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Eisai Merck KEYNOTE-775 (Advanced Endometrial Cancer) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn what effects the study drugs, lenvatinib plus pembrolizumab, have on advanced endometrial cancer, when compared to standard chemotherapy.

This study is also looking if it is safe to take the drugs lenvatinib plus pembrolizumab compared to treatment with standard chemotherapy using doxorubicin or paclitaxel.

What is the Condition Being Studied?

Advanced endometrial cancer

Who Can Participate in the Study?

Adult females with advanced endometrial cancer who have been treated with at least one prior chemotherapy regimen

Age Group
Adults

What is Involved?

If you choose to be in this study, you will:
- Be randomized (put into one of two groups by chance like a flip of a coin) to either:
--- Group 1: lenvatinib capsules and pembrolizumab infusion (study drugs)
--- Group 2: Get either doxorubicin or paclitaxel infusions
- Get study drugs every 3 weeks for 3 cycles
- Have follow-up visits every 8 weeks with CT/MRI scans
- Be in the study for up to 3 years and have 12 or more office visits to the clinic

Study Details

Full Title
A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination with Pembrolizumab Versus Treatment of Physician's Choice in Participants with Advanced Endometrial Cancer
Principal Investigator
Gynecologic Cancers Specialist
Protocol Number
IRB:PRO00100905
NCT:NCT03517449
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698