Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing AdHER2DC vaccine for Endometrial Cancer

Background: Endometrial cancer (EC) of the uterus is becoming more common in the US. Sometimes EC often has increased levels of a protein called HER2.

Official registry: https://clinicaltrials.gov/study/NCT06253494 · National Cancer Institute (NCI) · enrollment listed as 60

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

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 AdHER2DC vaccine, Pembrolizumab, or N-803. The registry lists allocation as randomized. Background: Endometrial cancer (EC) of the uterus is becoming more common in the US.

They plan to enroll about 60 people at Bethesda. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, using or being fitted with a device plus check-ins.

Official title (unrewritten)

Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologous Dendritic Cell (AdHER2DC) Vaccine in Participants With Advanced or Metastatic Endometrial Cancer

Interventions: AdHER2DC vaccine, Pembrolizumab, N-803, Lenvatinib, PATHWAY HER2 (4B5) assay

Primary outcome (registry wording): Phase I: Estimate recommended RP2D of pembrolizumab, lenvatinib, N-803, and AdHER2DC vaccine in participants with HER2 positive endometrial cancer

Who it is for (from inclusion criteria)

  • Ages 18 Years to 120 Years
  • Histologically confirmed endometrial cancer
  • Radiographically confirmed metastatic or locally advanced disease
  • Evaluable (measurable or non-measurable) disease, per RECIST 1.1
  • HER2 IHC 1+, 2+ or 3+ tumor confirmed by PATHWAY HER2 (4B5) test. NOTE: The HER2 status in participants who had prior anti-HER2 therapy should be confirmed in the tumor tissue obtained after completing the anti-HER2 therapy
  • Participants must have received and progressed after at least one (1) line of systemic therapy for endometrial cancer
  • how well you can do daily activities (ECOG score) \<=2
  • Participants must have available tumor tissue or be willing to undergo a mandatory research biopsy. NOTE: Samples must be collected after HER2 directed therapy if the participant had anti-HER2 therapy

Public study contact (from the registry)

Megan P Hausler, R.N.

(240) 858-3544

megan.hausler@nih.gov

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

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT06253494 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 NCT06253494?

Phase 1 / Phase 2. 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 NCT06253494?

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