Retifanlimab (Immunotherapy) Alone or Combined with Other Therapies for Advanced Endometrial Cancer that Progressed on or after Platinum Chemotherapy (POD1UM-204)
https://www.facingourrisk.org/research-clinical-trials/study/165/retifanlimab-alone-or-with-other-agents-for-advanced-endometrial-cancer-that-progressed-with-platinum
Clinicaltrials.gov identifier:
NCT04463771 (https://clinicaltrials.gov/show/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]
About the Study
This study is for people with advanced or metastatic endometrial cancer that has progressed on or after platinum-based chemotherapy. Participants will receive retifanlimab (a type of immunotherapy) alone or in combination with other immunotherapies or targeted therapies.
Type of Study
This is an open-label, non-randomized 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 PD-L1 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 biomarker known as MSI-H.
- Group B will include people with a tumor biomarker known as dMMR OR people with turmor testing that shows many mutations in the POLE gene.
- Groups C and D: Patients who received PD-L1 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 PD-L1 immune checkpoint inhibitors, who's tumor has these biomarkers: microsatellite stable (MSS) and PD-L1 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 metastatic 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 PD-L1 immune checkpoint inhibitor.
- Group A only: Has tumor tissue tested as MSI-High
- Group B only: Has tumor tissue tested as dMMR 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 PD-L1 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
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.