TriangleNCT02397720 · OUTCOME
Maximum Tolerated Dose of Nivolumab in the Combination of Nivolumab With Dihydro-5-azacytidine
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- mg/kg
- Interval / dispersion
- Not reported
- Time frame
- Up to 28 days
What was measured
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.
Analysis population: All participants were treated at dose level 0, the starting dose.
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 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 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 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab) | 6 |
| 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) | 3 | Not reported | Not reported | Not reported | Not reported |
| Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab) | 3 | Not reported | Not reported | Not reported | Not reported |
| Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- 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.
- 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 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
- OG001
- title
- Arm 2 A Lead-In (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
- OG002
- title
- Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax)
- param Type
- NUMBER
- population Description
- All participants were treated at dose level 0, the starting dose.
- reporting Status
- POSTED
- time Frame
- Up to 28 days
- title
- Maximum Tolerated Dose of Nivolumab in the Combination of Nivolumab With Dihydro-5-azacytidine
- type
- PRIMARY
- unit Of Measure
- mg/kg
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice