Phase 3Recruiting
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 (DE-01)
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
- Sponsor
- AstraZeneca (Industry)
- Enrolment
- 600 planned
- Conditions
- Endometrial Cancer
- Interventions
- Trastuzumab deruxtecan; Rilvegostomig; Pembrolizumab; Carboplatin; Paclitaxel; Docetaxel
- Ages
- adults, older adults
- Registry
- NCT06989112, CTIS2023-508056-19-00
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Progression-free survival (PFS), as assessed by BICR
History
Study completion expected
Primary completion expected
Last registry update
Registered
Started