Participant flow

Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma · Source last updated 2026-02-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants received 450 milligram (mg) of LGX818 orally once daily (QD) along with 45 mg of MEK162 twice daily (BID) for each 28 day treatment cycle until progressive disease (PD) as confirmed by Blinded Independent Review Committee (BIRC), withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.

   id

   FG000

   title

   Part 1: LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)

2. description

   Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.

   id

   FG001

   title

   Part 1: LGX818 300 mg

3. description

   Participants received 960 mg of Vemurafenib according to the locally approved prescribing information twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.

   id

   FG002

   title

   Part 1: Vemurafenib 960 mg BID

4. description

   Participants received 300 mg of LGX818 orally once daily along with 45 mg of MEK162 twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.

   id

   FG003

   title

   Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)

5. description

   Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.

   id

   FG004

   title

   Part 2: LGX818 300 mg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         24

      3. group Id

         FG002

         num Subjects

         25

      4. group Id

         FG003

         num Subjects

         25

      5. group Id

         FG004

         num Subjects

         9

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         4

      5. group Id

         FG004

         num Subjects

         1

      type

      Adverse Event

   4. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         11

      4. group Id

         FG003

         num Subjects

         8

      5. group Id

         FG004

         num Subjects

         2

      type

      New therapy for study indication

   5. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         11

      4. group Id

         FG003

         num Subjects

         10

      5. group Id

         FG004

         num Subjects

         2

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         74

      2. group Id

         FG001

         num Subjects

         81

      3. group Id

         FG002

         num Subjects

         82

      4. group Id

         FG003

         num Subjects

         93

      5. group Id

         FG004

         num Subjects

         31

      type

      Progressive disease

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      type

      Protocol Violation

   8. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         1

      type

      Study closure by Sponsor

   9. reasons

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         10

      3. group Id

         FG002

         num Subjects

         7

      4. group Id

         FG003

         num Subjects

         15

      5. group Id

         FG004

         num Subjects

         6

      type

      Subject/Guardian decision

   10. reasons

       1. group Id

          FG000

          num Subjects

          36

       2. group Id

          FG001

          num Subjects

          44

       3. group Id

          FG002

          num Subjects

          42

       4. group Id

          FG003

          num Subjects

          69

       5. group Id

          FG004

          num Subjects

          32

       type

       Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         192

      2. group Id

         FG001

         num Subjects

         194

      3. group Id

         FG002

         num Subjects

         191

      4. group Id

         FG003

         num Subjects

         258

      5. group Id

         FG004

         num Subjects

         86

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         16

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         30

      5. group Id

         FG004

         num Subjects

         2

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         170

      2. group Id

         FG001

         num Subjects

         178

      3. group Id

         FG002

         num Subjects

         185

      4. group Id

         FG003

         num Subjects

         228

      5. group Id

         FG004

         num Subjects

         84

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Study closure by sponsor was used for the end of study reason since the per-protocol final OS analysis was performed and the study ended by sponsor per the EOS.Participants remaining on treatment at that time were allowed to continue treatment and roll over into the FLOTILLA continuation study (C4221026/NCT05203172)or move to another treatment.

recruitment Details

A total of 921 participants were enrolled in this study.

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Preserved source evidence · Not medical advice