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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-05-14 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06253494
The ClinicalTrials.gov registry entry for NCT06253494 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 524-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (89% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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