TriangleNCT03312530 · OUTCOME
Percentage of Participants With Anti-Drug Antibody (ADA) to Atezolizumab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Pre-infusion (0 hr) on Day 1 of Cycles 1, 2, 3 (cycle length: 28 days); at treatment discontinuation visit (up to approximately 3 years, 7 months)
Analysis population: The immunogenicity analysis population for atezolizumab consisted of all participants from Arm C with any ADA assessment.
Groups in this outcome
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
C: Cobimetinib + Venetoclax + Atezolizumab
Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
| Group | Source count |
|---|---|
| Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | 6 |
| C: Cobimetinib + Venetoclax + Atezolizumab | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | 3 | Not reported | Not reported | Not reported | Not reported |
| C: Cobimetinib + Venetoclax + Atezolizumab | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 14
- units
- Participants
- groups
- description
- Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
- id
- OG000
- title
- Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
- description
- Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
- id
- OG001
- title
- C: Cobimetinib + Venetoclax + Atezolizumab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The immunogenicity analysis population for atezolizumab consisted of all participants from Arm C with any ADA assessment.
- reporting Status
- POSTED
- time Frame
- Pre-infusion (0 hr) on Day 1 of Cycles 1, 2, 3 (cycle length: 28 days); at treatment discontinuation visit (up to approximately 3 years, 7 months)
- title
- Percentage of Participants With Anti-Drug Antibody (ADA) to Atezolizumab
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice