NCT03259516

Nivolumab With Chemotherapy in Refractory MDS

Pilot Open-label Trial of Nivolumab Combined With Chemotherapy in Refractory Myelodysplastic Syndromes.

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: St. Petersburg State Pavlov Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Nivolumab	1 mg/kg by vein on Days 1 and 15 of a 28 day cycle
DRUG	Azacitidine	75 mg/m2 subcutaneously on Days 1-7 of a 28 day cycle
DRUG	Fludarabine	25 mg/m2 by vein on Days 1, 2 and 3 of a 28 day cycle. Dose reduction to 15 mg/m2 is permitted in cases of grade 4 hematological toxicity after first cycle.
DRUG	Cyclophosphamide	300 mg/m2 by vein on Days 1, 2 and 3 of a 28 day cycle.
DRUG	Cytarabine	10 mg/m2 subcutaneously two times a day on Days 1-10 of a 28 day cycle
DRUG	all trans retinoic acid	45 mg/m2 per os daily during the whole course of treatment
DRUG	Sildenafil	20 mg per os three times a day during the whole course of treatment
DRUG	Melphalan	2 mg per os daily during the whole course of treatment

Timeline

• Start date: 2017-05-25
• Primary completion: 2018-12-25
• Completion: 2018-12-25
• First posted: 2017-08-23
• Last updated: 2019-04-05

Locations

1 site across 1 country: Russia