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Retifanlimab Alone or with Other Agents for Advanced Endometrial Cancer that Progressed with Platinum

Clinicaltrials.gov identifier:
NCT04463771

Treatment
Advanced endometrial cancer

Study Contact Information:

For additional information, please contact:

Incyte Corporation Call Center (US) by phone: 1.855.463.3463 or by email: [email protected]

Retifanlimab (Immunotherapy) Alone or Combined with Other Therapies for Advanced Endometrial Cancer that Progressed on or after Platinum Chemotherapy (POD1UM-204)

About the Study

This study is for people with advanced or endometrial cancer that has progressed on or after platinum-based chemotherapy. Participants will receive retifanlimab (a type of ) alone or in combination with other immunotherapies or targeted therapies.

Type of Study

This is an , study. Participants will be placed into one of five treatment groups. 

  • All people in the study will know which medication they are receiving.
  • Participants will be placed into a group based on tumor testing and previous treatments. 

What the Study Entails

There are five groups included in this study. People in all groups will receive retifanlimab through an intravenous injection (injected into their veins) on Day 1 of each 28-day cycle for up to 26 cycles.

  • Groups A and B: Patients in the study who have never received a type of treatment known as a  immune checkpoint inhibitor will be assigned to groups A or B based on their tumor type and markers. 
    • Group A will include people with a tumor known as MSI-H.
    • Group B will include people with a tumor known as OR people with turmor testing that shows many mutations in the POLE gene. 
  • Groups C and D: Patients who received immune checkpoint inhibitors in the past will be assigned to groups C or D, based on their tumor type and markers.
    • Group C will also receive oral epacadostat (IDO1 inhibitor) twice per day.
    • Group D will also receive oral pemigatininb (FGFR 1,2,3 inhibitor) once per day.
  • Group E: For patients who have not previously received  immune checkpoint inhibitors, who's tumor has these biomarkers: microsatellite stable (MSS) and positive. 
    • Group E will receive oral epacadostat twice per day.

Study participants will be followed for up to 4 years.

Study Sites

Alaska

  • Anchorage
    Alaska Womens Cancer Care Akwcc  

Arizona

  • Phoenix
    Arizona Oncology Associates - Biltmore Cancer Center
  • Tucson
    Arizona Oncology Associates

Florida

  • Fort lauderdale
    Broward Health Medical Center
  • Miami
    Miami Cancer Institute
  • Orlando         
    Advent Health Medical Group-Orlando
  • Tampa
    H. Lee Moffitt Cancer Center and Research Institute Hospital        

Georgia

  • Augusta
    Georgia Cancer Center          

Michigan

  • Detroit
    Barbara Ann Karmanos Cancer Hospital       

Minnesota

  • Minneapolis
    Minnesota Oncology - Maplewood  

Missouri

  • Saint Louis
    Washington University 

Montana

  • Billings
    Billings Clinic Cancer Center  

Nevada

  • Las Vegas
    Comprehensive Cancer Centers of Nevada  

New Mexico

  • Albuquerque
    New Mexico Cancer Care Alliance    

New York

  • New York City
    NYU Clinical Cancer Center    

North Carolina

  • Chapel Hill
    University of North Carolina At Chapel Hill  

Ohio

  • Hilliard
    The Ohio State University Wexner Medical Center Division of Gynecologic Oncology           

Oregon

  • Eugene
    Willamette Valley Cancer Institute   

South Dakota

  • Sioux Falls
    Texas Oncology - Tyler          

Tennessee

  • Nashville
    Tennessee Oncology 

Texas

  • Austin
    Texas Oncology-Austin Center
  • Fort Worth          
    Texas Oncology
  • San Antonio          
    Texas Oncology San Antonio
  • Shenandoah
    Texas Oncology the Woodlands       

Virginia

  • Richmond
    Virginia Commonwealth University  

The study is also open in the following countries:

  • Belgium
  • France
  • Germany
  • Greece
  • Italy

See the Clinicaltrials.gov listing or contact the sponsors by phone at: +800 00027423 or by email: [email protected] for additional information on study sites in Europe. 

This Study is Open To:

Women age 18 years or older who meet the following criteria:

  • Have advanced or endometrial cancer with disease progression on or after treatment with at least one platinum-based chemotherapy.
  • Groups A, B, and E: Have not been previously treated with a immune checkpoint inhibitor.
  • Group A only: Has tumor tissue tested as
  • Group B only: Has tumor tissue tested as or an ultra-mutated POLE (gene) tumor.
  • Group D only: Has tumor tissue tested as having an FGFR 1,2,3 mutation or alteration defined as per protocol.
  • Group E: Has tumor tissue tested as microsatellite stable (MSS) and positive.
  • Is willing to provide tumor tissue sample (fresh or archived).
This Study is Not Open To:

People with the following are not eligibe for the study:

  • Patients diagnosed with a type of cancer called sarcoma of the uterus are not eligible for the study. 
  • For Groups A, B and E only: Patients diagnosed with a type of cancer called carcinosarcoma (these patients may qualify for Groups C or D).
  • Are receiving chronic systemic steroids (> 10 mg/day of prednisone or equivalent)
  • Have hepatitis B or C
  • Are HIV-positive