A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma

Draft scope assessment: unclear. Attached because the study's own record names BRAF. The study record does not state V600, so it may describe a different alteration of the same gene. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

DFS was defined as the time from randomization until the date of the first local, regional, or distant melanoma recurrence, occurrence of new primary melanoma, or death from any cause.

The ITT population included all participants enrolled in the study, whether or not they had received study medication.

→

secondary · POSTED

DMFS was defined as the time from randomization until the date of diagnosis of distant (i.e. non-locoregional) metastases or death from any cause.

The ITT population included all participants enrolled in the study, whether or not they had received study medication.

→

secondary · POSTED

OS is defined as the time from randomization until the date of death from any cause.

The ITT population included all participants enrolled in the study, whether or not they had received study medication.

→

secondary · POSTED

An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.

The safety population included all participants who received at least one dose of study medication.

→

secondary · POSTED

European Organisation for Research and Treatment of Cancer 30-Item Quality of Life Questionnaire assesses 8 symptoms, function, financial difficulties, and a global health status/health-related quality of life (HRQoL). Most questions use a 4-point scale (1 'Not at all' to 4 'Very much';2 questions use a 7-point scale (1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to a 0-100 scale. Higher scores for the function and HRQoL represent higher levels of functioning and HRQoL, higher scores for the symptom represent higher levels of symptoms/problems, higher score for financial difficulty represent higher level of perceived financial burden of treatment. Changes of 5-10 points are considered to represent a minimally important difference to participants. A positive value means an increase, and negative value means a decrease in score at the indicated time-point relative to the score at baseline (Cycle 1 Day 1).

The patient-reported outcome (PRO)-evaluable population included all participants who received at least one dose of vemurafenib and who had both a baseline assessment and at least one post-baseline QLQ-C30 assessment that generated a score.

→

secondary · POSTED

Plasma Concentration of Vemurafenib

The pharmacokinetic (PK)-evaluable population included all participants who received at least one dose of vemurafenib and had provided valid PK assessments.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-melanoma-tecentriq-hybreza-b9e46936
nct id: NCT01667419
qol key: qol-0004
source section id: NCT01667419-om-0004
source outcome index: 4
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score
measure definition: European Organisation for Research and Treatment of Cancer 30-Item Quality of Life Questionnaire assesses 8 symptoms, function, financial difficulties, and a global health status/health-related quality of life (HRQoL). Most questions use a 4-point scale (1 'Not at all' to 4 'Very much';2 questions use a 7-point scale (1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to a 0-100 scale. Higher scores for the function and HRQoL represent higher levels of functioning and HRQoL, higher scores for the symptom represent higher levels of symptoms/problems, higher score for financial difficulty represent higher level of perceived financial burden of treatment. Changes of 5-10 points are considered to represent a minimally important difference to participants. A positive value means an increase, and negative value means a decrease in score at the indicated time-point relative to the score at baseline (Cycle 1 Day 1).
time frame: Day 1, Day 8, Day 15, Day 22 of Cycle 1;Day 1, Day 15 of Cycle 2;Day 1 Cycles 3-13;end of treatment(up to 13 months);every 13 weeks thereafter until recurrence or occurrence of a new primary melanoma (up to 17-Apr-17 data cut-off,approximately 4.5 years)
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: The patient-reported outcome (PRO)-evaluable population included all participants who received at least one dose of vemurafenib and who had both a baseline assessment and at least one post-baseline QLQ-C30 assessment that generated a score.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-melanoma-tecentriq-hybreza-b9e46936
nct id: NCT01667419
trial label: A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma
applicability: unclear
applicability note: Attached because the study's own record names BRAF. The study record does not state V600, so it may describe a different alteration of the same gene. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 4
qol Count: 1

