Study on Pembrolizumab, Lenvatinib, and IL-15 Superagonist N-803 with HER2 Targeting Vaccine for Advanced Endometrial Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06253494

Provider View

This clinical trial is testing a new combination of treatments, including a vaccine and immune-boosting drugs, to see if they can help control advanced endometrial cancer that has returned or worsened after treatment.

Patient Parameters

Program Overview

The study aims to test a new treatment approach for advanced endometrial cancer that involves a combination of a HER2-targeting vaccine, an immune-boosting drug (N-803), and two FDA-approved cancer drugs, pembrolizumab and lenvatinib. The goal is to see if this combination can effectively control cancer in patients whose disease has returned or progressed after previous treatments.

Description

Endometrial cancer is a common type of cancer affecting the uterus, and it can be more aggressive when it has high levels of a protein called HER2. This study is exploring a new treatment that combines a vaccine targeting HER2 with drugs that enhance the immune system's ability to fight cancer. The treatment includes:

  • A vaccine made from the patient's own blood cells, designed to target HER2-positive cancer cells.
  • Pembrolizumab and lenvatinib, two drugs already approved for treating certain types of cancer.
  • N-803, a drug that boosts immune cells to help them attack cancer cells.

Participants will undergo a procedure called apheresis to collect blood cells for the vaccine. The treatment cycles last 21 to 28 days, and participants will receive the vaccine and drugs over several cycles, potentially for up to a year. Follow-up visits will continue for up to two more years to monitor the treatment's effects and the patient's health.

The study is divided into two phases:

  • Phase I will determine the best dose of the treatment combination.
  • Phase II will assess how effective the treatment is in controlling cancer.

Participants must be adults with HER2-positive endometrial cancer that has returned or worsened after previous treatments. They must be in good overall health and willing to undergo the necessary procedures and follow-up visits.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with confirmed endometrial cancer.
  • Cancer that has spread or is locally advanced and confirmed to be HER2-positive.
  • Disease that has progressed after at least one previous treatment.
  • Good overall health with a performance status score of 0 to 2.
  • Willing to provide a tumor sample or undergo a biopsy.
  • Adequate blood cell counts and organ function.
  • Negative for active hepatitis B or C, or have these conditions under control.
  • Women of childbearing potential must agree to use effective contraception during and after the study.
  • Willing to sign informed consent and comply with study requirements.

Exclusion Criteria

  • Previous treatment with certain immune checkpoint inhibitors.
  • Severe allergic reactions to similar drugs.
  • Recent major surgery or other cancers diagnosed within the past two years.
  • Recent blood clots or strokes.
  • Significant heart problems or abnormal heart rhythms.
  • Need for blood thinners or anticoagulants.
  • History of severe bleeding or gastrointestinal issues.
  • Active autoimmune diseases requiring treatment.
  • Recent use of high-dose steroids.
  • HIV-positive status.
  • Pregnancy or breastfeeding.
  • Any condition that would interfere with the study.

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