OncoMatch/Clinical Trials/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
Is NCT06989112 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments for endometrial cancer.
Treatment: Trastuzumab deruxtecan · Rilvegostomig · Pembrolizumab · Carboplatin · Paclitaxel · Docetaxel — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Cancer type
Endometrial Cancer
Biomarker criteria
Required: HER2 (ERBB2) expression (IHC 3+ or 2+)
Endometrial cancer with HER2 IHC expression of 3+ or 2+ by prospective central testing
Required: Mismatch-repair proficient (pMMR / MSS)
Endometrial cancer that is determined pMMR by prospective central testing
Disease stage
Required: Stage III, IV (other)
Primary advanced disease (Stage III/IV) or recurrent endometrial cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: chemotherapy for endometrial cancer
Exception: one prior line of adjuvant/neoadjuvant chemotherapy with curative intent if completed ≥ 6 months prior to signature of the main ICF; prior trastuzumab in adjuvant/neoadjuvant setting is allowed
No prior chemotherapy for the treatment of EC, except for one prior line of adjuvant/neoadjuvant chemotherapy with curative intent (chemotherapy or chemoradiation) if completed ≥ 6 months prior to signature of the main ICF. Prior trastuzumab in the adjuvant/neoadjuvant setting is allowed.
Cannot have received: antibody-drug conjugate
No prior exposure to antibody-drug conjugates
Cannot have received: immune checkpoint inhibitor
No prior exposure to immune checkpoint inhibitors
Lab requirements
Blood counts
Adequate organ and bone marrow function within 14 days before randomization
Kidney function
Adequate organ and bone marrow function within 14 days before randomization
Liver function
Adequate organ and bone marrow function within 14 days before randomization
Cardiac function
Left ventricular ejection fraction ≥ 50% within 28 days before randomization
Left ventricular ejection fraction ≥ 50% within 28 days before randomization. Adequate organ and bone marrow function within 14 days before randomization.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Site · Tucson, Arizona
- Research Site · Little Rock, Arkansas
- Research Site · Duarte, California
- Research Site · Irvine, California
- Research Site · La Jolla, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06989112 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy for endometrial cancer, antibody-drug conjugate, immune checkpoint inhibitor disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 expression is a required biomarker for enrollment.
Does this trial require MLH1?
Yes, MLH1 wild-type is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify