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Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel for Recurrent or Primary Advanced Endometrial Cancer (RUBY)

Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel for Recurrent or Primary Advanced Endometrial Cancer (RUBY)

Clinicaltrials.gov identifier:
NCT03981796

Treatment:
Endometrial

Study Contact Information:

For additional information, please contact: US GSK Clinical Trials Call Center by phone:  877-379-3718 or by email: GSKClinicalSupportHD@gsk.com          


Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel for Recurrent or Primary Advanced Endometrial Cancer (RUBY)

About the Study

This study for people with Stage III or Stage IV endometrial cancer will look at how well the combination of the immunotherapy dostarlimab (Jemperli), the targeted therapy niraparib (Zejula) and chemotherapy works compared with chemotherapy alone. 

Type of Study:

This is a randomized, double-blinded study divided into two groups. Participants will be placed into one of the groups by chance (randomized). Neither the participant, nor their doctor will know which group they are in (blinded).  

What the Study Entails

Group 1 and Group 2 of this study are closed to enrollment, the remaining two groups are Group 3 and Group 4.   

  • Group 3: People in this group will receive the chemotherapy combination carboplatin-paclitaxel + the targeted therapy dostarlimab, followed by dostarlimab+ the targeted therapy niraparib.
  • Group 4: People in this group will receive the chemotherapy combination carboplatin-paclitaxel + a placebo, followed by a placebo.

Study participants will be followed for up to 6 years and 9 months.

Study Sites

Arizona

  • Mesa
    Arizona Oncology
    Dana Chase, MD
  • Phoenix
    Arizona Oncology    
    Dana Chase, MD       
  • Tucson, Arizona
    Arizona Oncology
    Joseph Buscema, MD        

California

  • Newport Beach
    Hoag
    Alberto Mendivil   
  • Palo Alto
    Stanford Health Care
    Elisabeth Diver, MD       

Florida

  • Deerfield Beach
    University of Miami
    Matthew Schlumbrecht, MD        
  • Jacksonville
    Baptist Hospital
    Paul Nowicki, MD
  • Miami
    University of Miami
    Matthew Schlumbrecht, MD 
  • Miami
    Baptist Health 
    John Diaz, MD
  • Orlando
    Advent Health     
    Robert W Holloway, MD        

Georgia

  • Atlanta
    Northside Hospital
    Guilherme Cantuaria, MD     
  • Augusta
    Augusta Oncology
    Sharad A Ghamande, MD
  • Savannah
    St. Josephs/Candler
    Sarah Gill, MD        

Illinois

  • Hinsdale
    Advent Health
    Sudarshan K. Sharma, MD        
  • Zion
    Cancer Treatment Centers of America
    Julian Schink, MD        

Indiana

  • Fort Wayne
    Parkview Health
    Iwona Podzielinski, MD 
  • Indianapolis 
    Indiana University Health
    Paul Mayor, MD
  • Indianapolis
    Ascension Medical Group, St. Vincent's Health Care        
    Michael Callahan, MD        

Iowa

  • Iowa City
    University of Iowa
    David Bender, MD         

Kentucky

  • Lexington
    University of Kentucky
    Rachel Miller, MD        

Louisiana

  • Covington
    St. Tammany Health System
    Patricia S Braly, MD    
  • New Orleans
    Oschner Health
    Katrina Wade     
  • Shreveport
    Louisiana State University
    Destin Black, MD        

Massachusetts

  • Boston
    Massachusetts General Hospital 
    Oladapo Yeku, MD     
  • Springfield
    Baystate Health
    Tashanna Myers, MD        

Michigan

  • Detroit
    Karmanos Cancer Center
    Radhika P Gogoi, MD        

Missouri

  • Saint Louis
    Washington University
    Matthew A Powell, MD        

New Hampshire

  • Lebanon
    Dartmouth-Hitchcock
    Evelyn L Fleming, MD        

New Mexico

  • Albuquerque
    University of New Mexico
    Sarah Adams, MD      
  • Rio Rancho
    University of New Mexico
    Sarah Adams, MD        

New York

  • Albany
    Joyce Barlin, MD        
  • Bronx
    Montefiore Medical Center
    Nicole Nevadunsky, MD     
  • New York
    NYU Langone
    Bhavana Pothuri, MD        

North Carolina

  • Charlotte
    Novant Health
    Kellie Schneider, MD     
  • Durham
    Duke Medical Center
    Angeles Alvarez Secord, MD 
  • Kernersville
    Novant Health
    Joshua Trinidad, DO        
  • Mount Airy, North Carolina 27030
    Novant Health
    Joshua Trinidad, DO       
  • Winston-Salem, North Carolina 27103
    Novant Health
    Joshua Trinidad, DO      

Ohio

  • Cincinnati
    University of Cincinnati
    Caroline Billingsley, MD      
  • Cleveland 
    Case Western
    Amy Armstrong, MD    
  • Columbus
    The Ohio State University James Cancer Center
    Floor Backes, MD        

Oklahoma

  • Tulsa
    Oklahoma Cancer Specialists
    Michael A Gold, MD        

Pennsylvania

  • Philadelphia
    Fox Chase Cancer Center
    Christina Chu, MD    
  • Pittsburgh
    West Penn Hospital
    Eirwen Miller, MD      
  • Willow Grove
    Jefferson Health
    Mark S Shahin, MD        

Rhode Island

  • Providence, Rhode Island 02905 
    Women and Infants Hospital
    Cara Mathews, MD        

Tennessee

  • Knoxville
    University of Tennessee
    Jonathan Boone, MD        

Texas

  • Austin
    Michael J. Teneriello     
  • Dallas, Texas
    Carolyn Michelle Matthews    
  • Fort Worth
    Noelle Cloven, MD        

Virginia

  • Charlottesville
    Kari Ring, MD        
  • Roanoke, Virginia 24016
    David Iglesias, MD        

Washington

  • Seattle
    Fred Hutchinson Cancer Center
    Kathryn Pennington, MD
This Study is Open To:

This study is open to women age 18 years or older who meet the following criteria:

  • Recurrent or advanced endometrial cancer.
  • Primary Stage III or Stage IV cancer or first recurrence of endometrial cancer with a low potential for cure, and at least one of the following:
    • Primary Stage IIIA to IIIC1 measurable cancer.
    • Primary Stage IIIC1, Stage IIIC2 or Stage IV disease.
    • Has first recurrence and has not received systemic treatment.
    • Has received prior neo-adjuvant/adjuvant systemic anticancer therapy and had a recurrence or progression of disease (PD) >=6 months after completing treatment
This Study is Not Open To:

People with the following are not eligible for the study:

  • Have received neo-adjuvant/adjuvant systemic anticancer therapy for primary Stage III or IV disease and:
    • have not had a recurrence or disease progression OR
    • have had a recurrence or disease progression within 6 months of completing systemic anticancer therapy
  • Had >1 recurrence of endometrial cancer.
  • Have received prior therapy with an immune checkpoint inhibitor (anti-PD-1), anti-PD-ligand 1 (anti-PD-L1), or anti-PD-ligand 2 (anti-PD-L2) agent.
  • Have another cancer.
  • Have significant heart disease.