Study on a Cancer Vaccine (STEMVAC) with Chemotherapy for Treating PD-L1 Negative Metastatic Triple-Negative Breast Cancer

Sponsor: University of Washington

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07078604

Provider View

This clinical trial is testing a new cancer vaccine called STEMVAC, combined with chemotherapy, to treat patients with PD-L1 negative, triple-negative breast cancer that has spread to other parts of the body. The vaccine aims to boost the immune system to target and destroy cancer cells.

Patient Parameters

Program Overview

This study is exploring how well a cancer vaccine named STEMVAC works when used with chemotherapy in patients with PD-L1 negative, triple-negative breast cancer that has spread beyond its original site. STEMVAC is designed to target proteins on breast cancer stem cells, helping the immune system recognize and attack the cancer cells. The chemotherapy options include drugs like Paclitaxel, Docetaxel, Cisplatin, Carboplatin, Doxorubicin, Liposomal Doxorubicin, and Eribulin, which work by stopping cancer cells from growing and dividing. The combination of STEMVAC and chemotherapy may offer an effective treatment for this type of breast cancer.

Description

In this study, patients will receive one of several chemotherapy regimens, chosen by their doctor, as long as the cancer does not progress or cause unacceptable side effects. Options include Paclitaxel, Docetaxel, Carboplatin, Cisplatin, Doxorubicin, Liposomal Doxorubicin, or Eribulin, given in specific cycles. Alongside chemotherapy, patients will receive STEMVAC vaccine doses with sargramostim, a substance that helps stimulate the immune system. The vaccine is given in three initial doses, followed by booster doses at specific intervals, unless the cancer progresses or side effects become too severe. Patients will also undergo CT or PET scans, blood tests, and possibly biopsies to monitor the treatment's effects. After completing the study treatment, patients will have follow-up visits every 6 months for 3 years to check on their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have confirmed triple-negative breast cancer, with specific hormone receptor and HER2 status.
  • Cancer must be PD-L1 negative.
  • Have metastatic cancer that can be measured by scans.
  • Have at least one site of cancer that can be biopsied during treatment.
  • Not have received prior cancer immunotherapy for metastatic cancer.
  • Be suitable for standard chemotherapy as determined by the doctor.
  • Have had at least 14 days since the last cancer treatment or radiotherapy.
  • Be willing to undergo up to two biopsies during the study.
  • Meet specific blood count and organ function requirements.
  • Women of childbearing potential must use effective contraception and have a negative pregnancy test before starting treatment.

Exclusion Criteria

  • Have received more than one prior treatment for metastatic cancer.
  • Have PD-L1 positive tumors.
  • Be enrolled in another interventional clinical trial.
  • Have certain heart conditions or autoimmune diseases requiring chronic steroids.
  • Have allergies to the study vaccine components.
  • Have had another cancer requiring treatment in the last 5 years.
  • Be pregnant or breastfeeding.
  • Have a history of HIV, hepatitis B, or hepatitis C.
  • Have had major surgery within 4 weeks before starting the study vaccine.
  • Have received a non-study vaccine within 14 days of the study vaccine, except for tetanus and diphtheria vaccines.

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