TriangleNCT03312530 · OUTCOME
Progression-Free Survival (PFS) as Determined by the Investigator Using IMWG Response Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From enrollment or first treatment date to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to approximately 3 years, 7 months)
What was measured
PFS was defined as the time from randomization (for randomized participants) or first treatment date (for non-ranomized participants) to the first occurrence of disease progression or relapse as determined by the investigator using the IMWG criteria or death from any cause during the study, whichever occurred first.
Analysis population: The safety evaluable population included all participants who received any amount of study drug.
Groups in this outcome
Safety Run-In: Cobimetinib + Venetoclax
Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
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.
A: Cobimetinib
Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (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.
B: Cobimetinib + Venetoclax
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. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
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 | 6 |
| Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | 6 |
| A: Cobimetinib | 6 |
| B: Cobimetinib + Venetoclax | 16 |
| C: Cobimetinib + Venetoclax + Atezolizumab | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Safety Run-In: Cobimetinib + Venetoclax | 1.7 | Not reported | 0.9 | 3.7 | Not reported |
| Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | 3.4 | Not reported | 2.1 | 4.6 | Not reported |
| A: Cobimetinib | 2.8 | Not reported | 1.9 | 4.7 | Not reported |
| B: Cobimetinib + Venetoclax | 4.9 | Not reported | 1.9 | 10.3 | Not reported |
| C: Cobimetinib + Venetoclax + Atezolizumab | 3.8 | Not reported | 1.4 | 4.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.9
- upper Limit
- 3.7
- value
- 1.7
- group Id
- OG001
- lower Limit
- 2.1
- upper Limit
- 4.6
- value
- 3.4
- group Id
- OG002
- lower Limit
- 1.9
- upper Limit
- 4.7
- value
- 2.8
- group Id
- OG003
- lower Limit
- 1.9
- upper Limit
- 10.3
- value
- 4.9
- group Id
- OG004
- lower Limit
- 1.4
- upper Limit
- 4.7
- value
- 3.8
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 16
- group Id
- OG004
- value
- 15
- units
- Participants
- description
- PFS was defined as the time from randomization (for randomized participants) or first treatment date (for non-ranomized participants) to the first occurrence of disease progression or relapse as determined by the investigator using the IMWG criteria or death from any cause during the study, whichever occurred first.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
- id
- OG000
- title
- Safety Run-In: Cobimetinib + Venetoclax
- 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
- OG001
- title
- Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
- description
- Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (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
- OG002
- title
- A: Cobimetinib
- 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. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
- id
- OG003
- title
- B: Cobimetinib + Venetoclax
- 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
- OG004
- title
- C: Cobimetinib + Venetoclax + Atezolizumab
- param Type
- MEDIAN
- population Description
- The safety evaluable population included all participants who received any amount of study drug.
- reporting Status
- POSTED
- time Frame
- From enrollment or first treatment date to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to approximately 3 years, 7 months)
- title
- Progression-Free Survival (PFS) as Determined by the Investigator Using IMWG Response Criteria
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice