Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous 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.

post-hoc · POSTED

Pre-treatment deaths were collected from screening visit up to the first day of treatment, for a maximum duration of 28 days. Patients who died during the screening period are considered as screen failure. On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 81.1 months (treatment duration ranged from 0.1 to 80.1 months). Deaths post treatment survival follow up were collected after the on- treatment period, up to approximately 6 years. Patients who didn't die during the on-treatment period and had not stopped study participation at the time of data cut-off (end of study) were censored.

Clinical database population; all treated patients and patients who died during screening.

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primary · POSTED

Overall Survival (OS) was defined as the interval of time between the date of randomization and the date of death due to any cause. For patients who did not die, OS was censored at the date of last contact.

Intent-to-Treat (ITT) Population.

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secondary · POSTED

Progression-free survival (PFS) was defined as the interval of time between the date of randomization and the first documented occurrence of disease progression or death due to any cause. PFS for investigator-assessed response was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Disease progression was 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.

Intent-to-Treat (ITT) Population.

→

secondary · POSTED

Overall response was defined as the percentage of confirmed responders (complete response \[CR\] + partial response \[PR\] per RECIST, Version 1.1) as summarized by Investigator assessment. CR was defined as the disappearance of all evidence of target lesions. PR was defined as at least a 30% reduction from Baseline in the sum of the longest diameter (LD) of all target lesions. Data were reported as those participants with measureable disease at Baseline.

Intent-to-Treat (ITT) Population. Only participants with measurable disease at baseline were included.

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secondary · POSTED

Duration of Response (DOR) was defined as the time from the first documented evidence of a CR (disappearance of all evidence of target lesions) or a PR (at least a 30% reduction from Baseline in the sum of the longest diameter of all target lesions) until disease progression or death due to any cause. PD was 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 at least1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Data were summarized per RECIST, Version 1.1.

Intent-to-Treat (ITT) Population. Only participants with confirmed response by RECIST version 1.1 were included.

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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: NCT01597908
trial label: Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous 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: 5
harms Count: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01597908
outcome key
om-0004
source section id
NCT01597908-om-0004
source outcome index
4
endpoint
All Collected Deaths
endpoint definition
Pre-treatment deaths were collected from screening visit up to the first day of treatment, for a maximum duration of 28 days. Patients who died during the screening period are considered as screen failure. On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 81.1 months (treatment duration ranged from 0.1 to 80.1 months). Deaths post treatment survival follow up were collected after the on- treatment period, up to approximately 6 years. Patients who didn't die during the on-treatment period and had not stopped study participation at the time of data cut-off (end of study) were censored.
time origin
up to 28 days before Day 1 (Screening), up to 81.1 months (on-treatment), up to approximately 6 years (study duration)
analysis role
post-hoc
reporting status
POSTED
data cutoff
Source null
population note
Clinical database population; all treated patients and patients who died during screening.
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
NCT01597908
outcome key
om-0000
source section id
NCT01597908-om-0000
source outcome index
0
endpoint
Overall Survival (OS)
endpoint definition
Overall Survival (OS) was defined as the interval of time between the date of randomization and the date of death due to any cause. For patients who did not die, OS was censored at the date of last contact.
time origin
From the date of randomization until date of death due to any cause (up to approximately 6 years)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Intent-to-Treat (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
NCT01597908
outcome key
om-0001
source section id
NCT01597908-om-0001
source outcome index
1
endpoint
Progression-Free Survival (PFS), as Assessed by the Investigator
endpoint definition
Progression-free survival (PFS) was defined as the interval of time between the date of randomization and the first documented occurrence of disease progression or death due to any cause. PFS for investigator-assessed response was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Disease progression was 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.
time origin
From randomization until the earliest date of disease progression (PD) or death due to any cause (up to approximately 6 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intent-to-Treat (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
NCT01597908
outcome key
om-0002
source section id
NCT01597908-om-0002
source outcome index
2
endpoint
Overall Response Rate (ORR) During Randomized Phase, as Assessed by the Investigator
endpoint definition
Overall response was defined as the percentage of confirmed responders (complete response \[CR\] + partial response \[PR\] per RECIST, Version 1.1) as summarized by Investigator assessment. CR was defined as the disappearance of all evidence of target lesions. PR was defined as at least a 30% reduction from Baseline in the sum of the longest diameter (LD) of all target lesions. Data were reported as those participants with measureable disease at Baseline.
time origin
From randomization until the first documented complete response or partial response (up to approximately 6 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intent-to-Treat (ITT) Population. Only participants with measurable disease at baseline were included.
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
NCT01597908
outcome key
om-0003
source section id
NCT01597908-om-0003
source outcome index
3
endpoint
Duration of Response (DOR), as Assessed by the Investigator
endpoint definition
Duration of Response (DOR) was defined as the time from the first documented evidence of a CR (disappearance of all evidence of target lesions) or a PR (at least a 30% reduction from Baseline in the sum of the longest diameter of all target lesions) until disease progression or death due to any cause. PD was 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 at least1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Data were summarized per RECIST, Version 1.1.
time origin
From the time of the first documented response (CR or PR) until disease progression (up to approximately 6 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intent-to-Treat (ITT) Population. Only participants with confirmed response by RECIST version 1.1 were included.
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
NCT01597908
outcome key
om-0000
arm key
OG000
arm label
Dabrafenib Plus Trametinib
regimen
Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.
analyzed count
352
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01597908-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01597908
outcome key
om-0000
arm key
OG001
arm label
Vemurafenib
regimen
Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.
analyzed count
352
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01597908-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01597908
outcome key
om-0001
arm key
OG000
arm label
Dabrafenib Plus Trametinib
regimen
Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.
analyzed count
352
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01597908-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01597908
outcome key
om-0001
arm key
OG001
arm label
Vemurafenib
regimen
Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.
analyzed count
352
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01597908-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01597908
outcome key
om-0002
arm key
OG000
arm label
Dabrafenib Plus Trametinib
regimen
Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.
analyzed count
351
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01597908-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01597908
outcome key
om-0002
arm key
OG001
arm label
Vemurafenib
regimen
Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.
analyzed count
350
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01597908-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01597908
outcome key
om-0003
arm key
OG000
arm label
Dabrafenib Plus Trametinib
regimen
Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.
analyzed count
237
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01597908-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01597908
outcome key
om-0003
arm key
OG001
arm label
Vemurafenib
regimen
Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.
analyzed count
185
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01597908-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01597908
outcome key
om-0004
arm key
OG000
arm label
Dabrafenib Plus Trametinib
regimen
Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.
analyzed count
351
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01597908-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01597908
outcome key
om-0004
arm key
OG001
arm label
Vemurafenib
regimen
Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.
analyzed count
349
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01597908-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01597908
outcome key
om-0004
arm key
OG002
arm label
Crossover Dabrafenib + Trametinib
regimen
With Protocol Amendment 7, patients still receiving study treatment on the Vemurafenib monotherapy arm were allowed to cross over to the Dabrafenib and Trametinib combination arm.
analyzed count
34
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01597908-om-0004#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01597908
harm key
EG000
source section id
NCT01597908-ae
event group key
EG000
event group label
Dabrafenib Plus Trametinib
serious affected
172
serious at risk
350
other affected
338
other at risk
350
frequency threshold
5
collection period
Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 81.1 months (treatment duration ranged from 0.1 to 80.1 months). In addition, new malignancies and AEs possibly related to study treatment were collected up to approximately 6 years
event definition
Any clinically significant sign or symptom that occurs during the study treatment and 30 days post treatment follow up. In addition, new malignancies and AEs possibly related to study treatment were collected even if they occurred more than 30 days post-treatment.
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
NCT01597908
harm key
EG001
source section id
NCT01597908-ae
event group key
EG001
event group label
Vemurafenib
serious affected
139
serious at risk
349
other affected
341
other at risk
349
frequency threshold
5
collection period
Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 81.1 months (treatment duration ranged from 0.1 to 80.1 months). In addition, new malignancies and AEs possibly related to study treatment were collected up to approximately 6 years
event definition
Any clinically significant sign or symptom that occurs during the study treatment and 30 days post treatment follow up. In addition, new malignancies and AEs possibly related to study treatment were collected even if they occurred more than 30 days post-treatment.
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
NCT01597908
harm key
EG002
source section id
NCT01597908-ae
event group key
EG002
event group label
Crossover Dabrafenib Plus Trametinib
serious affected
15
serious at risk
34
other affected
32
other at risk
34
frequency threshold
5
collection period
Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 81.1 months (treatment duration ranged from 0.1 to 80.1 months). In addition, new malignancies and AEs possibly related to study treatment were collected up to approximately 6 years
event definition
Any clinically significant sign or symptom that occurs during the study treatment and 30 days post treatment follow up. In addition, new malignancies and AEs possibly related to study treatment were collected even if they occurred more than 30 days post-treatment.
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
NCT01597908
harm key
EG003
source section id
NCT01597908-ae
event group key
EG003
event group label
All Patients
serious affected
319
serious at risk
699
other affected
679
other at risk
699
frequency threshold
5
collection period
Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 81.1 months (treatment duration ranged from 0.1 to 80.1 months). In addition, new malignancies and AEs possibly related to study treatment were collected up to approximately 6 years
event definition
Any clinically significant sign or symptom that occurs during the study treatment and 30 days post treatment follow up. In addition, new malignancies and AEs possibly related to study treatment were collected even if they occurred more than 30 days post-treatment.
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