outcomes

release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
outcome key
om-0000
source section id
NCT01667419-om-0000
source outcome index
0
endpoint
Disease-Free Survival (DFS) as Assessed Using Contrast-Enhanced Magnetic Resonance Imaging (MRI) or Contrast Enhanced Computed Tomography (CT)
endpoint definition
DFS was defined as the time from randomization until the date of the first local, regional, or distant melanoma recurrence, occurrence of new primary melanoma, or death from any cause.
time origin
From randomization until the date of the first local, regional, or distant melanoma recurrence, occurrence of new primary melanoma, or death from any cause (up to the April 17, 2017 data cut-off, approximately 4.5 years)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The ITT population included all participants enrolled in the study, whether or not they had received study medication.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
outcome key
om-0001
source section id
NCT01667419-om-0001
source outcome index
1
endpoint
Distant Metastasis-Free Survival (DMFS) as Assessed Using Contrast-Enhanced MRI or Contrast Enhanced CT
endpoint definition
DMFS was defined as the time from randomization until the date of diagnosis of distant (i.e. non-locoregional) metastases or death from any cause.
time origin
From randomization until the date of diagnosis of distant (i.e., non-locoregional) metastases or death from any cause (up to the April 17, 2017 data cut-off, approximately 4.5 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The ITT population included all participants enrolled in the study, whether or not they had received study medication.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
outcome key
om-0002
source section id
NCT01667419-om-0002
source outcome index
2
endpoint
Overall Survival (OS)
endpoint definition
OS is defined as the time from randomization until the date of death from any cause.
time origin
From randomization until the date of death from any cause (up until 13-July-2018, approximately 6 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The ITT population included all participants enrolled in the study, whether or not they had received study medication.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
outcome key
om-0003
source section id
NCT01667419-om-0003
source outcome index
3
endpoint
Percentage of Participants With Adverse Events
endpoint definition
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
time origin
From randomization up to study completion or discontinuation (up until 13-July-2018, approximately 6 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The safety population included all participants who received at least one dose of study medication.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
outcome key
om-0004
source section id
NCT01667419-om-0004
source outcome index
4
endpoint
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score
endpoint definition
European Organisation for Research and Treatment of Cancer 30-Item Quality of Life Questionnaire assesses 8 symptoms, function, financial difficulties, and a global health status/health-related quality of life (HRQoL). Most questions use a 4-point scale (1 'Not at all' to 4 'Very much';2 questions use a 7-point scale (1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to a 0-100 scale. Higher scores for the function and HRQoL represent higher levels of functioning and HRQoL, higher scores for the symptom represent higher levels of symptoms/problems, higher score for financial difficulty represent higher level of perceived financial burden of treatment. Changes of 5-10 points are considered to represent a minimally important difference to participants. A positive value means an increase, and negative value means a decrease in score at the indicated time-point relative to the score at baseline (Cycle 1 Day 1).
time origin
Day 1, Day 8, Day 15, Day 22 of Cycle 1;Day 1, Day 15 of Cycle 2;Day 1 Cycles 3-13;end of treatment(up to 13 months);every 13 weeks thereafter until recurrence or occurrence of a new primary melanoma (up to 17-Apr-17 data cut-off,approximately 4.5 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The patient-reported outcome (PRO)-evaluable population included all participants who received at least one dose of vemurafenib and who had both a baseline assessment and at least one post-baseline QLQ-C30 assessment that generated a score.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
outcome key
om-0005
source section id
NCT01667419-om-0005
source outcome index
5
endpoint
Plasma Concentration of Vemurafenib
endpoint definition
Plasma Concentration of Vemurafenib
time origin
Pre-morning dose (0 hour [hr]) and 1 to 4 hrs post-dose on Days 1, 8, 15, and 22 of Cycle 1; pre-morning dose (0 hr) on Days 1 and 15 of Cycle 2; pre-morning dose (0 hr) on Day 1 of Cycles 3-13; at end of treatment (up to 13 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The pharmacokinetic (PK)-evaluable population included all participants who received at least one dose of vemurafenib and had provided valid PK assessments.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
outcome key
om-0000
arm key
OG000
arm label
Cohort 1 Vemurafenib
regimen
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
analyzed count
157
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01667419-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
outcome key
om-0000
arm key
OG001
arm label
Cohort 1 Placebo
regimen
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
analyzed count
157
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01667419-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
outcome key
om-0000
arm key
OG002
arm label
Cohort 2 Vemurafenib
regimen
Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
analyzed count
93
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01667419-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
outcome key
om-0000
arm key
OG003
arm label
Cohort 2 Placebo
regimen
Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
analyzed count
91
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01667419-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
outcome key
om-0001
arm key
OG000
arm label
Cohort 1 Vemurafenib
regimen
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
analyzed count
157
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01667419-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
outcome key
om-0001
arm key
OG001
arm label
Cohort 1 Placebo
regimen
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
analyzed count
157
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01667419-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
outcome key
om-0001
arm key
OG002
arm label
Cohort 2 Vemurafenib
regimen
Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
analyzed count
93
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01667419-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
outcome key
om-0001
arm key
OG003
arm label
Cohort 2 Placebo
regimen
Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
analyzed count
91
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01667419-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
outcome key
om-0002
arm key
OG000
arm label
Cohort 1 Vemurafenib
regimen
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
analyzed count
157
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01667419-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
outcome key
om-0002
arm key
OG001
arm label
Cohort 1 Placebo
regimen
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
analyzed count
157
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01667419-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
outcome key
om-0002
arm key
OG002
arm label
Cohort 2 Vemurafenib
regimen
Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
analyzed count
93
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01667419-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
outcome key
om-0002
arm key
OG003
arm label
Cohort 2 Placebo
regimen
Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
analyzed count
91
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01667419-om-0002#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
harm key
EG000
source section id
NCT01667419-ae
event group key
EG000
event group label
Cohort 1 Vemurafenib
serious affected
25
serious at risk
154
other affected
150
other at risk
154
frequency threshold
5
collection period
Up to the data cutoff of July 13, 2018 (approximately 6 years).
event definition
The safety population included all participants who received at least one dose of study medication.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
harm key
EG001
source section id
NCT01667419-ae
event group key
EG001
event group label
Cohort 1 Placebo
serious affected
16
serious at risk
156
other affected
117
other at risk
156
frequency threshold
5
collection period
Up to the data cutoff of July 13, 2018 (approximately 6 years).
event definition
The safety population included all participants who received at least one dose of study medication.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
harm key
EG002
source section id
NCT01667419-ae
event group key
EG002
event group label
Cohort 2 Vemurafenib
serious affected
15
serious at risk
93
other affected
92
other at risk
93
frequency threshold
5
collection period
Up to the data cutoff of July 13, 2018 (approximately 6 years).
event definition
The safety population included all participants who received at least one dose of study medication.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
harm key
EG003
source section id
NCT01667419-ae
event group key
EG003
event group label
Cohort 2 Placebo
serious affected
9
serious at risk
91
other affected
67
other at risk
91
frequency threshold
5
collection period
Up to the data cutoff of July 13, 2018 (approximately 6 years).
event definition
The safety population included all participants who received at least one dose of study medication.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

release id
clinical-indications-draft-1
disease state id
ds-melanoma-tecentriq-hybreza-b9e46936
nct id
NCT01667419
qol key
qol-0004
source section id
NCT01667419-om-0004
source outcome index
4
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score
measure definition
European Organisation for Research and Treatment of Cancer 30-Item Quality of Life Questionnaire assesses 8 symptoms, function, financial difficulties, and a global health status/health-related quality of life (HRQoL). Most questions use a 4-point scale (1 'Not at all' to 4 'Very much';2 questions use a 7-point scale (1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to a 0-100 scale. Higher scores for the function and HRQoL represent higher levels of functioning and HRQoL, higher scores for the symptom represent higher levels of symptoms/problems, higher score for financial difficulty represent higher level of perceived financial burden of treatment. Changes of 5-10 points are considered to represent a minimally important difference to participants. A positive value means an increase, and negative value means a decrease in score at the indicated time-point relative to the score at baseline (Cycle 1 Day 1).
time frame
Day 1, Day 8, Day 15, Day 22 of Cycle 1;Day 1, Day 15 of Cycle 2;Day 1 Cycles 3-13;end of treatment(up to 13 months);every 13 weeks thereafter until recurrence or occurrence of a new primary melanoma (up to 17-Apr-17 data cut-off,approximately 4.5 years)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The patient-reported outcome (PRO)-evaluable population included all participants who received at least one dose of vemurafenib and who had both a baseline assessment and at least one post-baseline QLQ-C30 assessment that generated a score.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice