NCT02908672 · OUTCOME
Plasma Concentration of Vemurafenib
A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma · Source last updated 2025-07-20
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- μg/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pre-dose (0 hour) and 3 to 6 hours post dose on Day 15 of Cycles 1 and 4 (1 Cycle = 28 days)
Analysis population: The Vem PK-evaluable population included all participants who received any dose of vemurafenib and for whom at least one evaluable PK sample was collected. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Groups in this outcome
Arm A: Pbo + Cobi + Vem
Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Arm B: Atezo + Cobi + Vem
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A: Pbo + Cobi + Vem | 218 |
|---|
| Arm B: Atezo + Cobi + Vem | 209 |
|---|
Reported measurements
Cycle 1 Day 15/ predose
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A: Pbo + Cobi + Vem | 199 |
|---|
| Arm B: Atezo + Cobi + Vem | 179 |
|---|
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Pbo + Cobi + Vem | 38.9 | 100 | Not reported | Not reported | Not reported |
|---|
| Arm B: Atezo + Cobi + Vem | 27.0 | 102 | Not reported | Not reported | Not reported |
|---|
Cycle 1 Day 15/ 3-6 hr
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A: Pbo + Cobi + Vem | 205 |
|---|
| Arm B: Atezo + Cobi + Vem | 168 |
|---|
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Pbo + Cobi + Vem | 41.3 | 57.7 | Not reported | Not reported | Not reported |
|---|
| Arm B: Atezo + Cobi + Vem | 28.0 | 88.6 | Not reported | Not reported | Not reported |
|---|
Cycle 4 Day 15/ predose
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A: Pbo + Cobi + Vem | 168 |
|---|
| Arm B: Atezo + Cobi + Vem | 158 |
|---|
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Pbo + Cobi + Vem | 39.2 | 105 | Not reported | Not reported | Not reported |
|---|
| Arm B: Atezo + Cobi + Vem | 24.7 | 202 | Not reported | Not reported | Not reported |
|---|
Cycle 4 Day 15/ 3-6 hr postdose
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A: Pbo + Cobi + Vem | 168 |
|---|
| Arm B: Atezo + Cobi + Vem | 154 |
|---|
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Pbo + Cobi + Vem | 42.3 | 59.4 | Not reported | Not reported | Not reported |
|---|
| Arm B: Atezo + Cobi + Vem | 26.5 | 135 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 100
- value
- 38.9
- group Id
- OG001
- spread
- 102
- value
- 27.0
- denoms
- counts
- group Id
- OG000
- value
- 199
- group Id
- OG001
- value
- 179
- units
- Participants
- title
- Cycle 1 Day 15/ predose
- categories
- measurements
- group Id
- OG000
- spread
- 57.7
- value
- 41.3
- group Id
- OG001
- spread
- 88.6
- value
- 28.0
- denoms
- counts
- group Id
- OG000
- value
- 205
- group Id
- OG001
- value
- 168
- units
- Participants
- title
- Cycle 1 Day 15/ 3-6 hr
- categories
- measurements
- group Id
- OG000
- spread
- 105
- value
- 39.2
- group Id
- OG001
- spread
- 202
- value
- 24.7
- denoms
- counts
- group Id
- OG000
- value
- 168
- group Id
- OG001
- value
- 158
- units
- Participants
- title
- Cycle 4 Day 15/ predose
- categories
- measurements
- group Id
- OG000
- spread
- 59.4
- value
- 42.3
- group Id
- OG001
- spread
- 135
- value
- 26.5
- denoms
- counts
- group Id
- OG000
- value
- 168
- group Id
- OG001
- value
- 154
- units
- Participants
- title
- Cycle 4 Day 15/ 3-6 hr postdose
- denoms
- counts
- group Id
- OG000
- value
- 218
- group Id
- OG001
- value
- 209
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
- id
- OG000
- title
- Arm A: Pbo + Cobi + Vem
- description
- Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
- id
- OG001
- title
- Arm B: Atezo + Cobi + Vem
- param Type
- GEOMETRIC_MEAN
- population Description
- The Vem PK-evaluable population included all participants who received any dose of vemurafenib and for whom at least one evaluable PK sample was collected. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
- reporting Status
- POSTED
- time Frame
- Pre-dose (0 hour) and 3 to 6 hours post dose on Day 15 of Cycles 1 and 4 (1 Cycle = 28 days)
- title
- Plasma Concentration of Vemurafenib
- type
- SECONDARY
- unit Of Measure
- μg/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle