GALLANT: Study on Gemcitabine, Doxorubicin, Docetaxel, and Nivolumab for Advanced Sarcoma

Sponsor: Sarcoma Oncology Research Center, LLC

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04535713

Provider View

This clinical trial is testing a combination of chemotherapy and immunotherapy drugs to treat advanced sarcoma. The study aims to find out if this treatment can help control the disease in patients whose cancer cannot be removed by surgery or has spread.

Patient Parameters

Program Overview

This study is exploring a treatment for advanced sarcoma using a combination of chemotherapy drugs (gemcitabine, doxorubicin, and docetaxel) and an immunotherapy drug (nivolumab). The treatment is given through an IV and aims to see if it can help manage the cancer. The study will include 260 patients who will receive these medications in cycles every three weeks. Nivolumab will be added after the first cycle. Patients can continue the treatment for up to a year unless the cancer worsens or side effects become too severe.

Description

This clinical trial is testing a new treatment for advanced sarcoma, a type of cancer that affects the body's connective tissues. The treatment involves a combination of chemotherapy drugs—gemcitabine, doxorubicin, and docetaxel—given in metronomic doses, meaning they are administered in smaller, more frequent doses. Additionally, the immunotherapy drug nivolumab is included to help the immune system fight the cancer.

The study will involve 260 patients who will receive these drugs through an IV on specific days of a three-week cycle. After the first cycle, nivolumab will be added to the treatment plan. Patients can continue receiving the treatment for up to one year, as long as it is effective and side effects are manageable.

The goal is to determine if this combination can help control the cancer in patients whose sarcoma cannot be surgically removed or has spread to other parts of the body. The study will monitor the patients' response to the treatment and any side effects they experience.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced sarcoma that cannot be removed by surgery or has spread.
  • Understand the study's purpose and risks and have signed a consent form.
  • Willing to follow all study procedures and be available for the study's duration.
  • Have previously received treatment and have measurable cancer.
  • Be in good overall health with a performance status score of 2 or less.
  • Have a life expectancy of at least 3 months.
  • Have acceptable heart function with a left ventricular ejection fraction over 50%.
  • Have acceptable liver function with specific blood test results.
  • Have acceptable kidney function with specific blood test results.
  • Have adequate blood cell counts, including neutrophils, platelets, and hemoglobin.
  • Have normal blood clotting times unless on anticoagulants.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.

Exclusion Criteria

  • Have an active autoimmune disease requiring systemic treatment.
  • Currently participating in another drug study or recently finished one.
  • Have known allergies to any of the study drugs.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study and for a period after.
  • Are unwilling to use effective contraception during and after the study.
  • Are unwilling to use condoms during sexual activity.

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