TriangleNCT01682083 · STUDY IN CONTEXT
Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).
Draft scope assessment: unclear. Attached because the study's own record names BRAF. The study record does not state V600E, 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
Relapse-Free Survival (RFS) was defined as the time from randomization to disease recurrence or death from any cause. RFS events included loco-regional recurrence, distant metastases, new primary melanoma, and death without prior documented recurrence; such deaths were counted as events and not censored. Patients without an event at the analysis cut-off (30-Jun-2017) were censored at the date of the last radiological or non-radiological efficacy assessment. Patients lost to follow-up before recurrence or who initiated subsequent anti-cancer therapy prior to recurrence were censored at the last efficacy assessment before loss to follow-up or therapy initiation. Events after prolonged loss to follow-up were handled per the analysis plan. Malignancies other than new primary melanoma were not considered RFS events and, except for basal cell carcinoma, were reported as serious adverse events. Tumor tissue from any new primary cancer was collected for biomarker analyses.
Relapse-Free Survival (RFS) was defined as the time from randomization to disease recurrence or death from any cause. RFS events included loco-regional recurrence, distant metastases, new primary melanoma, and death without prior documented recurrence; such deaths were counted as events and not censored. Patients without an event at the analysis cut-off (30-Jun-2017) were censored at the date of the last radiological or non-radiological efficacy assessment. Patients lost to follow-up before recurrence or who initiated subsequent anti-cancer therapy prior to recurrence were censored at the last efficacy assessment before loss to follow-up or therapy initiation. Events after prolonged loss to follow-up were handled per the analysis plan. Malignancies other than new primary melanoma were not considered RFS events and, except for basal cell carcinoma, were reported as serious adverse events. Tumor tissue from any new primary cancer was collected for biomarker analyses.
Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
Overall Survival (OS) was defined as the interval from randomization to the date of death, irrespective of the cause of death. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
Distant metastasis-free survival (DMFS) was defined as the time from randomization to the first occurrence of distant metastasis or death, whichever occurred first, if death preceded documented recurrence. Patients who remained alive and free of distant metastasis were censored at the date of their last assessment.
Distant metastasis-free survival (DMFS) was defined as the time from randomization to the first occurrence of distant metastasis or death, whichever occurred first, if death preceded documented recurrence. Patients who remained alive and free of distant metastasis were censored at the date of their last assessment.
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-tafinlar-e3488bbf
- nct id
- NCT01682083
- trial label
- Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).
- applicability
- unclear
- applicability note
- Attached because the study's own record names BRAF. The study record does not state V600E, 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
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-tafinlar-e3488bbf
- nct id
- NCT01682083
- outcome key
- om-0000
- source section id
- NCT01682083-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants With Relapse-free Survival (RFS) Events
- endpoint definition
- Relapse-Free Survival (RFS) was defined as the time from randomization to disease recurrence or death from any cause. RFS events included loco-regional recurrence, distant metastases, new primary melanoma, and death without prior documented recurrence; such deaths were counted as events and not censored. Patients without an event at the analysis cut-off (30-Jun-2017) were censored at the date of the last radiological or non-radiological efficacy assessment. Patients lost to follow-up before recurrence or who initiated subsequent anti-cancer therapy prior to recurrence were censored at the last efficacy assessment before loss to follow-up or therapy initiation. Events after prolonged loss to follow-up were handled per the analysis plan. Malignancies other than new primary melanoma were not considered RFS events and, except for basal cell carcinoma, were reported as serious adverse events. Tumor tissue from any new primary cancer was collected for biomarker analyses.
- time origin
- Approximately 4 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-tafinlar-e3488bbf
- nct id
- NCT01682083
- outcome key
- om-0001
- source section id
- NCT01682083-om-0001
- source outcome index
- 1
- endpoint
- Relapse-free Survival (RFS)
- endpoint definition
- Relapse-Free Survival (RFS) was defined as the time from randomization to disease recurrence or death from any cause. RFS events included loco-regional recurrence, distant metastases, new primary melanoma, and death without prior documented recurrence; such deaths were counted as events and not censored. Patients without an event at the analysis cut-off (30-Jun-2017) were censored at the date of the last radiological or non-radiological efficacy assessment. Patients lost to follow-up before recurrence or who initiated subsequent anti-cancer therapy prior to recurrence were censored at the last efficacy assessment before loss to follow-up or therapy initiation. Events after prolonged loss to follow-up were handled per the analysis plan. Malignancies other than new primary melanoma were not considered RFS events and, except for basal cell carcinoma, were reported as serious adverse events. Tumor tissue from any new primary cancer was collected for biomarker analyses.
- time origin
- Approximately 4 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-tafinlar-e3488bbf
- nct id
- NCT01682083
- outcome key
- om-0002
- source section id
- NCT01682083-om-0002
- source outcome index
- 2
- endpoint
- Percentage of Participants With Overall Survival (OS) Events
- endpoint definition
- Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
- time origin
- Approximately 10 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-tafinlar-e3488bbf
- nct id
- NCT01682083
- outcome key
- om-0003
- source section id
- NCT01682083-om-0003
- source outcome index
- 3
- endpoint
- Overall Survival (OS)
- endpoint definition
- Overall Survival (OS) was defined as the interval from randomization to the date of death, irrespective of the cause of death. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
- time origin
- Approximately 10 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-tafinlar-e3488bbf
- nct id
- NCT01682083
- outcome key
- om-0004
- source section id
- NCT01682083-om-0004
- source outcome index
- 4
- endpoint
- Percentage of Participants With Distant Metastasis-free Survival (DMFS) Events
- endpoint definition
- Distant metastasis-free survival (DMFS) was defined as the time from randomization to the first occurrence of distant metastasis or death, whichever occurred first, if death preceded documented recurrence. Patients who remained alive and free of distant metastasis were censored at the date of their last assessment.
