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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Gemcitabine

    Drug

    600 mg/m2 (Maximum Dose: 1000 mg) i.v. on Day 1 and Day 8 of Cycle 1+

  • Doxorubicin

    Drug

    18 mg/m2 (Maximum Dose: 32 mg) i.v. on Day 1 and Day 8 of Cycle 1+

  • Docetaxel

    Drug

    25 mg/m2 (Maximum Dose: 42 mg) i.v. on Day 1 and Day 8 of Cycle 1+

  • Nivolumab

    Drug

    240 mg i.v. on Day 1 beginnning Cycle 2+

Treatment groups

260 Participants
are divided into 1 treatment group
Group A: Single armExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Progression free survival

Progression free survival from start of treatment to disease progression or death from any cause

Time frame
12 months

Secondary outcomes

1

Overall response

Overall response by RECIST v1.1 via CT scan or MRI during the treatment period

Time frame
6 weeks
2

Adverse Events

Incidence of treatment related adverse events

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sarcoma Oncology Research Center, LLC

Lead sponsor

Source ClinicalTrials.gov
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