GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. 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

Progression-free survival (PFS) is defined as the time from randomization to the first documented occurrence of disease progression (PD) or death. PFS for investigator-assessed and blinded, independent, central review committee (BRIC)-assessed responses was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Primary Efficacy Population included all participants with BRAF V600E mutation-positive melanoma without a history of brain metastases.

Primary Efficacy Population

→

secondary · POSTED

PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed and BRIC-assessed PFS were summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Intend-To-Treat (ITT) Population included all randomized participants regardless of whether or not treatment was administered.

ITT Population

→

secondary · POSTED

PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.

Primary Efficacy Population

→

secondary · POSTED

PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.

Primary Efficacy Population

→

secondary · POSTED

Overall survival was defined as the time from the date of randomization to the date of death due to any cause.

ITT Population

→

secondary · POSTED

Overall survival was defined as the time from the date of randomization to the date of death due to any cause. NA indicates data was not available.

Primary Efficacy Population

→

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

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-melanoma-keytruda-qlex-b6745983
nct id: NCT01245062
trial label: GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. 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: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01245062
outcome key
om-0000
source section id
NCT01245062-om-0000
source outcome index
0
endpoint
Progression-free Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases as Assessed by the Investigator and Independent Review
endpoint definition
Progression-free survival (PFS) is defined as the time from randomization to the first documented occurrence of disease progression (PD) or death. PFS for investigator-assessed and blinded, independent, central review committee (BRIC)-assessed responses was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Primary Efficacy Population included all participants with BRAF V600E mutation-positive melanoma without a history of brain metastases.
time origin
Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Primary Efficacy Population
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-keytruda-qlex-b6745983
nct id
NCT01245062
outcome key
om-0001
source section id
NCT01245062-om-0001
source outcome index
1
endpoint
Progression-free Survival in All Participants
endpoint definition
PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed and BRIC-assessed PFS were summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Intend-To-Treat (ITT) Population included all randomized participants regardless of whether or not treatment was administered.
time origin
Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT Population
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-keytruda-qlex-b6745983
nct id
NCT01245062
outcome key
om-0002
source section id
NCT01245062-om-0002
source outcome index
2
endpoint
PFS in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases and Without Prior Chemotherapy as Assessed by the Investigator
endpoint definition
PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.
time origin
Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Primary Efficacy Population
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-keytruda-qlex-b6745983
nct id
NCT01245062
outcome key
om-0003
source section id
NCT01245062-om-0003
source outcome index
3
endpoint
PFS in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases and With Prior Chemotherapy as Assessed by the Investigator
endpoint definition
PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.
time origin
Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Primary Efficacy Population
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-keytruda-qlex-b6745983
nct id
NCT01245062
outcome key
om-0004
source section id
NCT01245062-om-0004
source outcome index
4
endpoint
Overall Survival in All Participants
endpoint definition
Overall survival was defined as the time from the date of randomization to the date of death due to any cause.
time origin
Day 1 until death due to any cause (average of 20.3 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT Population
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-keytruda-qlex-b6745983
nct id
NCT01245062
outcome key
om-0005
source section id
NCT01245062-om-0005
source outcome index
5
endpoint
Overall Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases
endpoint definition
Overall survival was defined as the time from the date of randomization to the date of death due to any cause. NA indicates data was not available.
time origin
Day 1 until death due to any cause (average of 20.3 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Primary Efficacy Population
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-keytruda-qlex-b6745983
nct id
NCT01245062
outcome key
om-0000
arm key
OG000
arm label
Trametinib
regimen
Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
analyzed count
178
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01245062-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01245062
outcome key
om-0000
arm key
OG001
arm label
Chemotherapy
regimen
Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
analyzed count
95
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01245062-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01245062
outcome key
om-0001
arm key
OG000
arm label
Trametinib
regimen
Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
analyzed count
214
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01245062-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01245062
outcome key
om-0001
arm key
OG001
arm label
Chemotherapy
regimen
Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
analyzed count
108
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01245062-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01245062
outcome key
om-0002
arm key
OG000
arm label
Trametinib
regimen
Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
analyzed count
114
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01245062-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01245062
outcome key
om-0002
arm key
OG001
arm label
Chemotherapy
regimen
Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
analyzed count
62
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01245062-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01245062
outcome key
om-0003
arm key
OG000
arm label
Trametinib
regimen
Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
analyzed count
64
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01245062-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01245062
outcome key
om-0003
arm key
OG001
arm label
Chemotherapy
regimen
Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
analyzed count
33
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01245062-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01245062
outcome key
om-0004
arm key
OG000
arm label
Trametinib
regimen
Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
analyzed count
214
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01245062-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01245062
outcome key
om-0004
arm key
OG001
arm label
Chemotherapy
regimen
Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
analyzed count
108
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01245062-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01245062
outcome key
om-0005
arm key
OG000
arm label
Trametinib
regimen
Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
analyzed count
178
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01245062-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01245062
outcome key
om-0005
arm key
OG001
arm label
Chemotherapy
regimen
Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
analyzed count
95
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01245062-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01245062
harm key
EG000
source section id
NCT01245062-ae
event group key
EG000
event group label
Trametinib
serious affected
52
serious at risk
211
other affected
207
other at risk
211
frequency threshold
5
collection period
Participants were analyzed from the first dose of study medication to 28 days after discontinuation of study medication (average of 20.3 months in the Randomization Phase and 18.3 months in the Cross-over Phase).
event definition
Serious adverse events (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all randomized participants included in the study 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-keytruda-qlex-b6745983
nct id
NCT01245062
harm key
EG001
source section id
NCT01245062-ae
event group key
EG001
event group label
Chemotherapy
serious affected
19
serious at risk
99
other affected
88
other at risk
99
frequency threshold
5
collection period
Participants were analyzed from the first dose of study medication to 28 days after discontinuation of study medication (average of 20.3 months in the Randomization Phase and 18.3 months in the Cross-over Phase).
event definition
Serious adverse events (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all randomized participants included in the study 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-keytruda-qlex-b6745983
nct id
NCT01245062
harm key
EG002
source section id
NCT01245062-ae
event group key
EG002
event group label
Cross-over From Chemotherapy to Trametinib
serious affected
18
serious at risk
70
other affected
66
other at risk
70
frequency threshold
5
collection period
Participants were analyzed from the first dose of study medication to 28 days after discontinuation of study medication (average of 20.3 months in the Randomization Phase and 18.3 months in the Cross-over Phase).
event definition
Serious adverse events (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all randomized participants included in the study 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

setting source links

Preserved source evidence · Not medical advice