GALLANT: Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumabfor Advanced Sarcoma
Trial ID: NCT04535713
Phase: Phase 2
Status: Recruiting
Last Update Posted: July 2024
Please Note: The estimated primary completion date for this trial was September 2025 and study completion December 2025. We recommend contacting the study team directly to confirm current recruitment status before pursuing enrollment.
Eligibility: Adults aged 18 and older with a confirmed diagnosis of locally advanced, unresectable or metastatic sarcoma who have previously received treatment and have measurable disease. Patients must have adequate cardiac, liver, renal, and blood count function and an ECOG performance status of 2 or below.
Overview: This Phase 2 trial tests a combination of three chemotherapy drugs, gemcitabine, doxorubicin, and docetaxel, given intravenously on Days 1 and 8 of each three-week cycle. After the first cycle, nivolumab (Opdivo), an immune checkpoint inhibitor, is added to the regimen. The goal is to evaluate whether this chemo-immunotherapy combination can slow or stop disease progression in patients with advanced sarcoma who have already received prior treatment. Patients may continue treatment for up to one year. Principal Investigator: Sant P. Chawla, MD, Sarcoma Oncology Research Center, LLC.
Preliminary Effectiveness: The primary goal of the study is to measure progression-free survival at 12 months. Secondary goals include overall response rate assessed at 6 weeks and incidence of treatment-related side effects over 12 months. No formal results have been posted to ClinicalTrials.gov at this time.

Study Contact:

Treatment Centers:

United States

  • Sarcoma Oncology Research Center, Santa Monica, CA

More Information: clinicaltrials.gov/study/NCT04535713