TriangleNCT01006980 · STUDY IN CONTEXT
A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)
Draft scope assessment: unclear. Attached because the study's own record names BRAF and 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
An Overall survival event was defined as death due to any cause. The number of participants with overall survival events is reported.
A progression-free survival (PFS) event was defined as disease progression or death due to any cause. Tumor response (progression) was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria using computed tomography (CT) scans or magnetic resonance imaging (MRI).
BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Participants who never received study treatment and treated participants without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion and no new lesion.
Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause. Duration of response was calculated only for participants who had a best overall response of Complete Response or Partial Response and was estimated using the Kaplan-Meier method.
Time to response was defined as the time from randomization to confirmed response (complete response or partial response).
Treatment failure was defined as a secondary endpoint in the protocol, defined as death, disease progression or premature withdrawal of study treatment. This endpoint was not included in the Statistical analysis plan; therefore no analyses of time to treatment failure were performed.
Reported safety
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-mekinist-8e4ae204
- nct id
- NCT01006980
- trial label
- A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)
- applicability
- unclear
- applicability note
- Attached because the study's own record names BRAF and 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-mekinist-8e4ae204
- nct id
- NCT01006980
- outcome key
- om-0000
- source section id
- NCT01006980-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival
- endpoint definition
- An Overall survival event was defined as death due to any cause. The number of participants with overall survival events is reported.
- time origin
- From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The intent-to-treat (ITT) population was defined as all randomized participants, whether or not study treatment was received. The ITT population was analyzed according to the treatment assigned at randomization. Overall survival was assessed on participants randomized at least 15 days prior to the clinical cutoff date of December 30, 2010.
- 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-mekinist-8e4ae204
- nct id
- NCT01006980
- outcome key
- om-0001
- source section id
- NCT01006980-om-0001
- source outcome index
- 1
- endpoint
- Progression-free Survival
- endpoint definition
- A progression-free survival (PFS) event was defined as disease progression or death due to any cause. Tumor response (progression) was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria using computed tomography (CT) scans or magnetic resonance imaging (MRI).
- time origin
- From randomization (initiated January 2010) to December 30 2010.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The analysis population for PFS consisted of all ITT participants randomized by October 27, 2010 (at least 9 weeks prior to the clinical cutoff date of December 30, 2010). The 9-week interval was chosen to allow time for participants to have had their first scheduled post baseline tumor assessment CT scan.
- 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-mekinist-8e4ae204
- nct id
- NCT01006980
- outcome key
- om-0002
- source section id
- NCT01006980-om-0002
- source outcome index
- 2
- endpoint
- Participants With a Best Overall Response (BOR) of Complete Response or Partial Response
- endpoint definition
- BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Participants who never received study treatment and treated participants without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion and no new lesion.
- time origin
- From randomization (initiated January 2010) until December 30, 2010
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The analysis population consisted of all ITT participants randomized by September 22, 2010 (at least 14 weeks prior to the clinical cutoff date of December 30, 2010). The 14-week interval was chosen as it was the minimum time needed to observe a confirmed overall response according to protocol-specified schedule for the first two tumor assessments.
- 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-mekinist-8e4ae204
- nct id
- NCT01006980
- outcome key
- om-0003
- source section id
- NCT01006980-om-0003
- source outcome index
- 3
- endpoint
- Duration of Response
- endpoint definition
- Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause. Duration of response was calculated only for participants who had a best overall response of Complete Response or Partial Response and was estimated using the Kaplan-Meier method.
- time origin
- From randomization (initiated in January 2010) until December 30, 2010.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The analysis population included all participants randomized by September 22, 2010 and with a best overall confirmed response of complete response or partial response.
- 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-mekinist-8e4ae204
- nct id
- NCT01006980
- outcome key
- om-0004
- source section id
- NCT01006980-om-0004
- source outcome index
- 4
- endpoint
- Time to Confirmed Response
- endpoint definition
- Time to response was defined as the time from randomization to confirmed response (complete response or partial response).
- time origin
- From randomization (initiated January 2010) until December 30, 2010.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The analysis population included all participants randomized by September 22, 2010 and with a best overall confirmed response of complete response or partial response.
- 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-mekinist-8e4ae204
- nct id
- NCT01006980
- outcome key
- om-0005
- source section id
- NCT01006980-om-0005
- source outcome index
- 5
- endpoint
- Time to Treatment Failure
- endpoint definition
- Treatment failure was defined as a secondary endpoint in the protocol, defined as death, disease progression or premature withdrawal of study treatment. This endpoint was not included in the Statistical analysis plan; therefore no analyses of time to treatment failure were performed.
- time origin
- approximately 3 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- 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-mekinist-8e4ae204
- nct id
- NCT01006980
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Vemurafenib
- regimen
- Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
- analyzed count
- 336
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01006980-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-mekinist-8e4ae204
- nct id
- NCT01006980
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Dacarbazine
- regimen
- Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
- analyzed count
- 336
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01006980-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-mekinist-8e4ae204
- nct id
- NCT01006980
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Vemurafenib
- regimen
- Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
- analyzed count
- 275
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01006980-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-mekinist-8e4ae204
- nct id
- NCT01006980
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Dacarbazine
- regimen
- Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
- analyzed count
- 274
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01006980-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-mekinist-8e4ae204
- nct id
- NCT01006980
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Vemurafenib
- regimen
- Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
- analyzed count
- 219
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01006980-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-mekinist-8e4ae204
- nct id
- NCT01006980
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Dacarbazine
- regimen
- Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
- analyzed count
- 220
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01006980-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-mekinist-8e4ae204
- nct id
- NCT01006980
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Vemurafenib
- regimen
- Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
- analyzed count
- 106
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01006980-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-mekinist-8e4ae204
- nct id
- NCT01006980
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Dacarbazine
- regimen
- Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01006980-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-mekinist-8e4ae204
- nct id
- NCT01006980
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Vemurafenib
- regimen
- Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
- analyzed count
- 106
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01006980-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-mekinist-8e4ae204
- nct id
- NCT01006980
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Dacarbazine
- regimen
- Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01006980-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-mekinist-8e4ae204
- nct id
- NCT01006980
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Vemurafenib
- regimen
- Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01006980-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-mekinist-8e4ae204
- nct id
- NCT01006980
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Dacarbazine
- regimen
- Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01006980-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-mekinist-8e4ae204
- nct id
- NCT01006980
- harm key
- EG000
- source section id
- NCT01006980-ae
- event group key
- EG000
- event group label
- Vemurafenib
- serious affected
- 165
- serious at risk
- 336
- other affected
- 333
- other at risk
- 336
- frequency threshold
- 5
- collection period
- Baseline through the end of study (maximum exposure: 57.07 months)
- event definition
- Source null
- 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-mekinist-8e4ae204
- nct id
- NCT01006980
- harm key
- EG001
- source section id
- NCT01006980-ae
- event group key
- EG001
- event group label
- Dacarbazine
- serious affected
- 52
- serious at risk
- 293
- other affected
- 247
- other at risk
- 293
- frequency threshold
- 5
- collection period
- Baseline through the end of study (maximum exposure: 57.07 months)
- event definition
- Source null
- 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-mekinist-8e4ae204
- nct id
- NCT01006980
- harm key
- EG002
- source section id
- NCT01006980-ae
- event group key
- EG002
- event group label
- Vemurafenib After Crossover
- serious affected
- 44
- serious at risk
- 84
- other affected
- 83
- other at risk
- 84
- frequency threshold
- 5
- collection period
- Baseline through the end of study (maximum exposure: 57.07 months)
- event definition
- Source null
- 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