Trial · NCT01584648
A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma
NCT01584648, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2014-08-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma. Trials, record NCT01584648. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01584648
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma
- NCT number
- NCT01584648
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 423 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Melanoma
- Interventions
- Dabrafenib, Trametinib, Trametinib placebo
- First posted
- 2012-04-25
- Last updated
- 2021-02-17
- Other registries' IDs
- eudract:2011-006087-49
- Results first posted
- 2014-08-15
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | PFS is defined as the interval between the date of randomization and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm. The appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation, was also included as PD. Participants who received anti-cancer therapy prior to the date of documented events, were censored at the last adequate assessment prior to the initiation of therapy. If the participant did not have documented progression or death, PFS was censored at the date of the last adequate assessment. |
| Secondary | Overall Survival (OS) | From the date of randomization until date of death due to any cause (up to approximately 6 years) | OS is defined as the interval of time between the date of randomization and the date of death due to any cause. For the participants who did not die, overall survival was censored at the date of last contact. |
| Secondary | Objective Response Rate (ORR) as Assessed by the Investigator | From randomization until the first documented complete response or partial response (up to approximately 6 years) | ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR). A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all target lesions and any pathological lymph nodes must have a short axis of \<10 mm and the disappearance of all non-target lesions) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm). Only descriptive analysis performed. |
| Secondary | Duration of Response (DoR) | From the time of the first documented response (CR or PR) until disease progression (up to approximately 6 years) | Duration of response is defined as the time from the first documented complete response (CR: the disappearance of all target lesions and any pathological lymph nodes must have a short axis of \<10 mm and the disappearance of all non-target lesions) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm) until disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5mm or the appearance of one or more new lesions, or the worsening of non target lesions significant enough to require study treatment discontinuation. PD was based on the radiological evidence by investigator. Only descriptive analysis performed. |
| Secondary | Trametinib Pharmacokinetic Concentrations | Week 8 (0, 1-3, 4-6 hours post dose), Weeks 16 and 24 (0 hour pre-dose) | Blood samples were collected for Pharmacokinetic (PK) analysis in all participants. Three blood samples were collected at Week 8: pre-dose, 1-3 hours post dose, and 4-6 hours post dose. One pre-dose blood sample was obtained at Weeks 16 and 24. Only descriptive analysis performed. |
| Secondary | Dabrafenib and Dabrafenib Metabolites (Hydroxy-, Carboxy- and Desmethyl-Dabrafenib) Concentrations | Week 8 (0, 1-3, 4-6 hours post dose), Weeks 16 and 24 (0 hour pre-dose) | Blood samples were collected for PK analysis in all participants. Three blood samples were collected at Week 8: pre-dose, 1-3 hours post dose, and 4-6 hours post dose. One pre-dose blood sample was obtained at Weeks 16 and 24. Plasma concentrations of Dabrafenib (GSK2118436) and its metabolites (Hydroxy-Dabrafenib (GSK2285403), Carboxy-Dabrafenib (GSK2298683), and Desmethyl-Dabrafenib (GSK2167542)) were determined using the currently approved analytical methodology. Only descriptive analysis performed. |
| Secondary | Number of Participants With Adverse Events and Serious Adverse Events | From the time the first dose of study treatment administered until 30 days after discontinuation of study treatment (up to approximately 6 years). | Analysis of absolute and relative frequencies for Adverse Event (AE) and Serious Adverse Event (SAE) by primary System Organ Class (SOC) to characterize the safety of dabrafenib and trametinib combination therapy through the monitoring of relevant clinical and laboratory safety parameters. In addition, new malignancies and AEs possibly related to study treatment were collected even if they occurred more than 30 days post-treatment. Only descriptive analysis performed. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 was considered. | Months | MEDIAN |
