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Retifanlimab Alone or with Other Agents for Advanced Endometrial Cancer that Progressed with Platinum
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.
Alaska Womens Cancer Care Akwcc
Arizona Oncology Associates - Biltmore Cancer Center
Arizona Oncology Associates
- Fort lauderdale
Broward Health Medical Center
Miami Cancer Institute
Advent Health Medical Group-Orlando
H. Lee Moffitt Cancer Center and Research Institute Hospital
Georgia Cancer Center
Barbara Ann Karmanos Cancer Hospital
Minnesota Oncology - Maplewood
- Saint Louis
Billings Clinic Cancer Center
- Las Vegas
Comprehensive Cancer Centers of Nevada
New Mexico Cancer Care Alliance
- New York City
NYU Clinical Cancer Center
- Chapel Hill
University of North Carolina At Chapel Hill
The Ohio State University Wexner Medical Center Division of Gynecologic Oncology
Willamette Valley Cancer Institute
- Sioux Falls
Texas Oncology - Tyler
Texas Oncology-Austin Center
- Fort Worth
- San Antonio
Texas Oncology San Antonio
Texas Oncology the Woodlands
Virginia Commonwealth University
The study is also open in the following countries:
See the Clinicaltrials.gov listing or contact the sponsors by phone at: +800 00027423 or by email: email@example.com for additional information on study sites in Europe.
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).
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