This Phase III research study is designed to discover whether the addition of pembrolizumab, a new immunotherapy drug, to the usual combination of chemotherapy drugs (paclitaxel and carboplatin) can lower the chance of your endometrial cancer growing or spreading. Because the study includes a placebo, patients will be randomly assigned to receive paclitaxel plus carboplatin plus pembrolizumab or paclitaxel plus carboplatin plus placebo. Pembrolizumab, is already approved by the FDA for use in several other types of cancer (e.g. melanoma, lung cancer, kidney cancer, bladdercancer, head and neck cancers and other cancers). This study, led by Dr. Joshua Cohen and associates from UCLA Department of Obstetrics and Gynecology, is intended to determine if the addition of pembrolizumab to the usual treatment for endometrial cancer could shrink or stabilize the cancer being treated.
Participants must meet the following criteria:
If you've answered yes to all of the above questions, please
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Patients will be stratified into 2 separate arms upon randomization:
Note: Everyone in the study will get paclitaxel and carboplatin with pembrolizumab or paclitaxel and carboplatin with a placebo for four and a half months, followed by pembrolizumab or a placebo for up to two years.
All participants enrolled in the study will undergo the following:
Once in the study, during the 1st visit, participants will be randomized (like drawing numbers from a hat) to one of the 2 treatment groups (paclitaxel and carboplatin + placebo or paclitaxel and carboplatin + pembrolizumab). As this is a placebo-controlled study, please note that you may receive inactive medications.
UCLA Protocol ID: IRB# 19-001886.
Please call (310) 794-9652 to learn more. In order to protect your privacy, please do not include any personal health information if you choose to e-mail us.