drugset / Trial / NCT04577014

Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma

NCT04577014

Non-randomizedSequentialOpen-labelTreatment

Summary

This study is being done to find out whether the study drug Retifanlimab, a monoclonal antibody against the PD-1 protein, combined with gemcitabine and docetaxel, is a safe and effective treatment for your disease. Gemcitabine and docetaxel are chemotherapy drugs that are commonly used to treat soft tissue sarcoma. Retifanlimab is an experimental drug that boosts the immune system's ability to fight cancer cells. The study researchers think that Retifanlimab may help gemcitabine and docetaxel work better against soft tissue sarcoma that is either locally advanced or has spread beyond its original location (metastasized), and it cannot be removed with surgery (unresectable).

Timeline

Start
2020-09-29
Primary completion
2026-09-29
Completion
2026-09-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 50 mg/m2
Subject Docetaxel Small molecule 60 mg/m2
Subject Docetaxel Small molecule 75 mg/m2
Subject Gemcitabine Small molecule 675 mg/m2
Subject Gemcitabine Small molecule 750 mg/m2
Subject Gemcitabine Small molecule 900 mg/m2
Subject Retifanlimab Monoclonal antibody 210 mg Intravenous
Subject Retifanlimab Monoclonal antibody 375 mg Intravenous

Indications