Trial · NCT01682083
Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).
NCT01682083, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2018-09-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD). Trials, record NCT01682083. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01682083
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).
- NCT number
- NCT01682083
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 870 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Melanoma
- Interventions
- Dabrafenib, Trametinib, Placebos
- First posted
- 2012-09-10
- Last updated
- 2026-04-21
- Other registries' IDs
- eudract:2012-001266-15
- Results first posted
- 2018-09-26
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Relapse-free Survival (RFS) Events | Approximately 4 years | 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. |
| Primary | Relapse-free Survival (RFS) | Approximately 4 years | 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. |
| Secondary | Percentage of Participants With Overall Survival (OS) Events | Approximately 10 years | Censoring was performed using the date of last known contact for those who were alive at the time of analysis. |
| Secondary | Overall Survival (OS) | Approximately 10 years | 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. |
| Secondary | Percentage of Participants With Distant Metastasis-free Survival (DMFS) Events | Approximately 4 years | 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. |
| Secondary | Distant Metastasis-free Survival (DMFS) | Approximately 4 years | 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. |
| Secondary | Percentage of Participants With Freedom From Relapse (FFR) Events | Approximately 4 years | The first appearance of local/distant metastasis or mortality due to disease recurrence or toxicity were used as events. Censoring was performed using the date of last assessment for those who were alive without local/distant metastasis or new primary melanoma at the time of analysis. FFR was censored if patients died from causes other than melanoma or treatment-related toxicity at the date of death. |
| Secondary | Freedom From Relapse (FFR) | Approximately 4 years | Freedom from relapse (FFR) was defined as the interval from randomization to local or distant recurrence with censoring of patients dying from causes other than melanoma or treatment -related toxicity at the date of death. The first appearance of local/distant metastasis or mortality due to disease recurrence or toxicity were used as events. Censoring was performed using the date of last assessment for those who were alive without local/distant metastasis or new primary melanoma at the time of analysis. FFR was censored if patients died from causes other than melanoma or treatment-related toxicity at the date of death. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Relapse-free Survival (RFS) | Approximately 3.5 years | Intent-to-Treat (ITT) Population | Participants with events | NUMBER |
| SECONDARY | Overall Survival | approximately 3.5 years | ITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Distant Metastasis-free Survival | approximately 3.5 years | ITT population | Participants with events | NUMBER |
| SECONDARY | Freedom From Relapse | approximately 3.5 years | ITT population | Participants with events | NUMBER |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Relapse-free Survival (RFS) | Dabrafenib and Trametinib Combination Therapy | Relapsed (event) | 163 | Participants with events | |
| Relapse-free Survival (RFS) | Dabrafenib and Trametinib Placebos | Relapsed (event) | 247 | Participants with events | |
| Relapse-free Survival (RFS) | Dabrafenib and Trametinib Combination Therapy | Died | 3 | Participants with events | |
| Relapse-free Survival (RFS) | Dabrafenib and Trametinib Placebos | Died | 1 | Participants with events | |
| Relapse-free Survival (RFS) | Dabrafenib and Trametinib Combination Therapy | Censored, follow-up ended | 43 | Participants with events | |
| Relapse-free Survival (RFS) | Dabrafenib and Trametinib Placebos | Censored, follow-up ended | 35 | Participants with events | |
| Relapse-free Survival (RFS) | Dabrafenib and Trametinib Combination Therapy | Censored, follow-up ongoing | 229 | Participants with events | |
| Relapse-free Survival (RFS) | Dabrafenib and Trametinib Placebos | Censored, follow-up ongoing | 149 | Participants with events | |
| Overall Survival | Dabrafenib and Trametinib Combination Therapy | Died (event) | 60 | Participants | |
| Overall Survival | Dabrafenib and Trametinib Placebos | Died (event) | 93 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dabrafenib and Trametinib Combination Therapy | 438 | |
| Overall Study | STARTED | Dabrafenib and Trametinib Placebos | 432 | |
| Overall Study | COMPLETED | Dabrafenib and Trametinib Combination Therapy | 331 | |
| Overall Study | COMPLETED | Dabrafenib and Trametinib Placebos | 277 | |
| Overall Study | NOT COMPLETED | Dabrafenib and Trametinib Combination Therapy | 107 | |
| Overall Study | NOT COMPLETED | Dabrafenib and Trametinib Placebos | 155 |
Source ClinicalTrials.gov
Adverse events366
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Dabrafenib + Trametinib Combination Therapy | 34 | 435 | |
| other | Neutropenia | Blood and lymphatic system disorders | Dabrafenib and Trametinib Placebos | 4 | 432 | |
| other | Dry eye | Eye disorders | Dabrafenib + Trametinib Combination Therapy | 22 | 435 | |
| other | Dry eye | Eye disorders | Dabrafenib and Trametinib Placebos | 13 | 432 | |
| other | Vision blurred | Eye disorders | Dabrafenib + Trametinib Combination Therapy | 27 | 435 | |
| other | Vision blurred | Eye disorders | Dabrafenib and Trametinib Placebos | 16 | 432 | |
| other | Abdominal pain | Gastrointestinal disorders | Dabrafenib + Trametinib Combination Therapy | 34 | 435 | |
| other | Abdominal pain | Gastrointestinal disorders | Dabrafenib and Trametinib Placebos | 23 | 432 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Dabrafenib + Trametinib Combination Therapy | 30 | 435 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Dabrafenib and Trametinib Placebos | 27 | 432 |
1 to 10 of 366Source ClinicalTrials.gov
See all 366 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dabrafenib + Trametinib Combination Therapy | 4 | 435 |
| Total, all-cause mortality | Dabrafenib and Trametinib Placebos | 1 | 432 |
| Total, other adverse events | Dabrafenib + Trametinib Combination Therapy | 414 | 435 |
| Total, other adverse events | Dabrafenib and Trametinib Placebos | 340 | 432 |
| Total, serious adverse events | Dabrafenib + Trametinib Combination Therapy | 155 | 435 |
| Total, serious adverse events | Dabrafenib and Trametinib Placebos | 44 | 432 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dabrafenib + Trametinib Combination Therapy vs Dabrafenib and Trametinib Placebos: deaths from any cause | Trial comparisons |
| Dabrafenib + Trametinib Combination Therapy vs Dabrafenib and Trametinib Placebos: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01682083
GET https://conductscience.org/api/trials/v1/NCT01682083/results?page=2