Phase III Study of Trastuzumab Deruxtecan with Rilvegostomig or Pembrolizumab Versus Chemotherapy Plus Pembrolizumab in Women with HER2-Positive, Mismatch Repair Proficient Advanced or Recurrent Endometrial Cancer

What this Trial Is About

Researchers are evaluating the effectiveness of trastuzumab deruxtecan T-DXd combined with either rilvegostomig or pembrolizumab compared to standard chemotherapy with carboplatin and paclitaxel plus pembrolizumab in treating women with HER2-expressing, mismatch repair proficient pMMR, advanced or recurrent endometrial cancer. This Phase III study focuses on progression-free survival PFS as the main measure of treatment success. Participants are randomly assigned to one of three groups Arm A receives T-DXd and rilvegostomig intravenously every three weeks Arm B receives T-DXd and pembrolizumab intravenously every three weeks Arm C receives carboplatin and paclitaxel intravenously every three weeks for six cycles plus pembrolizumab every three weeks, followed by pembrolizumab maintenance every six weeks for up to 20 total cycles or about 24 months. Docetaxel may replace paclitaxel if needed. Treatment continues until disease progression or other reasons to stop treatment. During the study, participants undergo regular assessments including imaging and laboratory tests to monitor disease status and treatment effects. Researchers will evaluate progression-free survival until disease progression or death, overall survival, response rates, safety, pharmacokinetics, and patient-reported tolerability over periods ranging up to approximately 70 months. Safety monitoring continues for 90 days after the last dose. The study aims to better understand treatment options for this type of endometrial cancer.

DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer