GOG-3053 (Endometrial Cancer) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn about the safety and effectiveness of the investigational drug, pembrolizumab, with chemotherapy with or without radiation therapy when given for newly-diagnosed high-risk endometrial cancer.

Pembrolizumab is the study drug that works to help your immune system fight cancer cells.

What is the Condition Being Studied?

Newly-diagnosed High-Risk Endometrial Cancer

Who Can Participate in the Study?

Adult women with newly diagnosed high-risk endometrial cancer

Age Group
Adults

What is Involved?

If you agree to be in this study, you will:
- Be randomized (a fair 50/50 chance), to Group A or Group B
--- Group A will get the study drug (pembrolizumab) and paclitaxel and carboplatin every 3 weeks followed by 6 doses of pembrolizumab every 6 weeks
--- Group B will get a placebo (harmless saltwater) and paclitaxel and carboplatin every 3 weeks followed by 6 doses of placebo every 6 weeks

Both groups will get 4-6 doses of chemotherapy (paclitaxel and carboplatin) with 6 doses of pembrolizumab or placebo followed by 6 doses of pembrolizumab or placebo depending on your group assignment.

Radiation therapy may be given during the study with decision by you and your study doctor.

Long term follow-up contact will be made every 6 months for the first 2 years and then every year, indefinitely

Study Details

Full Title
A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent
Principal Investigator
Gynecologic Oncologist
Protocol Number
IRB: PRO00107389
NCT: NCT04634877
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698