- time origin
- Approximately 4 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-tafinlar-e3488bbf
- nct id
- NCT01682083
- outcome key
- om-0005
- source section id
- NCT01682083-om-0005
- source outcome index
- 5
- endpoint
- Distant Metastasis-free Survival (DMFS)
- endpoint definition
- Distant metastasis-free survival (DMFS) was defined as the time from randomization to the first occurrence of distant metastasis or death, whichever occurred first, if death preceded documented recurrence. Patients who remained alive and free of distant metastasis were censored at the date of their last assessment.
- time origin
- Approximately 4 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
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-tafinlar-e3488bbf
- nct id
- NCT01682083
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Dabrafenib and Trametinib Combination Therapy
- regimen
- Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
- analyzed count
- 438
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01682083-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-tafinlar-e3488bbf
- nct id
- NCT01682083
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Dabrafenib and Trametinib Placebos
- regimen
- Subjects received matching placebos orally for 12 months
- analyzed count
- 432
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01682083-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-tafinlar-e3488bbf
- nct id
- NCT01682083
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Dabrafenib and Trametinib Combination Therapy
- regimen
- Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
- analyzed count
- 438
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01682083-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-tafinlar-e3488bbf
- nct id
- NCT01682083
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Dabrafenib and Trametinib Placebos
- regimen
- Subjects received matching placebos orally for 12 months
- analyzed count
- 432
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01682083-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-tafinlar-e3488bbf
- nct id
- NCT01682083
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Dabrafenib and Trametinib Combination Therapy
- regimen
- Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
- analyzed count
- 438
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01682083-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-tafinlar-e3488bbf
- nct id
- NCT01682083
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Dabrafenib and Trametinib Placebos
- regimen
- Subjects received matching placebos orally for 12 months
- analyzed count
- 432
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01682083-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-tafinlar-e3488bbf
- nct id
- NCT01682083
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Dabrafenib and Trametinib Combination Therapy
- regimen
- Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
- analyzed count
- 438
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01682083-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-tafinlar-e3488bbf
- nct id
- NCT01682083
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Dabrafenib and Trametinib Placebos
- regimen
- Subjects received matching placebos orally for 12 months
- analyzed count
- 432
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01682083-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-tafinlar-e3488bbf
- nct id
- NCT01682083
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Dabrafenib and Trametinib Combination Therapy
- regimen
- Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
- analyzed count
- 438
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01682083-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-tafinlar-e3488bbf
- nct id
- NCT01682083
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Dabrafenib and Trametinib Placebos
- regimen
- Subjects received matching placebos orally for 12 months
- analyzed count
- 432
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01682083-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-tafinlar-e3488bbf
- nct id
- NCT01682083
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Dabrafenib and Trametinib Combination Therapy
- regimen
- Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
- analyzed count
- 438
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01682083-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-tafinlar-e3488bbf
- nct id
- NCT01682083
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Dabrafenib and Trametinib Placebos
- regimen
- Subjects received matching placebos orally for 12 months
- analyzed count
- 432
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01682083-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-tafinlar-e3488bbf
- nct id
- NCT01682083
- harm key
- EG000
- source section id
- NCT01682083-ae
- event group key
- EG000
- event group label
- Dabrafenib + Trametinib Combination Therapy
- serious affected
- 155
- serious at risk
- 435
- other affected
- 414
- other at risk
- 435
- frequency threshold
- 5
- collection period
- Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days post-treat follow-up, assessed up to approximately 12 months. Deaths were recorded from study start date until end of survival follow-up phase (end of study), assessed up to approximately 126 months.
- event definition
- Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the 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-tafinlar-e3488bbf
- nct id
- NCT01682083
- harm key
- EG001
- source section id
- NCT01682083-ae
- event group key
- EG001
- event group label
- Dabrafenib and Trametinib Placebos
- serious affected
- 44
- serious at risk
- 432
- other affected
- 343
- other at risk
- 432
- frequency threshold
- 5
- collection period
- Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days post-treat follow-up, assessed up to approximately 12 months. Deaths were recorded from study start date until end of survival follow-up phase (end of study), assessed up to approximately 126 months.
- event definition
- Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the 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-tafinlar-e3488bbf
- nct id
- NCT01682083
- harm key
- EG002
- source section id
- NCT01682083-ae
- event group key
- EG002
- event group label
- Dabrafenib + Trametinib Combination Therapy (Post-treatment)
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 5
- collection period
- Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days post-treat follow-up, assessed up to approximately 12 months. Deaths were recorded from study start date until end of survival follow-up phase (end of study), assessed up to approximately 126 months.
- event definition
- Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the 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-tafinlar-e3488bbf
- nct id
- NCT01682083
- harm key
- EG003
- source section id
- NCT01682083-ae
- event group key
- EG003
- event group label
- Dabrafenib and Trametinib Placebos (Post-treatment)
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 5
- collection period
- Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days post-treat follow-up, assessed up to approximately 12 months. Deaths were recorded from study start date until end of survival follow-up phase (end of study), assessed up to approximately 126 months.
- event definition
- Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the 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