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RECRUITING
NCT04535713
PHASE2

GALLANT: Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab for Advanced Sarcoma

Sponsor: Sarcoma Oncology Research Center, LLC

View on ClinicalTrials.gov

Summary

This is an open label phase 2 study for advanced sarcoma using metronomic doses of gemcitabine, doxorubicin and docetaxel, and nivolumab immunotherapy given intravenously.

Official title: GALLANT: A Phase 2 Study Using Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab as Second/Third Line Therapy for Advanced Sarcoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2020-09-30

Completion Date

2025-12-31

Last Updated

2024-07-05

Healthy Volunteers

No

Conditions

Interventions

DRUG

Gemcitabine

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

DRUG

Doxorubicin

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

DRUG

Docetaxel

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

DRUG

Nivolumab

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

Locations (1)

Sant P Chawla

Santa Monica, California, United States