Trial Outcomes & Findings for Lirilumab and Nivolumab With 5-Azacitidine in Patients With Myelodysplastic Syndromes (MDS) (NCT NCT02599649)

Last Updated: 2020-01-14

Results Overview

Overall response rate (ORR) defined as complete response plus partial response (CR + PR) and hematological improvement (HI). MDS International Working Group criteria used to assess response.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

116 days

Results posted on

2020-01-14

Participant Flow

Recruitment Period: April 2016 to June 2017

Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.

Participant milestones

Participant milestones
Measure	Low or Intermediate-1 MDS Group - Lirilumab Lirilumab by vein over about 60 minutes 1 time each 28 day cycle. Lirilumab: 3 mg/kg by vein every 4 weeks.	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. Lirilumab: 3 mg/kg by vein every 4 weeks. Azacitidine: 75 mg/m\^2 by vein for 7 days of a 28 day cycle.
Overall Study STARTED	2	8
Overall Study COMPLETED	2	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low or Intermediate-1 MDS Group - Lirilumab n=2 Participants Lirilumab by vein over about 60 minutes 1 time each 28 day cycle. Lirilumab: 3 mg/kg by vein every 4 weeks.	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. Lirilumab: 3 mg/kg by vein every 4 weeks. Nivolumab: 3 mg/kg by vein on Days 7 and 21 of a 28 day cycle.	High Risk MDS Group - Azacitidine + Lirilumab n=8 Participants 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. Lirilumab: 3 mg/kg by vein every 4 weeks. Azacitidine: 75 mg/m\^2 by vein for 7 days of a 28 day cycle.	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. Lirilumab: 3 mg/kg by vein every 4 weeks. Nivolumab: 3 mg/kg by vein on Days 7 and 21 of a 28 day cycle. Azacitidine: 75 mg/m\^2 by vein for 7 days of a 28 day cycle.	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	—	3 Participants n=5 Participants	—	3 Participants n=21 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	—	5 Participants n=5 Participants	—	7 Participants n=21 Participants
Age, Continuous	74 years n=5 Participants	—	70 years n=5 Participants	—	71 years n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	—	2 Participants n=5 Participants	—	3 Participants n=21 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	6 Participants n=5 Participants	—	7 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	—	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	—	8 Participants n=5 Participants	—	10 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants	—	0 Participants n=21 Participants
Region of Enrollment United States	2 participants n=5 Participants	—	8 participants n=5 Participants	—	10 participants n=21 Participants

PRIMARY outcome

Timeframe: 116 days

Population: Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.

Overall response rate (ORR) defined as complete response plus partial response (CR + PR) and hematological improvement (HI). MDS International Working Group criteria used to assess response.

Outcome measures

Outcome measures
Measure	Low or Intermediate-1 MDS Group - Lirilumab n=2 Participants Lirilumab by vein over about 60 minutes 1 time each 28 day cycle. Lirilumab: 3 mg/kg by vein every 4 weeks.	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. Lirilumab: 3 mg/kg by vein every 4 weeks. Nivolumab: 3 mg/kg by vein on Days 7 and 21 of a 28 day cycle.	High Risk MDS Group - Azacitidine + Lirilumab n=8 Participants 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. Lirilumab: 3 mg/kg by vein every 4 weeks. Azacitidine: 75 mg/m\^2 by vein for 7 days of a 28 day cycle.	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. Lirilumab: 3 mg/kg by vein every 4 weeks. Nivolumab: 3 mg/kg by vein on Days 7 and 21 of a 28 day cycle. Azacitidine: 75 mg/m\^2 by vein for 7 days of a 28 day cycle.
Overall Response Rate (ORR)	1 Participants	—	6 Participants	—

Adverse Events

Low or Intermediate-1 MDS Group - Lirilumab

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Low or Intermediate-1 MDS Group - Nivolumab + Lirilumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High Risk MDS Group - Azacitidine + Lirilumab

Serious events: 7 serious events

Other events: 8 other events

Deaths: 0 deaths

High Risk MDS Group - Azacitidine + Lirilumab + Nivolumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Low or Intermediate-1 MDS Group - Lirilumab n=2 participants at risk Lirilumab by vein over about 60 minutes 1 time each 28 day cycle. Lirilumab: 3 mg/kg by vein every 4 weeks.	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. Lirilumab: 3 mg/kg by vein every 4 weeks. Nivolumab: 3 mg/kg by vein on Days 7 and 21 of a 28 day cycle.	High Risk MDS Group - Azacitidine + Lirilumab n=8 participants at risk 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. Lirilumab: 3 mg/kg by vein every 4 weeks. Azacitidine: 75 mg/m\^2 by vein for 7 days of a 28 day cycle.	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. Lirilumab: 3 mg/kg by vein every 4 weeks. Nivolumab: 3 mg/kg by vein on Days 7 and 21 of a 28 day cycle. Azacitidine: 75 mg/m\^2 by vein for 7 days of a 28 day cycle.
Blood and lymphatic system disorders Anemia	0.00% 0/2 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	12.5% 1/8 • Number of events 1 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.
Gastrointestinal disorders Colitis	50.0% 1/2 • Number of events 1 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	12.5% 1/8 • Number of events 1 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.
Infections and infestations Febrile Neutropenia	0.00% 0/2 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	50.0% 4/8 • Number of events 6 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.
General disorders Fever	0.00% 0/2 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	12.5% 1/8 • Number of events 1 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/2 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	12.5% 1/8 • Number of events 1 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.
Cardiac disorders Hypotension	0.00% 0/2 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	12.5% 1/8 • Number of events 1 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.
Infections and infestations Infections	100.0% 2/2 • Number of events 2 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	12.5% 1/8 • Number of events 1 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.
Nervous system disorders Intracranial Hemorrhage	0.00% 0/2 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	12.5% 1/8 • Number of events 1 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.
Infections and infestations Lung Infection	0.00% 0/2 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	12.5% 1/8 • Number of events 1 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.
Cardiac disorders Myocarditis	0.00% 0/2 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	12.5% 1/8 • Number of events 1 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.
Gastrointestinal disorders Small Intestine Obstruction	0.00% 0/2 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	12.5% 1/8 • Number of events 1 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.
Gastrointestinal disorders Gastric Hemorrhage	0.00% 0/2 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	12.5% 1/8 • Number of events 2 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.	— 0/0 • 2 years, 3 months Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.

Other adverse events

Additional Information

Guillermo Garcia-Manero, MD/Professor

The University of Texas MD Anderson Cancer Center

Phone: 713-745-3428

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place