drugset
drugset / Trial / NCT03259516

Nivolumab With Chemotherapy in Refractory MDS

NCT03259516 ↗

Phase 1/2 Terminated 2 enrolled St. Petersburg State Pavlov Medical University
Non-randomizedParallel-groupOpen-labelTreatment

Summary

There is evidence of involvement of checkpoint pathways, including PD-1, in the pathogenesis and resistance of myelodysplastic syndrome (MDS). However monotherapy with checkpoint inhibitors was ineffective in a number of studies, indicating the presence of several mechanisms of resistance. This pilot study evaluates the safety and preliminary efficacy of nivolumab combination with currently existing treatments in MDS patients who failed at least one line of therapy. The study evaluates if there is a combination which induces objective responses.

Timeline

Start
2017-05-25
Primary completion
2018-12-25
Completion
2018-12-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 75 mg/m2 Subcutaneous
Subject Cyclophosphamide Other / unclassified 300 mg/m2 Intravenous
Subject Cytarabine Small molecule 10 mg/m2 Subcutaneous
Subject Fludarabine Small molecule 25 mg/m2 Intravenous
Subject Melphalan Small molecule 2 mg Oral
Subject Nivolumab Monoclonal antibody 1 mg/kg Intravenous
Subject Sildenafil Unknown 20 mg Oral
Subject Tretinoin Small molecule 45 mg/m2 Oral

Indications

myelodysplastic syndrome