Trial · NCT01597908
Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma
NCT01597908, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2014-12-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma. Trials, record NCT01597908. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01597908
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma
- NCT number
- NCT01597908
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 704 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Melanoma
- Interventions
- Dabrafenib, Vemurafenib, Trametinib
- First posted
- 2012-05-14
- Last updated
- 2021-02-24
- Other registries' IDs
- eudract:2011-006088-23
- Results first posted
- 2014-12-04
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From the date of randomization until date of death due to any cause (up to approximately 6 years) | 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. |
| Secondary | Progression-Free Survival (PFS), as Assessed by the Investigator | From randomization until the earliest date of disease progression (PD) or death due to any cause (up to approximately 6 years) | 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. |
| Secondary | Overall Response Rate (ORR) During Randomized Phase, as Assessed by the Investigator | From randomization until the first documented complete response or partial response (up to approximately 6 years) | 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. |
| Secondary | Duration of Response (DOR), as Assessed by the Investigator | From the time of the first documented response (CR or PR) until disease progression (up to approximately 6 years) | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From the date of randomization until date of death due to any cause (up to approximately 6 years) | Intent-to-Treat (ITT) Population. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS), as Assessed by the Investigator | From randomization until the earliest date of disease progression (PD) or death due to any cause (up to approximately 6 years) | Intent-to-Treat (ITT) Population. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) During Randomized Phase, as Assessed by the Investigator | From randomization until the first documented complete response or partial response (up to approximately 6 years) | Intent-to-Treat (ITT) Population. Only participants with measurable disease at baseline were included. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR), as Assessed by the Investigator | From the time of the first documented response (CR or PR) until disease progression (up to approximately 6 years) | Intent-to-Treat (ITT) Population. Only participants with confirmed response by RECIST version 1.1 were included. | Months | MEDIAN |
| POST_HOC | All Collected Deaths | up to 28 days before Day 1 (Screening), up to 81.1 months (on-treatment), up to approximately 6 years (study duration) | Clinical database population; all treated patients and patients who died during screening. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Dabrafenib Plus Trametinib | 26.0 | 95% Confidence Interval 22.1 to 33.8 | Months | |
| Overall Survival (OS) | Vemurafenib | 17.8 | 95% Confidence Interval 15.6 to 20.7 | Months | |
| Progression-Free Survival (PFS), as Assessed by the Investigator | Dabrafenib Plus Trametinib | 12.1 | 95% Confidence Interval 9.7 to 14.7 | Months | |
| Progression-Free Survival (PFS), as Assessed by the Investigator | Vemurafenib | 7.3 | 95% Confidence Interval 6.0 to 8.1 | Months | |
| Overall Response Rate (ORR) During Randomized Phase, as Assessed by the Investigator | Dabrafenib Plus Trametinib | 68 | 95% Confidence Interval 62.3 to 72.4 | Percentage of Participants | |
| Overall Response Rate (ORR) During Randomized Phase, as Assessed by the Investigator | Vemurafenib | 53 | 95% Confidence Interval 47.2 to 57.9 | Percentage of Participants | |
| Duration of Response (DOR), as Assessed by the Investigator | Dabrafenib Plus Trametinib | 13.8 | 95% Confidence Interval 11.3 to 18.6 | Months | |
| Duration of Response (DOR), as Assessed by the Investigator | Vemurafenib | 8.5 | 95% Confidence Interval 7.4 to 9.3 | Months | |
| All Collected Deaths | Dabrafenib Plus Trametinib | Pre-treatment deaths | 1 | Participants | |
| All Collected Deaths | Vemurafenib | Pre-treatment deaths | 0 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized Phase | STARTED | Dabrafenib Plus Trametinib | 352 | |
| Randomized Phase | STARTED | Vemurafenib | 352 | |
| Randomized Phase | STARTED | Crossover Dabrafenib Plus Trametinib | 0 | |
| Randomized Phase | Safety Set | Dabrafenib Plus Trametinib | 350 | |
| Randomized Phase | Safety Set | Vemurafenib | 349 | |
| Randomized Phase | Safety Set | Crossover Dabrafenib Plus Trametinib | 0 | |
| Randomized Phase | COMPLETED | Dabrafenib Plus Trametinib | 1 | |
| Randomized Phase | COMPLETED | Vemurafenib | 0 | |
| Randomized Phase | COMPLETED | Crossover Dabrafenib Plus Trametinib | 0 | |
| Randomized Phase | NOT COMPLETED | Dabrafenib Plus Trametinib | 351 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events1,352
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 | Anaemia | Blood and lymphatic system disorders | Dabrafenib Plus Trametinib | 29 | 350 | |
| other | Anaemia | Blood and lymphatic system disorders | Vemurafenib | 20 | 349 | |
| other | Anaemia | Blood and lymphatic system disorders | Crossover Dabrafenib Plus Trametinib | 3 | 34 | |
| other | Anaemia | Blood and lymphatic system disorders | All Patients | 52 | 699 | |
| other | Leukopenia | Blood and lymphatic system disorders | Dabrafenib Plus Trametinib | 17 | 350 | |
| other | Leukopenia | Blood and lymphatic system disorders | Vemurafenib | 7 | 349 | |
| other | Leukopenia | Blood and lymphatic system disorders | Crossover Dabrafenib Plus Trametinib | 6 | 34 | |
| other | Leukopenia | Blood and lymphatic system disorders | All Patients | 29 | 699 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Dabrafenib Plus Trametinib | 9 | 350 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Vemurafenib | 9 | 349 |
1 to 10 of 1,352Source ClinicalTrials.gov
See all 1,352 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dabrafenib Plus Trametinib | 216 | 350 |
| Total, all-cause mortality | Vemurafenib | 238 | 349 |
| Total, all-cause mortality | Crossover Dabrafenib Plus Trametinib | 11 | 34 |
| Total, all-cause mortality | All Patients | 465 | 699 |
| Total, other adverse events | Dabrafenib Plus Trametinib | 338 | 350 |
| Total, other adverse events | Vemurafenib | 341 | 349 |
| Total, other adverse events | Crossover Dabrafenib Plus Trametinib | 32 | 34 |
| Total, other adverse events | All Patients | 679 | 699 |
| Total, serious adverse events | Dabrafenib Plus Trametinib | 172 | 350 |
| Total, serious adverse events | Vemurafenib | 139 | 349 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01597908
GET https://conductscience.org/api/trials/v1/NCT01597908/flow?page=2