Lirilumab and Nivolumab With 5-Azacitidine in Patients With Myelodysplastic Syndromes (MDS)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02599649
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lirilumab — DRUG
    3 mg/kg by vein every 4 weeks.
  • Nivolumab — DRUG
    3 mg/kg by vein on Days 7 and 21 of a 28 day cycle.
  • Azacitidine — DRUG
    75 mg/m\^2 by vein for 7 days of a 28 day cycle.

Study Details

The goal of this clinical research study is to learn if lirilumab and Opdivo (nivolumab), alone or in combination with Vidaza (azacitidine), can help to control MDS. The safety of these drug combinations will also be studied. This is an investigational study. Lirilumab is not FDA approved or commercially available. It is currently being used for research purposes. Nivolumab is FDA approved and commercially available for the treatment of melanoma and non small cell lung cancer (NSCLC). Azacitidine is FDA approved and commercially available for the treatment of MDS. The study doctor can explain how the study drugs are designed to work. Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.

Key Dates

Start date
Mar 21, 2016
Status verified
Jan 2020
Primary completion
Jan 30, 2019
Completion
Jan 30, 2019

Study Design

Enrollment
10 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low or Intermediate-1 MDS Group - Lirilumab
    Lirilumab by vein over about 60 minutes 1 time each 28 day cycle.
  • Experimental: Low or Intermediate-1 MDS Group - Nivolumab + Lirilumab
    Nivolumab by vein over about 60 minutes every 2 weeks during Cycles 1-9. Lirilumab by vein over about 60 minutes 1 time each cycle. Cycle is 28 days.
  • Experimental: High Risk MDS Group - Azacitidine + Lirilumab
    Azacitidine by vein over about 60 minutes on Days 1-7 of each 28 day cycle. Lirilumab by vein over about 60 minutes on Day 7 of each 28 day cycle.
  • Experimental: High Risk MDS Group - Azacitidine + Lirilumab + Nivolumab
    Azacitidine by vein over about 60 minutes on Days 1-7 of each 28 day cycle. Lirilumab by vein over about 60 minutes on Day 7 of each 28 day cycle. On Days 7 and 21 of Cycles 1-9 and then on Day 7 of Cycles 10 and beyond, Nivolumab by vein over about 60 minutes.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: 116 days ]

Locations (1)

FacilityCityStateZIP
University of Texas MD Anderson Cancer CenterHoustonTexas77030

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