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KEYNOTE890 Trial

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Phase: Phase II; Phase II trials look at how safe and effective a new treatment is. If a certain percentage of the participants benefit from the treatment and the side effects are acceptable, the new treatment will probably go on to a phase III trial. Phase II trials usually involve 25 to 100 people. The KEYNOTE890 trial wants to enroll 40 people.

ClinicalTrials.gov ID number: NCT03567720

Sponsor of the trial: OncoSec Medical Incorporated

Who is the trial for?

The KEYNOTE890 trial is currently enrolling adults diagnosed with metastatic or inoperable locally-advanced triple-negative breast cancer that hasn’t been treated yet.

Triple-negative breast cancer is cancer that is estrogen-receptor-negative, progesterone-receptor-negative, and HER2-negative. Locally-advanced breast cancer is breast cancer that has spread to tissue near the breast, such as the chest wall. Metastatic breast cancer is cancer that has spread to parts of the body away from the breast, such as the bones or liver. Both locally-advanced and metastatic breast cancer are considered advanced-stage disease. Inoperable means the cancer can’t be removed with surgery.

The trial wants to see how safe and effective the experimental immunotherapy TAVO is, when used in combination with Keytruda (chemical name: pembrolizumab), another immunotherapy medicine, with the chemotherapy medicine Abraxane (chemical name: albumin-bound or nab-paclitaxel), as a first treatment for metastatic or inoperable locally-advanced triple-negative breast cancer.

Why the trial is being done

TAVO, which stands for tavokinogene telseplasmid, is an immunotherapy medicine injected directly into the breast cancer tumor. A low electric current is applied to the tumor right after the injection, which allows TAVO to easily get into the cancer cells. Once in the cancer cells, TAVO makes the cells produce a specific protein called IL-12, which signals the body’s immune system to attack the cancer cells.

In earlier studies, TAVO was shown to increase the number of tumor-infiltrating lymphocytes (TILs) in a cancer tumor. TILs are white blood cells — immune system cells — that have left the bloodstream and moved into a cancer tumor. Researchers think that a cancer with high levels of TILs may be more responsive to certain immunotherapy medicines, such as Keytruda.

Both TAVO and Keytruda are immunotherapy medicines, but they work in different ways. Together, they may be more effective than either medicine is alone.

The KEYNOTE890 study is looking to see how effectively the combination of TAVO and Keytruda can treat advanced-stage triple-negative breast cancer, and whether the chemotherapy medicine Abraxane improves the effectiveness of the treatment. The study is also looking at the side effects caused by the treatments and how severe they are.

TAVO is given as an injection directly into a breast cancer tumor, followed by a low electric current that lasts less than 3 seconds. For the KEYNOTE890 trial, as many cancer tumors may be treated with TAVO as your doctor says is feasible.

Keytruda and Abraxane are given intravenously, which means they’re delivered directly into your bloodstream through an IV or a port.

In the study, people will receive:

  • TAVO every 6 weeks, on days 1, 5, and 8
  • Keytruda as a 30-minute infusion every 3 weeks, on day 1
  • Abraxane as a 30-minute infusion every 4 weeks, on days 1, 8, and 15

Specific eligibility requirements

People are eligible for the KEYNOTE890 trial if they:

  • have been diagnosed with metastatic or inoperable locally-advanced triple-negative breast cancer that has not been treated yet

People are not eligible for the KEYNOTE890 trials if they:

  • have been diagnosed with another cancer that is growing or requires treatment
  • have growing breast cancer lesions in the brain or spinal cord
  • have an electronic pacemaker or defibrillator
  • have a history of HIV
  • are positive for hepatitis B or hepatitis C
  • have a history of lung disease that has caused scarring of the lungs

Potential side effects of the treatments being studied

In earlier studies, the most common side effects of TAVO were:

Side effects caused by Keytruda include:

Side effects caused by Abraxane include:

Study locations

The KEYNOTE890 study is being conducted at various sites in the United States and Australia. For a complete list of sites, visit https://clinicaltrials.gov/ct2/show/NCT03567720

For more information or to enroll

Visit the KEYNOTE890 website or email kirvine@oncosec.com.


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