Clinical Trials | An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as FirstLine Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer
DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as FirstLine Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer
The University of Virginia seeks adult women ages 18 years and older who have primary advanced or recurrent endometrial cancer. The goal of this study is to test if a cancer treatment called Trastuzumab Deruxtecan (T-DXd) in combination with other cancer treatments helps with cancer progression. If you decide to participate in this study, you will be randomized (assigned by chance) to one of three arms: Arm A: You will receive T-DXd intravenously (IV) plus Rilvegostomig intravenously (IV) Arm B: You will receive T-DXd (IV) plus pembrolizumab IV Arm C: You will receive Carboplatin, paclitaxel, and pembrolizumab IV followed by treatment with pembrolizumab You may be eligible for this study if: - Your cancer is stage III or IV - You have a histologically confirmed diagnosis of epithelial endometrial carcinoma - You have pMMR endometrial cancer with HER2 IHC expression of 3+ or 2+ This study involves blood sampling, physical examination, imaging of the chest, abdomen and pelvis, an echocardiogram (ECHO), and an electrocardiogram (ECG). This study will also require a take home Pulse Oximeter and an ePRO (electronic device like a mobile phone) to answer questionnaires about how you are feeling (provided to you at no cost). Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance. More information can be found here: https://clinicaltrials.gov/study/NCT06989112