Clinical Trial

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

Study acronym: DE-01

Recruiting Phase 3

Summary

DESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC.

Protocol Amendment History 12 amendments

This ClinicalTrials.gov record has been amended 12 times since 2025-05-15; most recent amendment 2026-06-19.

Trial Details

NCT Number	NCT06989112
Lead Sponsor	AstraZeneca Collaborators: Daiichi Sankyo Co., Ltd., GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)
Conditions	Endometrial Cancer
Enrollment	600 participants
Start Date	2025-03-27
Primary Completion	2029-01-19 (estimated)
Study Completion	2031-02-19 (estimated)
Updated on ClinicalTrials.gov	2026-08-11