NCT06989112

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab deruxtecan	Experimental therapy by intravenous infusion
DRUG	Rilvegostomig	Experimental therapy by intravenous infusion
DRUG	Pembrolizumab	Immunotherapy by intravenous infusion
DRUG	Carboplatin	Standard of Care (SoC) chemotherapy by intravenous infusion
DRUG	Paclitaxel	Standard of Care (SoC) chemotherapy by intravenous infusion
DRUG	Docetaxel	Standard of Care (SoC) chemotherapy by intravenous infusion

Timeline

• Start date: 2025-03-27
• Primary completion: 2029-01-19
• Completion: 2031-02-19
• First posted: 2025-05-25
• Last updated: 2026-04-08

Locations

249 sites across 23 countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study