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NCT02908672 · FLOW

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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.

groups
  1. description
    Participants received vemurafenib, 960 milligrams (mg) (four, 240 mg tablets), orally (PO), twice a day (BID) along with cobimetinib, 60 mg (three, 20 mg tablets) PO, once a day (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.
    id
    FG000
    title
    Run-in - Pbo + Cobi + Vem
  2. 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.
    id
    FG001
    title
    Run-in - Atezo + Cobi + Vem
  3. description
    After the 28-day run-in, 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 disease progression (PD), death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
    id
    FG002
    title
    Triple Combination: Pbo + Cobi + Vem
  4. description
    After the 28-day run-in period, 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
    FG003
    title
    Triple Combination: Atezo + Cobi + Vem
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Reason Not Specified
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Study Ended by Sponsor
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        258
      2. group Id
        FG001
        num Subjects
        256
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        234
      2. group Id
        FG001
        num Subjects
        234
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        22
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Run-in Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        150
      4. group Id
        FG003
        num Subjects
        127
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        8
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Reason Not Specified
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        61
      4. group Id
        FG003
        num Subjects
        77
      type
      Study Ended by Sponsor
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        16
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        231
      4. group Id
        FG003
        num Subjects
        230
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        231
      4. group Id
        FG003
        num Subjects
        230
      type
      NOT COMPLETED
    title
    Triple Combination Period
pre Assignment Details
Participants received either Placebo + Cobimetinib + Vemurafenib (Pbo+Cobi+Vem) or Atezolizumab + Cobimetinib + Vemurafenib (Atezo+Cobi+Vem). 26 participants were included in pbo+cobi+vem arm for safety analysis (22 in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in pbo+cobi+vem arm received atezo \& were included in the atezo+cobi+vem arm for safety analysis.
recruitment Details
A total of 514 participants with B-Raf proto-oncogene serine/threonine kinase (BRAF) V600 mutation positive metastatic or unresectable locally advanced melanoma took part in the study. The study had 2 periods: 28-day run-in period \& a triple combination period. The study was closed early by the sponsor due to the low likelihood of OS achieving statistical significance at final analysis \& slower-than-anticipated OS event accumulation. Hence, the study was considered to be completed.
Complete source fields
groups
  1. description
    Participants received vemurafenib, 960 milligrams (mg) (four, 240 mg tablets), orally (PO), twice a day (BID) along with cobimetinib, 60 mg (three, 20 mg tablets) PO, once a day (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.
    id
    FG000
    title
    Run-in - Pbo + Cobi + Vem
  2. 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.
    id
    FG001
    title
    Run-in - Atezo + Cobi + Vem
  3. description
    After the 28-day run-in, 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 disease progression (PD), death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
    id
    FG002
    title
    Triple Combination: Pbo + Cobi + Vem
  4. description
    After the 28-day run-in period, 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
    FG003
    title
    Triple Combination: Atezo + Cobi + Vem
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Reason Not Specified
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Study Ended by Sponsor
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        258
      2. group Id
        FG001
        num Subjects
        256
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        234
      2. group Id
        FG001
        num Subjects
        234
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        22
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Run-in Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        150
      4. group Id
        FG003
        num Subjects
        127
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        8
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Reason Not Specified
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        61
      4. group Id
        FG003
        num Subjects
        77
      type
      Study Ended by Sponsor
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        16
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        231
      4. group Id
        FG003
        num Subjects
        230
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        231
      4. group Id
        FG003
        num Subjects
        230
      type
      NOT COMPLETED
    title
    Triple Combination Period
pre Assignment Details
Participants received either Placebo + Cobimetinib + Vemurafenib (Pbo+Cobi+Vem) or Atezolizumab + Cobimetinib + Vemurafenib (Atezo+Cobi+Vem). 26 participants were included in pbo+cobi+vem arm for safety analysis (22 in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in pbo+cobi+vem arm received atezo \& were included in the atezo+cobi+vem arm for safety analysis.
recruitment Details
A total of 514 participants with B-Raf proto-oncogene serine/threonine kinase (BRAF) V600 mutation positive metastatic or unresectable locally advanced melanoma took part in the study. The study had 2 periods: 28-day run-in period \& a triple combination period. The study was closed early by the sponsor due to the low likelihood of OS achieving statistical significance at final analysis \& slower-than-anticipated OS event accumulation. Hence, the study was considered to be completed.

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