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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

NCT06989112 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-05-06

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Daiichi Sankyo Co., Ltd.

    collaborator INDUSTRY

  • GOG Foundation

    collaborator NETWORK

  • European Network for Gynaecological Oncological Trial groups(ENGOT)

    collaborator UNKNOWN

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-27
Primary Completion
2029-01-19
Completion
2031-02-19
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06989112 on ClinicalTrials.gov