Actively Recruiting
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
Led by National Cancer Institute (NCI) · Updated on 2026-04-09
60
Participants Needed
1
Research Sites
241 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed endometrial cancer
- Radiographically confirmed metastatic or locally advanced disease
- Evaluable disease according to RECIST 1.1 criteria
- HER2 IHC 1+, 2+, or 3+ tumor confirmed by PATHWAY HER2 (4B5) test
- Progressed after at least one line of systemic therapy for endometrial cancer
- Age 18 years or older
- ECOG performance status of 2 or less
- Available tumor tissue or willingness to undergo mandatory research biopsy
- Adequate organ and marrow function, including ANC > 1000/microliter, platelets > 100,000/microliter, hemoglobin > 9 g/dL, total bilirubin ≤ 1.5 times upper limit of normal (ULN) or ≤ 3.0 times ULN in specific cases
- AST/ALT ≤ 3.0 times ULN or ≤ 5.0 times ULN in cases with liver metastasis
- Estimated creatinine clearance > 30 mL/min/1.73 m2 or ≤ 1.5 times ULN
- Dip stick urine protein < 3 or urine protein < 1 gram/24 hour if dip stick urine ≥ 3+
- Hepatitis B virus (HBV) with undetectable DNA or Hepatitis C virus (HCV) with undetectable RNA
- Previously treated non-active brain or central nervous system metastases more than 28 days after radiotherapy or surgery
- Agreement to use highly effective contraception if of child-bearing potential
- Willingness to discontinue nursing during treatment and for 6 months after last dose
- Ability to understand and sign informed consent
You will not qualify if you...
- Use of checkpoint inhibitors within 6 months before apheresis
- History of grade 3 or 4 immune-related adverse events from checkpoint inhibitors
- Previous use of lenvatinib
- Severe immediate hypersensitivity to study drugs or components
- Surgery to abdomen, pelvis, or chest within 3 months before apheresis
- Other malignancies diagnosed within 24 months before apheresis except treated in-situ carcinomas or certain skin cancers
- Arterial or venous thromboembolism within 6 months before apheresis
- Stroke or cerebrovascular accident within 6 months before apheresis
- Severe cardiac dysfunction (NYHA III or IV) or low ejection fraction (<50%)
- Corrected QT interval ≥ 480 msec or third-degree AV block on ECG
- Requirement for therapeutic anticoagulation
- History of grade 3 or higher gastrointestinal or non-gastrointestinal fistula
- Major blood vessel invasion or infiltration
- Recent hemoptysis or tumor bleeding within 1 month before apheresis
- Conditions affecting absorption of lenvatinib
- Primary immunodeficiency
- Active or history of autoimmune disease requiring systemic immunosuppression
- Systemic corticosteroid therapy above physiologic dose within 14 days before apheresis
- Solid organ or allogeneic hematopoietic stem cell transplant recipients
- HIV positive status
- Pregnancy
- Uncontrolled illness or conditions limiting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
M
Megan P Hausler, R.N.
CONTACT
H
Hoyoung M Maeng, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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