GALLANT: Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab for Advanced Sarcoma
ConditionSarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSarcoma Oncology Research Center, LLC
About this trial
This is an open label phase 2 study for advanced sarcoma using metronomic doses of gemcitabine, doxorubicin and docetaxel, and nivolumab immunotherapy given intravenously.
Eligibility criteria
Qualifiers
Pathologically confirmed diagnosis of locally advanced, unresectable or metastatic sarcoma
Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the Investigator's IRB/Ethics Committee
Willingness to comply with all study procedures and availability for the duration of the study.
Previously treated patient with measurable disease by RECIST v1.1
Disqualifiers
History or evidence of active autoimmune disease that requires systemic treatment (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Currently receiving treatment with another investigational device or drug study, or <14 days since ending treatment with another investigational device or drug study(s).
Subject has known sensitivity to gemcitabine, doxorubicin, docetaxel or nivolumab.
Female subject is pregnant or breast-feeding or planning to become pregnant during study treatment and through 3 months after the last dose of gemcitabine, doxorubicin, docetaxel or nivolumab.
Trial design
Treatments tested in this trial
- Gemcitabine
- Doxorubicin
- Docetaxel
- Nivolumab
Treatment groups
260 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov