OncoMatch/Clinical Trials/NCT06253494
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
Is NCT06253494 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for endometrial cancer.
Treatment: AdHER2DC vaccine · Pembrolizumab · N-803 · Lenvatinib · PATHWAY HER2 (4B5) assay — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Endometrial Cancer
Biomarker criteria
Required: HER2 (ERBB2) IHC 1+, 2+ or 3+ overexpression (IHC 1+, 2+ or 3+)
HER2 IHC 1+, 2+ or 3+ tumor confirmed by PATHWAY HER2 (4B5) test
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — endometrial cancer
Participants must have received and progressed after at least one (1) line of systemic therapy for endometrial cancer.
Cannot have received: immune checkpoint inhibitor (anti-CTLA, anti-PD-1, anti-PD-L1, anti-TIGIT, anti-TIM3, anti-LAG3)
Administration of any standard of care or investigational checkpoint inhibitors (e.g., anti-CTLA, anti-PD-1, anti-PD-L1, anti-TIGIT, anti-TIM3, or anti-LAG3 antibodies or small molecules) within 6 months prior to apheresis.
Cannot have received: VEGFR inhibitor (lenvatinib)
History of Lenvatinib use
Lab requirements
Blood counts
ANC > 1,000/microliter; Platelets > 100,000/microliter; Hemoglobin > 9 g/dL (any number of transfusions within 60 days before apheresis is allowed)
Kidney function
Estimated creatinine clearance <=1.5 X ULN OR >30 mL/min/1.73 m2 for creatinine >1.5 X ULN
Liver function
Total bilirubin <=1.5 X ULN (<=3.0 X ULN with Gilbert's Syndrome or liver metastasis); AST/ALT <=3.0 X ULN (<=5.0 X ULN with liver metastasis)
Cardiac function
Fridericia's corrected QT interval (QTcF) < 480 msec; no evidence of third-degree AV block on ECG; ejection fraction by echocardiogram >= 50 percent; NYHA Functional Capacity III or IV or Objective Assessment C or D excluded
Participants must have adequate organ and marrow function as defined below: ... Fridericia's corrected QT interval (QTcF) >= 480 msec or evidence of third-degree AV block on screening electrocardiogram (ECG). Ejection fraction by screening echocardiogram < 50 percent. Functional or objective cardiac dysfunction: New York Heart Association (NYHA) Functional Capacity III or IV or Objective Assessment C or D.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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