TriangleNCT03312530 · OUTCOME
Percentage of Participants With Overall Response Rate (ORR) as Determined by the Investigator Using International Myeloma Working Group (IMWG) Response Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization to the first occurrence of a response as defined above (up to approximately 3 years, 7 months)
What was measured
ORR was defined as a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) and was analyzed in the safety evaluable population and in the biomarker-selected sub-populations of t(11;14) and RAS mutations.
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
Safety Population
| 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 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Safety Run-In: Cobimetinib + Venetoclax | 16.7 | Not reported | 0.00 | 54.82 | Not reported |
| Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | 33.3 | Not reported | 0.00 | 79.39 | Not reported |
| A: Cobimetinib | 0 | Not reported | 0.0 | 8.33 | Not reported |
| B: Cobimetinib + Venetoclax | 31.3 | Not reported | 5.41 | 57.09 | Not reported |
| C: Cobimetinib + Venetoclax + Atezolizumab | 26.7 | Not reported | 0.95 | 52.38 | Not reported |
t(11;14) Population
| Group | Source count |
|---|---|
| Safety Run-In: Cobimetinib + Venetoclax | 0 |
| Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | 1 |
| A: Cobimetinib | 1 |
| B: Cobimetinib + Venetoclax | 2 |
| C: Cobimetinib + Venetoclax + Atezolizumab | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | 100 | Not reported | 50.00 | 100.00 | Not reported |
| A: Cobimetinib | 0 | Not reported | 0.00 | 50.00 | Not reported |
| B: Cobimetinib + Venetoclax | 100 | Not reported | 75.00 | 100.00 | Not reported |
| C: Cobimetinib + Venetoclax + Atezolizumab | 80.0 | Not reported | 34.94 | 100.00 | Not reported |
RAS Mutation Population
| Group | Source count |
|---|---|
| Safety Run-In: Cobimetinib + Venetoclax | 2 |
| Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | 1 |
| A: Cobimetinib | 2 |
| B: Cobimetinib + Venetoclax | 7 |
| C: Cobimetinib + Venetoclax + Atezolizumab | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Safety Run-In: Cobimetinib + Venetoclax | 0 | Not reported | 0.00 | 25.00 | Not reported |
| Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab | 100 | Not reported | 50.00 | 100.00 | Not reported |
| A: Cobimetinib | 0 | Not reported | 0.00 | 25.00 | Not reported |
| B: Cobimetinib + Venetoclax | 14.3 | Not reported | 0.00 | 47.35 | Not reported |
| C: Cobimetinib + Venetoclax + Atezolizumab | 37.5 | Not reported | 0.00 | 77.30 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- 54.82
- value
- 16.7
- group Id
- OG001
- lower Limit
- 0.00
- upper Limit
- 79.39
- value
- 33.3
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 8.33
- value
- 0
- group Id
- OG003
- lower Limit
- 5.41
- upper Limit
- 57.09
- value
- 31.3
- group Id
- OG004
- lower Limit
- 0.95
- upper Limit
- 52.38
- value
- 26.7
- 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
- title
- Safety Population
- categories
- measurements
- group Id
- OG001
- lower Limit
- 50.00
- upper Limit
- 100.00
- value
- 100
- group Id
- OG002
- lower Limit
- 0.00
- upper Limit
- 50.00
- value
- 0
- group Id
- OG003
- lower Limit
- 75.00
- upper Limit
- 100.00
- value
- 100
- group Id
- OG004
- lower Limit
- 34.94
- upper Limit
- 100.00
- value
- 80.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 5
- units
- Participants
- title
- t(11;14) Population
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- 25.00
- value
- 0
- group Id
- OG001
- lower Limit
- 50.00
- upper Limit
- 100.00
- value
- 100
- group Id
- OG002
- lower Limit
- 0.00
- upper Limit
- 25.00
- value
- 0
- group Id
- OG003
- lower Limit
- 0.00
- upper Limit
- 47.35
- value
- 14.3
- group Id
- OG004
- lower Limit
- 0.00
- upper Limit
- 77.30
- value
- 37.5
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 8
- units
- Participants
- title
- RAS Mutation Population
- 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
- ORR was defined as a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) and was analyzed in the safety evaluable population and in the biomarker-selected sub-populations of t(11;14) and RAS mutations.
- 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
- NUMBER
- population Description
- The safety evaluable population included all participants who received any amount of study drug.
- reporting Status
- POSTED
- time Frame
- From randomization to the first occurrence of a response as defined above (up to approximately 3 years, 7 months)
- title
- Percentage of Participants With Overall Response Rate (ORR) as Determined by the Investigator Using International Myeloma Working Group (IMWG) Response Criteria
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice