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
AstraZeneca
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.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
* Key Inclusion Criteria: * Participants must be ≥ 18 years of age at the time of screening. Other age restrictions may apply as per local regulations. * Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies are allowed except for sarcomas (carcinosarcomas are allowed). * Following surgery or diagnostic biopsy, participant must have primary advanced disease (Stage III/IV) or first recurrent endometrial cancer and meet at least one of the following criteria: * Primary Stage III (per FIGO 2023) disease with measurable disease at baseline per RECIST 1…
Interventions
- DrugTrastuzumab deruxtecan
Experimental therapy by intravenous infusion
- DrugRilvegostomig
Experimental therapy by intravenous infusion
- DrugPembrolizumab
Immunotherapy by intravenous infusion
- DrugCarboplatin
Standard of Care (SoC) chemotherapy by intravenous infusion
- DrugPaclitaxel
Standard of Care (SoC) chemotherapy by intravenous infusion
- DrugDocetaxel
Standard of Care (SoC) chemotherapy by intravenous infusion
Locations (250)
- Research SiteTucson, Arizona
- Research SiteLittle Rock, Arkansas
- Research SiteDuarte, California
- Research SiteIrvine, California
- Research SiteLa Jolla, California
- Research SitePalo Alto, California