A Phase 3 Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab Immunotherapy Versus Chemotherapy Plus Pembrolizumab as Initial Treatment for HER2-Expressing Mismatch Repair-Proficient Advanced Endometrial Cancer

Full Title

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 First-Line Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer (DESTINY-Endometrial01) (WCG IRB)

Purpose

Researchers are comparing 3 different combination treatments for endometrial cancer that came back after treatment or spread. The people in this study have endometrial cancer that expresses the HER2 protein and is mismatch repair proficient. Mismatch repair proficient means their cells can fix DNA errors.

If you take part in this study, you will be randomly assigned to receive one of these therapies:

  • Trastuzumab deruxtecan (T-DXd) plus rilvegostomig
  • T-DXd plus pembrolizumab immunotherapy
  • Chemotherapy (carboplatin and paclitaxel) plus pembrolizumab

Who Can Join

To join this study, there are a few conditions. You must:

  • Have stage 3, stage 4, or recurrent endometrial cancer that expresses HER2 and is mismatch repair proficient.
  • Not have received prior anti-cancer medication for advanced cancer, nor prior immunotherapy. You may have received neoadjuvant (presurgical) or adjuvant chemotherapy (after cancer surgery), given with the intent to cure, if your cancer came back 6 or more months after prior treatment.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information about this study or to see if you can join, please call Dr. Vicky Makker’s office at 646-888-4224.

Protocol

25-330

Phase

Phase III (phase 3)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06989112