TriangleNCT02397720 · OUTCOME
Overall Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- Up to 7 years, 6 months
What was measured
Time from date of treatment start until date of death due to any cause or last Follow-up.
Analysis population: There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Groups in this outcome
Arm 1 A Lead-In (Azacitidine, Nivolumab)
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
Arm 1 B (Azacitidine, Nivolumab)
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
Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab)
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
Arm 2 B (Azacitidine, Nivolumab, Ipilimumab)
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
Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax)
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
| Group | Source count |
|---|---|
| Arm 1 A Lead-In (Azacitidine, Nivolumab) | 6 |
| Arm 1 B (Azacitidine, Nivolumab) | 85 |
| Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab) | 6 |
| Arm 2 B (Azacitidine, Nivolumab, Ipilimumab) | 47 |
| Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1 A Lead-In (Azacitidine, Nivolumab) | 5.9 | Not reported | 3.5 | 16.2 | Not reported |
| Arm 1 B (Azacitidine, Nivolumab) | 6.6 | Not reported | 0.3 | 90.0 | Not reported |
| Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab) | 8.3 | Not reported | 3.1 | 32.4 | Not reported |
| Arm 2 B (Azacitidine, Nivolumab, Ipilimumab) | 6.7 | Not reported | 0.4 | 71.5 | Not reported |
| Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) | 1.4 | Not reported | 1.0 | 8.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.5
- upper Limit
- 16.2
- value
- 5.9
- group Id
- OG001
- lower Limit
- 0.3
- upper Limit
- 90.0
- value
- 6.6
- group Id
- OG002
- lower Limit
- 3.1
- upper Limit
- 32.4
- value
- 8.3
- group Id
- OG003
- lower Limit
- 0.4
- upper Limit
- 71.5
- value
- 6.7
- group Id
- OG004
- lower Limit
- 1.0
- upper Limit
- 8.8
- value
- 1.4
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 85
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 47
- group Id
- OG004
- value
- 6
- units
- Participants
- description
- Time from date of treatment start until date of death due to any cause or last Follow-up.
- dispersion Type
- Full Range
- groups
- description
- 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
- id
- OG000
- title
- Arm 1 A Lead-In (Azacitidine, Nivolumab)
- description
- 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
- id
- OG001
- title
- Arm 1 B (Azacitidine, Nivolumab)
- description
- 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
- id
- OG002
- title
- Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab)
- description
- 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
- id
- OG003
- title
- Arm 2 B (Azacitidine, Nivolumab, Ipilimumab)
- description
- 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
- id
- OG004
- title
- Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax)
- param Type
- MEDIAN
- population Description
- There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
- reporting Status
- POSTED
- time Frame
- Up to 7 years, 6 months
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice