Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT06253494 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Endometrial Cancer and Endometrial Carcinoma, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 1
Development phase
60
Enrollment target
1
Study location

NCT06253494: Recruiting Phase 1 study of Endometrial Cancer and Endometrial Carcinoma, sponsored by National Cancer Institute (NCI).

NCT06253494 is a Phase 1 study of Endometrial Cancer and Endometrial Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 60 participants, below the 524-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT06253494, a Phase 1 study of Endometrial Cancer and Endometrial Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 1
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

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. Cancers with HER2 tend to be more aggressive and have poorer outcomes. Objective: To test 2 study drugs-a vaccine that targets HER2 (AdHER2DC) plus a drug that supercharges immune cells that kill tumor cells (N-803)-combined with 2 FDA-approved cancer treatment drugs in people with EC. Eligibility: Adults aged 18 and older with HER2-positive EC that returned or got worse after treatment. Design: AdHER2DC vaccine is made from each participant s own blood. Participants will undergo apheresis: Blood is removed from the body through a tube attached to a needle. The blood passes through a machine that separates out the target cells. The remaining blood is returned to the body through a second needle. A special catheter may be needed. The first treatment cycle is 28 days; each cycle after that will be 21 days. All participants will get the 2 approved drugs and the vaccine. One drug is a tablet taken by mouth once a day, every day. The other drug is given through a tube attached to a needle inserted into a vein. The vaccine is injected under the skin. Participants will receive the vaccine on day 1 of cycles 1, 2, and 3. Additional doses up to 3 doses will be give if possible. Some participants will receive N-803. This drug is injected under the skin of the abdomen on day 1 of each cycle. Treatment may last up to 1 year. Follow-up visits will continue up to 2 more years.

Primary Outcome

Number of Dose Limiting Toxicities (DLT).

Conditions Studied

Endometrial Cancer Endometrial Carcinoma Cancer of Endometrium Carcinoma of Endometrium

Interventions

  • BIOLOGICAL Pembrolizumab
  • DRUG Lenvatinib
  • BIOLOGICAL AdHER2DC vaccine
  • BIOLOGICAL N-803
  • DEVICE PATHWAY HER2 (4B5) assay

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2024-05-14
Est. Completion 2028-12-31
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What NCT06253494 shows while recruiting

NCT06253494 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 524-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (89% lower).

The record links to 4 conditions, with Endometrial Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT06253494 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT06253494 about?

NCT06253494 is a clinical study titled "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". 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. Cancers with HER2 tend to be more aggressive and have poorer outcomes. Objective: To test 2 study drugs-a vaccine that targets HER2 (AdHER2DC) plu...

What is the current status of trial NCT06253494?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2024-05-14. Estimated completion is 2028-12-31.

What conditions does trial NCT06253494 study?

This clinical trial studies the following conditions: Endometrial Cancer, Endometrial Carcinoma, Cancer of Endometrium, Carcinoma of Endometrium.

What interventions are being tested in trial NCT06253494?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Lenvatinib (DRUG), AdHER2DC vaccine (BIOLOGICAL), N-803 (BIOLOGICAL), PATHWAY HER2 (4B5) assay (DEVICE).

Who is sponsoring clinical trial NCT06253494?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06253494 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Endometrial Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06253494's enrollment target sits among peer trials

60 117th of 181 higher than 63 of 181 other Endometrial Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Endometrial Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00576069 · 60 participants

    Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma

  • NCT01297400 · 60 participants · Phase 2

    Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns

  • NCT01734122 · 60 participants

    Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor

  • NCT01804634 · 60 participants · Phase 2

    Reduced Intensity Haploidentical BMT for High Risk Solid Tumors

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

More recruiting context for NCT06253494

Source: ClinicalTrials.gov NCT06253494, the US trial registry maintained by the National Library of Medicine. NCT06253494 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.