Actively Recruiting
GALLANT: Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab for Advanced Sarcoma
Led by Sarcoma Oncology Research Center, LLC · Updated on 2024-07-05
260
Participants Needed
1
Research Sites
274 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open label phase 2 study for advanced sarcoma using metronomic doses of gemcitabine, doxorubicin and docetaxel, and nivolumab immunotherapy given intravenously.
CONDITIONS
Official Title
GALLANT: Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab for Advanced Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed diagnosis of locally advanced, unresectable or metastatic sarcoma
- Able to understand the study and provide written informed consent
- Willing to follow all study procedures and available for the study duration
- Previously treated with measurable disease by RECIST v1.1
- ECOG performance status of 2 or less
- Life expectancy of at least 3 months
- Acceptable heart function with left ventricular ejection fraction greater than 50%
- Acceptable liver function: bilirubin less than 1.5 times upper limit of normal (ULN), except Gilbert Syndrome patients who must have bilirubin less than 3.0 ULN; AST, ALT, and alkaline phosphatase less than 2.5 times ULN (less than 5 times ULN if liver metastases present)
- Acceptable kidney function: creatinine less than 1.5 times ULN and creatinine clearance over 60 ml/min
- Acceptable blood counts: absolute neutrophil count over 1000 cells/µL, platelet count over 100,000/µL, hemoglobin over 9.0 g/dL
- INR and PT less than 1.5 ULN unless on anticoagulants, in which case tests must be within therapeutic range
- Women of childbearing potential must have a negative pregnancy test within 72 hours before enrollment and agree to use effective contraception during and after the study (5 months for women, 7 months for men)
You will not qualify if you...
- History or evidence of active autoimmune disease requiring systemic treatment
- Currently receiving or recently (within 14 days) received another investigational drug or device
- Known allergy or sensitivity to gemcitabine, doxorubicin, docetaxel, or nivolumab
- Pregnant, breastfeeding, or planning pregnancy during treatment and for 3 months after last dose
- Women of childbearing potential unwilling to use effective contraception during treatment and for 3 months after last dose
- Sexually active participants and partners unwilling to use male or female latex condoms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sant P Chawla
Santa Monica, California, United States, 90403
Actively Recruiting
Research Team
S
Sant P Chawla, MD
CONTACT
V
Victoria Chua-Alcala
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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