Study on Adding a Personalized Vaccine to Durvalumab, Tremelimumab, and Chemotherapy for Metastatic Triple Negative Breast Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03606967

Provider View

This clinical trial is exploring whether adding a personalized vaccine to a combination of chemotherapy and immunotherapy drugs can improve treatment for patients with metastatic triple negative breast cancer. The study aims to see if this approach can better control the cancer compared to the standard treatment.

Patient Parameters

Program Overview

This phase II study is testing a new treatment approach for patients with metastatic triple negative breast cancer, which is a type of cancer that has spread from its original site to other parts of the body. The trial is investigating whether a combination of chemotherapy (nab-paclitaxel), immunotherapy drugs (durvalumab and tremelimumab), and a personalized vaccine can more effectively stop the growth and spread of cancer cells. The vaccine is designed to help the immune system recognize and attack the cancer cells. Researchers are comparing the effects of this combination with and without the vaccine to determine which is more effective.

Description

The main goal of this study is to evaluate how well the combination of nab-paclitaxel, durvalumab, tremelimumab, and a personalized vaccine works in treating metastatic triple negative breast cancer. The study will also assess the safety of these treatments and how they affect the immune system's response to the cancer.

Study Design:

  • Part A: Patients will receive chemotherapy drugs gemcitabine and carboplatin through an IV on specific days of each cycle, repeating every 21 days for up to 18 weeks. If the cancer progresses or the patient cannot tolerate the treatment, they may switch to nab-paclitaxel, which is given on different days and cycles.

  • Part B: Patients will be randomly assigned to one of two groups:

    • Group 1: Will receive the personalized vaccine along with tremelimumab, durvalumab, and nab-paclitaxel.
    • Group 2: Will receive tremelimumab, durvalumab, and nab-paclitaxel without the vaccine.

Both groups will receive their treatments in cycles, with regular monitoring for disease progression or side effects. Patients will also undergo tumor biopsies, blood tests, and imaging scans during the study.

After completing the study treatment, patients will have follow-up visits every three months for a year, then annually.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of metastatic triple negative breast cancer.
  • Cancer must be estrogen receptor (ER) and progesterone receptor (PR) negative, and HER2 negative.
  • Must not have received prior treatment for metastatic triple negative breast cancer.
  • Must be 18 years or older.
  • Must have a good performance status and a life expectancy of at least 12 weeks.
  • Must have adequate blood counts and organ function.
  • Women of childbearing potential must use effective contraception during the study and for 180 days after treatment.
  • Must be willing to comply with study procedures and follow-up visits.
  • HIV-positive patients are eligible if they have a stable condition and are on antiretroviral therapy.
  • Must be able to understand and sign an informed consent document.

Exclusion Criteria

  • Not eligible if unable to receive carboplatin and gemcitabine as first-line therapy.
  • Cannot have had recent chemotherapy, radiotherapy, or biologic therapy.
  • Cannot have received prior immunotherapy for metastatic disease.
  • Cannot have unresolved side effects from previous cancer treatments.
  • Cannot be on other investigational drugs or have received them recently.
  • Cannot have had major surgery recently.
  • Cannot have active central nervous system disease, except treated asymptomatic metastases.
  • Cannot have a history of severe allergic reactions to similar drugs or vaccines.
  • Cannot have uncontrolled illnesses or infections.
  • Pregnant or breastfeeding women are excluded.
  • Cannot have active autoimmune diseases requiring treatment in the past two years.
  • Cannot have a history of lung diseases like pneumonitis.
  • Cannot have active infections like tuberculosis or hepatitis.
  • Cannot have had another cancer unless disease-free for at least one year.

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