RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Trastuzumab deruxtecan for Endometrial Cancer

DESTINY-Endometrial01 will investigate the how well it works 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.

Official registry: https://clinicaltrials.gov/study/NCT06989112 · AstraZeneca · enrollment listed as 600

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Trastuzumab deruxtecan, Rilvegostomig, or Pembrolizumab. The registry lists allocation as randomized. DESTINY-Endometrial01 will investigate the how well it works 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.

They plan to enroll about 600 people at 230 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Trastuzumab deruxtecan, Rilvegostomig, Pembrolizumab, Carboplatin, Paclitaxel, Docetaxel

Primary outcome (registry wording): Progression-free survival (PFS), as assessed by BICR

Who it is for (from inclusion criteria)

Ages 18 Years to any
Women only
≥ 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)
Participant must have primary advanced disease (Stage III/IV) or 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 1.1 based on the investigator's assessment
Primary Stage IV (per FIGO 2023) disease regardless of presence of measurable disease at baseline
Recurrent disease regardless of presence of measurable disease at baseline
Endometrial cancer with HER2 IHC expression of 3+ or 2+ by prospective central testing

Who the registry excludes

Any severe or uncontrolled systemic diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or would jeopardize compliance with the protocol
Active or ongoing serious chronic gastrointestinal conditions associated with diarrhea, primary immunodeficiency, or non-infectious skin disease requiring systemic treatment
Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs
History of (non-infectious) ILD/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
Any autoimmune, connective tissue or inflammatory disorders where there is documented, or a suspicion of pulmonary involvement at the time of screening
Prior pneumonectomy (complete)
History of myocardial infarction or unstable angina within 6 months before randomization, or symptomatic congestive heart failure (NYHA Class II to IV), clinically significant arrhythmia, uncontrolled hypertension, cardiomyopathy of any etiology or history of myocarditis

Public study contact (from the registry)

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

230 listed

Research Site — Tucson, Arizona (withdrawn)
Research Site — Little Rock, Arkansas (recruiting)
Research Site — Duarte, California (recruiting)
Research Site — Irvine, California (recruiting)
Research Site — La Jolla, California (recruiting)
Research Site — Palo Alto, California (withdrawn)
Research Site — San Francisco, California (not_yet_recruiting)
Research Site — Sylmar, California (withdrawn)
Research Site — Fort Myers, Florida (recruiting)
Research Site — Miami, Florida (not_yet_recruiting)
Research Site — Miami Beach, Florida (recruiting)
Research Site — Orlando, Florida (not_yet_recruiting)

+ 171 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06989112 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06989112?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06989112?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary