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Nivolumab With Chemotherapy in Refractory MDS

NCT03259516 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-04-05

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • St. Petersburg State Pavlov Medical University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03259516 on ClinicalTrials.gov