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NCT02908672 · OUTCOME

Serum Concentration of Atezolizumab

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
MEAN
Unit
micrograms per milliliters (ug/mL)
Interval / dispersion
Standard Deviation
Time frame
Pre-infusion Day 1 of Cycles 1-4; 30 minutes post-infusion Day 1 of Cycles 1 and 4; at Atezolizumab discontinuation (up to approximately 33 months) (1 Cycle = 28 days)

Analysis population: Pharmacokinetic (PK)-evaluable population included all participants who have received any dose of atezolizumab 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 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

GroupSource count
Arm B: Atezo + Cobi + Vem223

Reported measurements

Cycle 1 Day 1/30 Min Postdose

Analysis denominator · Participants

GroupSource count
Arm B: Atezo + Cobi + Vem187
Values in micrograms per milliliters (ug/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm B: Atezo + Cobi + Vem281111Not reportedNot reportedNot reported
Cycle 2 Day 1/Predose

Analysis denominator · Participants

GroupSource count
Arm B: Atezo + Cobi + Vem186
Values in micrograms per milliliters (ug/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm B: Atezo + Cobi + Vem10247.4Not reportedNot reportedNot reported
Cycle 3 Day 1/Predose

Analysis denominator · Participants

GroupSource count
Arm B: Atezo + Cobi + Vem171
Values in micrograms per milliliters (ug/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm B: Atezo + Cobi + Vem14961.9Not reportedNot reportedNot reported
Cycle 4 Day 1/Predose

Analysis denominator · Participants

GroupSource count
Arm B: Atezo + Cobi + Vem159
Values in micrograms per milliliters (ug/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm B: Atezo + Cobi + Vem18175.5Not reportedNot reportedNot reported
Cycle 4 Day 1/30 Min Postdose

Analysis denominator · Participants

GroupSource count
Arm B: Atezo + Cobi + Vem144
Values in micrograms per milliliters (ug/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm B: Atezo + Cobi + Vem431158Not reportedNot reportedNot reported
Study Drugs Discontinuation Visit

Analysis denominator · Participants

GroupSource count
Arm B: Atezo + Cobi + Vem101
Values in micrograms per milliliters (ug/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm B: Atezo + Cobi + Vem12297.7Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        111
        value
        281
    denoms
    1. counts
      1. group Id
        OG000
        value
        187
      units
      Participants
    title
    Cycle 1 Day 1/30 Min Postdose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        47.4
        value
        102
    denoms
    1. counts
      1. group Id
        OG000
        value
        186
      units
      Participants
    title
    Cycle 2 Day 1/Predose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        61.9
        value
        149
    denoms
    1. counts
      1. group Id
        OG000
        value
        171
      units
      Participants
    title
    Cycle 3 Day 1/Predose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        75.5
        value
        181
    denoms
    1. counts
      1. group Id
        OG000
        value
        159
      units
      Participants
    title
    Cycle 4 Day 1/Predose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        158
        value
        431
    denoms
    1. counts
      1. group Id
        OG000
        value
        144
      units
      Participants
    title
    Cycle 4 Day 1/30 Min Postdose
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        97.7
        value
        122
    denoms
    1. counts
      1. group Id
        OG000
        value
        101
      units
      Participants
    title
    Study Drugs Discontinuation Visit
denoms
  1. counts
    1. group Id
      OG000
      value
      223
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. 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
    OG000
    title
    Arm B: Atezo + Cobi + Vem
param Type
MEAN
population Description
Pharmacokinetic (PK)-evaluable population included all participants who have received any dose of atezolizumab 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-infusion Day 1 of Cycles 1-4; 30 minutes post-infusion Day 1 of Cycles 1 and 4; at Atezolizumab discontinuation (up to approximately 33 months) (1 Cycle = 28 days)
title
Serum Concentration of Atezolizumab
type
SECONDARY
unit Of Measure
micrograms per milliliters (ug/mL)

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Preserved source evidence · Not medical advice