TriangleNCT02397720 · STUDY IN CONTEXT
Nivolumab and Azacitidine With or Without Ipilimumab in Treating Patients With Refractory/Relapsed or Newly Diagnosed Acute Myeloid Leukemia
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
The maximum tolerated dose is defined as the highest dose level of 5-azacitidine with \< 2 out of 6 patients experiencing a dose limiting toxicity during the first 28 days of treatment. The starting dose level for Azacitidine is 75 mg/m\^2 and the starting dose level for Nivolumab is 3.0 mg/kg.
Responders are patients who obtain a Complete Remission (CR), Complete Remission with Incomplete blood count recovery CRi, Complete Remission with Incomplete Platelet Recovery (CRp) or Partial Remission (PR), with or without cytogenetic response, hematologic improvements (HI), and morphologic leukemia-free state. CR is counts of 0 circulating blasts, Neutrophil count of \>/= 1.0 x 10\^9/L, Platelet count \>/= 100 x 10 \^9/L. Bone marrow \</= 5% blasts, No auer rods, No extramedullary disease. CRp is patients who have achieved a CR except for incomplete platelet recovery (\<100 x 10\^9/L). CRi is counts of 0 circulating blasts, Neutrophil count of \>/= 1.0 x 10\^9/L OR Platelet count \>/= 100 x 10 \^9/L. PR is All CR criteria if abnormal before treatment except \>/= 50% reduction in bone marrow blast but still \>5%. morphologic leukemia-free state is Bone marrow: \</=5% myeloblasts. HI is Hematologic response must be described by the number of positively affected cell lines.
The maximum tolerated dose is defined as the highest dose level of nivolumab with \< 2 out of 6 patients experiencing a dose limiting toxicity during the first 28 days of treatment. The starting dose level for Azacitidine is 75 mg/m\^2 and the starting dose level for Nivolumab is 3.0 mg/kg.
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Time from date of treatment start until date of death due to any cause or last Follow-up.
Time from date of treatment start until the date of progression or death from leukemia.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- trial label
- Nivolumab and Azacitidine With or Without Ipilimumab in Treating Patients With Refractory/Relapsed or Newly Diagnosed Acute Myeloid Leukemia
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 6
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- outcome key
- om-0000
- source section id
- NCT02397720-om-0000
- source outcome index
- 0
- endpoint
- Maximum Tolerated Dose of 5-azacytidine in the Combination of Nivolumab With Dihydro-5-azacytidine
- endpoint definition
- The maximum tolerated dose is defined as the highest dose level of 5-azacitidine with \< 2 out of 6 patients experiencing a dose limiting toxicity during the first 28 days of treatment. The starting dose level for Azacitidine is 75 mg/m\^2 and the starting dose level for Nivolumab is 3.0 mg/kg.
- time origin
- Up to 28 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants were treated at dose level 0, the starting dose.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- outcome key
- om-0001
- source section id
- NCT02397720-om-0001
- source outcome index
- 1
- endpoint
- Participants With a Response
- endpoint definition
- Responders are patients who obtain a Complete Remission (CR), Complete Remission with Incomplete blood count recovery CRi, Complete Remission with Incomplete Platelet Recovery (CRp) or Partial Remission (PR), with or without cytogenetic response, hematologic improvements (HI), and morphologic leukemia-free state. CR is counts of 0 circulating blasts, Neutrophil count of \>/= 1.0 x 10\^9/L, Platelet count \>/= 100 x 10 \^9/L. Bone marrow \</= 5% blasts, No auer rods, No extramedullary disease. CRp is patients who have achieved a CR except for incomplete platelet recovery (\<100 x 10\^9/L). CRi is counts of 0 circulating blasts, Neutrophil count of \>/= 1.0 x 10\^9/L OR Platelet count \>/= 100 x 10 \^9/L. PR is All CR criteria if abnormal before treatment except \>/= 50% reduction in bone marrow blast but still \>5%. morphologic leukemia-free state is Bone marrow: \</=5% myeloblasts. HI is Hematologic response must be described by the number of positively affected cell lines.
- time origin
- Up to 7 years, 6 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- outcome key
- om-0005
- source section id
- NCT02397720-om-0005
- source outcome index
- 5
- endpoint
- Maximum Tolerated Dose of Nivolumab in the Combination of Nivolumab With Dihydro-5-azacytidine
- endpoint definition
- The maximum tolerated dose is defined as the highest dose level of nivolumab with \< 2 out of 6 patients experiencing a dose limiting toxicity during the first 28 days of treatment. The starting dose level for Azacitidine is 75 mg/m\^2 and the starting dose level for Nivolumab is 3.0 mg/kg.
- time origin
- Up to 28 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants were treated at dose level 0, the starting dose.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- outcome key
- om-0002
- source section id
- NCT02397720-om-0002
- source outcome index
- 2
- endpoint
- Disease-free Survival
- endpoint definition
- Time from date of treatment start until the date of first objective documentation of disease-relapse.
- time origin
- Up to 7 years, 6 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- outcome key
- om-0003
- source section id
- NCT02397720-om-0003
- source outcome index
- 3
- endpoint
- Overall Survival
- endpoint definition
- Time from date of treatment start until date of death due to any cause or last Follow-up.
- time origin
- Up to 7 years, 6 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- outcome key
- om-0004
- source section id
- NCT02397720-om-0004
- source outcome index
- 4
- endpoint
- Progression-free Survival
- endpoint definition
- Time from date of treatment start until the date of progression or death from leukemia.
- time origin
- Up to 7 years, 6 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm 1 A Lead-In (Azacitidine, Nivolumab)
- regimen
- Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02397720-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab)
- regimen
- Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02397720-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax)
- regimen
- Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02397720-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm 1 A Lead-In (Azacitidine, Nivolumab)
- regimen
- Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02397720-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm 1 B (Azacitidine, Nivolumab)
- regimen
- Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV
- analyzed count
- 85
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02397720-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab)
- regimen
- Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02397720-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- outcome key
- om-0001
- arm key
- OG003
- arm label
- Arm 2 B (Azacitidine, Nivolumab, Ipilimumab)
- regimen
- Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV
- analyzed count
- 47
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02397720-om-0001#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- outcome key
- om-0001
- arm key
- OG004
- arm label
- Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax)
- regimen
- Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02397720-om-0001#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm 1 A Lead-In (Azacitidine, Nivolumab)
- regimen
- Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02397720-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm 1 B (Azacitidine, Nivolumab)
- regimen
- Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV
- analyzed count
- 34
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02397720-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab)
- regimen
- Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02397720-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- outcome key
- om-0002
- arm key
- OG003
- arm label
- Arm 2 B (Azacitidine, Nivolumab, Ipilimumab)
- regimen
- Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02397720-om-0002#groups/OG003
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- harm key
- EG000
- source section id
- NCT02397720-ae
- event group key
- EG000
- event group label
- Arm 1 A Lead-In (Azacitidine, Nivolumab)
- serious affected
- 6
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 5
- collection period
- Up to 7 years, 6 months
- event definition
- There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- harm key
- EG001
- source section id
- NCT02397720-ae
- event group key
- EG001
- event group label
- Arm 1 B (Azacitidine, Nivolumab)
- serious affected
- 57
- serious at risk
- 85
- other affected
- 62
- other at risk
- 85
- frequency threshold
- 5
- collection period
- Up to 7 years, 6 months
- event definition
- There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- harm key
- EG002
- source section id
- NCT02397720-ae
- event group key
- EG002
- event group label
- Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab)
- serious affected
- 2
- serious at risk
- 6
- other affected
- 5
- other at risk
- 6
- frequency threshold
- 5
- collection period
- Up to 7 years, 6 months
- event definition
- There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- harm key
- EG003
- source section id
- NCT02397720-ae
- event group key
- EG003
- event group label
- Arm 2 B (Azacitidine, Nivolumab, Ipilimumab)
- serious affected
- 33
- serious at risk
- 47
- other affected
- 25
- other at risk
- 47
- frequency threshold
- 5
- collection period
- Up to 7 years, 6 months
- event definition
- There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- harm key
- EG004
- source section id
- NCT02397720-ae
- event group key
- EG004
- event group label
- Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax)
- serious affected
- 5
- serious at risk
- 6
- other affected
- 4
- other at risk
- 6
- frequency threshold
- 5
- collection period
- Up to 7 years, 6 months
- event definition
- There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-biphenotypic-leukemia
- nct id
- NCT02397720
- harm key
- EG005
- source section id
- NCT02397720-ae
- event group key
- EG005
- event group label
- Arm 3 B (Azacitidine, Nivolumab, Venetoclax)
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 5
- collection period
- Up to 7 years, 6 months
- event definition
- There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice