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Cancer Vaccine

Combination Therapy for Endometrial Cancer

Phase 1 & 2

Waitlist Available

Led By Hoyoung M Maeng, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >=18 years

Histologically confirmed endometrial cancer

Must not have

Prior 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)

Functional or objective cardiac dysfunction: New York Heart Association (NYHA) Functional Capacity III or IV or Objective Assessment C or D

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing two study drugs in combination with two FDA-approved cancer treatment drugs to treat endometrial cancer in adults over 18 with a specific protein (HER2) in their cancer cells.

Who is the study for?

Adults aged 18+ with HER2-positive endometrial cancer that has returned or worsened after treatment. Participants must undergo apheresis to create the AdHER2DC vaccine from their own blood and may need a special catheter for this process.

What is being tested?

The trial is testing a combination of two FDA-approved drugs (one pill daily, one IV) and an experimental HER2-targeting vaccine made from participants' blood, with some also receiving N-803 to boost immune cells. Treatments last up to a year with follow-up visits for two more years.

What are the potential side effects?

Potential side effects include reactions at injection sites, possible organ inflammation due to immune response, fatigue, digestive issues related to oral medication, and general risks associated with intravenous drug administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer diagnosis was confirmed through tissue examination.

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My kidney function, measured by creatinine clearance, is within the required range.

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My cancer has spread beyond its original location.

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My endometrial cancer has worsened after at least one treatment.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not received any standard or experimental immune checkpoint inhibitors.

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My heart condition severely limits my daily activities.

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I am on blood thinners for my health condition.

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I have had a severe fistula.

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I do not have any stomach or intestine problems that affect how my body absorbs medicine.

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I have received a solid organ or bone marrow transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase I: Estimate recommended RP2D of pembrolizumab, lenvatinib, N-803, and AdHER2DC vaccine in participants with HER2 positive endometrial cancer

Phase II: Preliminarily assess the efficacy of a combination of pembrolizumab, lenvatinib, N-803, and AdHER2DC vaccine in participants with HER2 positive endometrial cancer

Secondary study objectives

Determine the safety of the combination of pembrolizumab, lenvatinib, N-803, and AdHER2DC vaccine in participants with HER2 positive endometrial cancer