drugset / Trial / 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
Phase 3
Recruiting
600 enrolled
AstraZeneca
Daiichi Sankyo · collabEuropean Network of Gynaecological Oncological Trial Groups (ENGOT) · collabGOG Foundation · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-03-27
- Primary completion
- 2029-01-19
- Completion
- 2031-02-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | — | Intravenous |
| Comparator | Paclitaxel | Small molecule | — | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | — | Intravenous |
| Subject | Rilvegostomig | Other / unclassified | — | Intravenous |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | — | Intravenous |
| Comparator | Docetaxel | Small molecule | — | Intravenous |