: 503-413-2150
  • Newberg: Providence Newberg Medical Center
    Contact:  503-215-2614 or by email   
  • Portland: Legacy Good Samaritan Hospital and Medical Center         
    Contact: 800-220-4937 or by email          
  • Portland: Providence Portland Medical Center
    Contact:  503-215-2614 or by email
  • Portland: Providence Saint Vincent Medical Center     
    Contact: 503-215-2614 or by email  
  • Tualatin: Legacy Meridian Park Hospital         
    Contact: 503-413-1742     

Pennsylvania

  • Lancaster: Lancaster General, Ann B Barshinger Cancer Institute          
    Contact: Site Public Contact    717-544-0511
  • Paoli: Paoli Memorial Hospital       
    Contact:  484-476-2649 or by email     
  • Philadelphia: University of Pennsylvania/Abramson Cancer Center          
    Contact: Site Public Contact    800-474-9892 
  • Philadelphia: Pennsylvania Hospital
    Contact: 800-789-7366
  • Philadelphia: Thomas Jefferson University Hospital          
    Contact: 215-955-6084 
  • West Chester: Chester County Hospital       
    Contact: Site Public Contact    610-431-5297     
    Willow Grove: Abington Memorial Hospital-Asplundh Cancer Pavilion      
    Contact: 215-481-2402
  • Wynnewood: Lankenau Medical Center     
    Contact: 484-476-2649 or by email   

Rhode Island

  • Providence: Women and Infants Hospital
    Contact: 401-274-1122       

South Dakota

  • Sioux Falls: Sanford Cancer Center Oncology Clinic        
    Contact: 605-312-3320 or by email
  • Sioux Falls: Sanford USD Medical Center - Sioux Falls
    Contact: 605-312-3320 or by email        

Texas

  • Dallas: Parkland Memorial Hospital 
    Contact: 214-590-5582 or by email
  • Dallas:UT Southwestern/Simmons Cancer Center-Dallas   
    Contact: 214-648-7097 or by email     
  • Houston: Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center 
    Contact:  713-798-1354 or by email      
  • Houston: Houston Methodist Hospital 
    Contact: 713-790-2700
  • Houston: Methodist Willowbrook Hospital      
    Contact: 412-339-5294 or by email
  • Sugar Land: Houston Methodist Sugar Land Hospital      
    Contact: Site Public Contact    281-242-2873             

Utah

  • Farmington: Farmington Health Center    
    Contact: 888-424-2100 or by email
  • Salt Lake City: University of Utah Sugarhouse Health Center          
    Contact: 888-424-2100 or by email
  • Salt Lake City: Huntsman Cancer Institute/University of Utah        
    Contact: 888-424-2100 or by email     

Virginia

  • Richmond: VCU Massey Cancer Center at Stony Point   
    Contact: 804-628-1939 or by email
  • Richmond: Virginia Commonwealth University/Massey Cancer Center
    Contact: 804-628-1914 or by email        

Washington

  • Vancouver: Legacy Salmon Creek Hospital          
    Contact: 503-413-2150           

West Virginia

  • Charleston: West Virginia University Charleston Division
    Contact: 304-388-9944         

Wisconsin

  • Brookfield: Ascension Southeast Wisconsin Hospital - Elmbrook Campus         
    Contact: 414-635-6420 or by email
  • Eau Claire: Marshfield Medical Center-EC Cancer Center          
    Contact: 800-782-8581 or by email
  • Franklin: Ascension Saint Francis - Reiman Cancer Center
    Contact: 800-782-8581 or by email      
  • Franklin: Ascension Southeast Wisconsin Hospital - Franklin
    Contact: 800-782-8581 or by email
  • La Crosse: Gundersen Lutheran Medical Center
    Contact: 608-775-2385 or by email
  • Madison: University of Wisconsin Hospital and Clinics
    Contact: Site Public Contact    800-622-8922
  • Mequon: Ascension Columbia Saint Mary's Hospital Ozaukee
    Contact: 414-635-6420  or by email
  • Milwaukee: Ascension Southeast Wisconsin Hospital - Saint Joseph Campus    
    Contact: 414-635-6420 or by email 
  • Milwaukee: Ascension Columbia Saint Mary's Hospital - Milwaukee
    Contact: 414-635-6420 or by email
  • Milwaukee: Ascension Saint Francis Hospital      
    Contact: 414-635-6420 or by email
  • Milwaukee: Medical College of Wisconsin
    Contact: 414-805-3666
  • Racine: Ascension All Saints Hospital
    Contact: 414-635-6420 or by email
  • Stevens Point: Marshfield Clinic Stevens Point Center         
    Contact:  800-782-8581 or by email
  • Wauwatosa: Ascension Medical Group Southeast Wisconsin - Mayfair Road      
    Contact: 414-635-6420 or by email   
  • Weston: Marshfield Medical Center - Weston
    Contact:  800-782-8581 or by email  
This Study is Open To:

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

Stage I endometrial cancer and a combination of age and risk factors as listed below:

  • Age >= 70 and >= 1 risk factor
  • Age 50 - < 70 and 2 risks factors
  • Age < 50 and 3 risk factors
  • Risk factors:
    • Myometrial invasion >= 50%
    • Lymphovascular space invasion
    • Grade 2 or 3 tumor OR

Or

Stage II endometrial cancer

  • Imaging showing no evidence of disease outside of the uterus
  • Tumor shows mismatch repair deficiency (dMMR) and/or microsatellite instability high (MSI-high)
  • Undergone surgical staging with at least hysterectomy, removal of cervix, bilateral salpingo-oophorectomy, and either sentinel lymph node assessment or complete pelvic +/- aortic lymphadenectomy.
  • Received no prior therapy for endometrial cancer, including hormonal therapy, chemotherapy, targeted therapy, immunotherapy or radiation therapy
This Study is Not Open To:
  • Participated in or are currently receiving cancer-directed study therapy for endometrial cancer (4-week washout period prior to study registration is required)
  • Received prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapeutic antibody or other similar agents
  • A history of autoimmune disease that might recur and require immune suppressive treatment. (Contact the study team to review a list of exceptions).
  • A history of (non-infectious) pneumonitis requiring steroids
  • A diagnosis of immunodeficiency or are receiving immunosuppressive therapy (Contact the study team to review a list of exceptions).
  • Significant liver disease
  • Uncontrolled other illness that might interfere with endometrial cancer diagnosis including, but not limited to: infections, lung disease, significant cardiac disease, or psychiatric illness