NRG-GY020 Newly Diagnosed Early Stage Endometrial Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if adding an immunotherapy drug called pembrolizumab (the study drug) to the usual radiation treatment for endometrial cancer can lower the chance that your cancer comes back.

What is the Condition Being Studied?

Early Stage High Intermediate Risk Endometrial Cancer

Who Can Participate in the Study?

Adults ages 18+ who:
- Are diagnosed with Stage I endometrioid endometrial and have certain age and risk factors; OR
- Are diagnosed with Stage II endometrioid endometrial cancer
- Have never received hormonal therapy, chemotherapy, immunotherapy, or radiation therapy for endometrial cancer
- Have undergone surgical staging with at least hysterectomy, removal of cervix, bilateral salpingo-oophorectomy, and either sentinel lymph node assessment or complete pelvic aortic lymphadenectomy

For more information about who can join this study, please contact the study team at nick.jeffries@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Be randomly assigned (like a coin flip) to 1 of 2 groups
-- Group 1 will get radiation for 2-6 weeks and visit our clinic every 12 weeks for a year after radiation is finished
-- Group 2 will get radiation for 2-6 weeks and get the study drug by infusion (IV) 6 weeks for up to one year

Study Details

Full Title
NRG-GY020: A Phase III Randomized Trial of Radiation +/- Pembrolizumab (MK-3475) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer
Principal Investigator
Gynecologic Oncologist
Protocol Number
IRB: PRO00109012
NCT: NCT04214067
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698