Trial · NCT02599649
Lirilumab and Nivolumab With 5-Azacitidine in Patients With Myelodysplastic Syndromes (MDS)
NCT02599649, Phase 2, Terminated, M.D. Anderson Cancer Center; results first posted 2020-01-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lirilumab and Nivolumab With 5-Azacitidine in Patients With Myelodysplastic Syndromes (MDS). Trials, record NCT02599649. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02599649
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lirilumab and Nivolumab With 5-Azacitidine in Patients With Myelodysplastic Syndromes (MDS)
- NCT number
- NCT02599649
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Leukemia
- Interventions
- Lirilumab, Nivolumab, Azacitidine
- First posted
- 2015-11-06
- Last updated
- 2020-01-14
- Results first posted
- 2020-01-06
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | 116 days | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | 116 days | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Low or Intermediate-1 MDS Group - Lirilumab | 1 | Participants | ||
| Overall Response Rate (ORR) | High Risk MDS Group - Azacitidine + Lirilumab | 6 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low or Intermediate-1 MDS Group - Lirilumab | 2 | |
| Overall Study | STARTED | Low or Intermediate-1 MDS Group - Nivolumab + Lirilumab | 0 | |
| Overall Study | STARTED | High Risk MDS Group - Azacitidine + Lirilumab | 8 | |
| Overall Study | STARTED | High Risk MDS Group - Azacitidine + Lirilumab + Nivolumab | 0 | |
| Overall Study | COMPLETED | Low or Intermediate-1 MDS Group - Lirilumab | 2 | |
| Overall Study | COMPLETED | Low or Intermediate-1 MDS Group - Nivolumab + Lirilumab | 0 | |
| Overall Study | COMPLETED | High Risk MDS Group - Azacitidine + Lirilumab | 8 | |
| Overall Study | COMPLETED | High Risk MDS Group - Azacitidine + Lirilumab + Nivolumab | 0 | |
| Overall Study | NOT COMPLETED | Low or Intermediate-1 MDS Group - Lirilumab | 0 | |
| Overall Study | NOT COMPLETED | Low or Intermediate-1 MDS Group - Nivolumab + Lirilumab | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events108
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hyperbilirubinemia | Investigations | Low or Intermediate-1 MDS Group - Lirilumab | 0 | 2 | 0 |
| other | Hyperbilirubinemia | Investigations | Low or Intermediate-1 MDS Group - Nivolumab + Lirilumab | 0 | 0 | 0 |
| other | Hyperbilirubinemia | Investigations | High Risk MDS Group - Azacitidine + Lirilumab | 1 | 8 | 1 |
| other | Hyperbilirubinemia | Investigations | High Risk MDS Group - Azacitidine + Lirilumab + Nivolumab | 0 | 0 | 0 |
| other | Colitis | Gastrointestinal disorders | Low or Intermediate-1 MDS Group - Lirilumab | 1 | 2 | 1 |
| other | Colitis | Gastrointestinal disorders | Low or Intermediate-1 MDS Group - Nivolumab + Lirilumab | 0 | 0 | 0 |
| other | Colitis | Gastrointestinal disorders | High Risk MDS Group - Azacitidine + Lirilumab | 0 | 8 | 0 |
| other | Colitis | Gastrointestinal disorders | High Risk MDS Group - Azacitidine + Lirilumab + Nivolumab | 0 | 0 | 0 |
| other | Constipation | Gastrointestinal disorders | Low or Intermediate-1 MDS Group - Lirilumab | 0 | 2 | 0 |
| other | Constipation | Gastrointestinal disorders | Low or Intermediate-1 MDS Group - Nivolumab + Lirilumab | 0 | 0 | 0 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low or Intermediate-1 MDS Group - Lirilumab | 0 | 2 |
| Total, all-cause mortality | Low or Intermediate-1 MDS Group - Nivolumab + Lirilumab | 0 | 0 |
| Total, all-cause mortality | High Risk MDS Group - Azacitidine + Lirilumab | 0 | 8 |
| Total, all-cause mortality | High Risk MDS Group - Azacitidine + Lirilumab + Nivolumab | 0 | 0 |
| Total, other adverse events | Low or Intermediate-1 MDS Group - Lirilumab | 1 | 2 |
| Total, other adverse events | Low or Intermediate-1 MDS Group - Nivolumab + Lirilumab | 0 | 0 |
| Total, other adverse events | High Risk MDS Group - Azacitidine + Lirilumab | 8 | 8 |
| Total, other adverse events | High Risk MDS Group - Azacitidine + Lirilumab + Nivolumab | 0 | 0 |
| Total, serious adverse events | Low or Intermediate-1 MDS Group - Lirilumab | 2 | 2 |
| Total, serious adverse events | Low or Intermediate-1 MDS Group - Nivolumab + Lirilumab | 0 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30001986 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02599649
GET https://conductscience.org/api/trials/v1/NCT02599649/events?page=2