| SECONDARY | 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 was considered. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) 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 was considered. Only participants with measurable disease at Baseline per RECIST were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DoR) | From the time of the first documented response (CR or PR) until disease progression (up to approximately 6 years) | ITT population. Only those participants with a confirmed CR or PR were analyzed (with or without measurabe disease at Baseline). | Months | MEDIAN |
| SECONDARY | Trametinib Pharmacokinetic Concentrations | Week 8 (0, 1-3, 4-6 hours post dose), Weeks 16 and 24 (0 hour pre-dose) | Pharmacokinetic (PK) Population: all participants included in the safety population for whom a PK sample was obtained and analyzed. Only participants with data available at the specified time points were analyzed. | Nanogram per Milliliter (ng/mL) | MEAN |
| SECONDARY | Dabrafenib and Dabrafenib Metabolites (Hydroxy-, Carboxy- and Desmethyl-Dabrafenib) Concentrations | Week 8 (0, 1-3, 4-6 hours post dose), Weeks 16 and 24 (0 hour pre-dose) | PK Population. | Nanogram per Milliliter (ng/mL) | MEAN |
| SECONDARY | Number of Participants With Adverse Events and Serious Adverse Events | From the time the first dose of study treatment administered until 30 days after discontinuation of study treatment (up to approximately 6 years). | Safety Population: all randomized participants who received at least one dose of study medication and were based on the actual treatment received if this differed from that to which the participant was randomized. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | All Collected Deaths | up to 28 days before Day 1 (Screening), up to 77.4 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 group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) as Assessed by the Investigator | Dabrafenib + Trametinib | 10.2 | 95% Confidence Interval 8.1 to 12.8 | Months | |
| Progression-Free Survival (PFS) as Assessed by the Investigator | Dabrafenib + Placebo | 8.8 | 95% Confidence Interval 5.9 to 9.3 | Months | |
| Overall Survival (OS) | Dabrafenib + Trametinib | 25.8 | 95% Confidence Interval 19.2 to 38.2 | Months | |
| Overall Survival (OS) | Dabrafenib + Placebo | 18.7 | 95% Confidence Interval 15.2 to 23.1 | Months | |
| Objective Response Rate (ORR) as Assessed by the Investigator | Dabrafenib + Trametinib | 146 | Participants | ||
| Objective Response Rate (ORR) as Assessed by the Investigator | Dabrafenib + Placebo | 113 | Participants | ||
| Duration of Response (DoR) | Dabrafenib + Trametinib | 12.9 | 95% Confidence Interval 9.3 to 18.4 | Months | |
| Duration of Response (DoR) | Dabrafenib + Placebo | 10.2 | 95% Confidence Interval 8.3 to 13.8 | Months | |
| Trametinib Pharmacokinetic Concentrations | Dabrafenib + Trametinib | Week 8, pre-dose | 9.9209 | Standard Deviation 3.86587 | Nanogram per Milliliter (ng/mL) |
| Trametinib Pharmacokinetic Concentrations | Dabrafenib + Placebo | Week 8, pre-dose | 0.0000 | Standard Deviation 0.00000 | Nanogram per Milliliter (ng/mL) |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dabrafenib + Trametinib | 211 | |
| Overall Study | STARTED | Dabrafenib + Placebo | 212 | |
| Overall Study | Safety Set | Dabrafenib + Trametinib | 209 | |
| Overall Study | Safety Set | Dabrafenib + Placebo | 211 | |
| Overall Study | Crossover Population | Dabrafenib + Trametinib | 0 | |
| Overall Study | Crossover Population | Dabrafenib + Placebo | 28 | |
| Overall Study | COMPLETED | Dabrafenib + Trametinib | 0 | |
| Overall Study | COMPLETED | Dabrafenib + Placebo | 0 | |
| Overall Study | NOT COMPLETED | Dabrafenib + Trametinib | 211 | |
| Overall Study | NOT COMPLETED | Dabrafenib + Placebo | 212 |
Source ClinicalTrials.gov
Adverse events1,052
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 + Trametinib | 16 | 209 | |
| other | Anaemia | Blood and lymphatic system disorders | Dabrafenib + Placebo | 22 | 211 | |
| other | Anaemia | Blood and lymphatic system disorders | Crossover Dabrafenib + Trametinib | 3 | 28 | |
| other | Anaemia | Blood and lymphatic system disorders | All Patients | 38 | 420 | |
| other | Leukopenia | Blood and lymphatic system disorders | Dabrafenib + Trametinib | 7 | 209 | |
| other | Leukopenia | Blood and lymphatic system disorders | Dabrafenib + Placebo | 1 | 211 | |
| other | Leukopenia | Blood and lymphatic system disorders | Crossover Dabrafenib + Trametinib | 2 | 28 | |
| other | Leukopenia | Blood and lymphatic system disorders | All Patients | 10 | 420 | |
| other | Neutropenia | Blood and lymphatic system disorders | Dabrafenib + Trametinib | 20 | 209 | |
| other | Neutropenia | Blood and lymphatic system disorders | Dabrafenib + Placebo | 5 | 211 |
1 to 10 of 1,052Source ClinicalTrials.gov
See all 1,052 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dabrafenib + Trametinib | 135 | 209 |
| Total, all-cause mortality | Dabrafenib + Placebo | 146 | 211 |
| Total, all-cause mortality | Crossover Dabrafenib + Trametinib | 5 | 28 |
| Total, all-cause mortality | All Patients | 286 | 420 |
| Total, other adverse events | Dabrafenib + Trametinib | 194 | 209 |
| Total, other adverse events | Dabrafenib + Placebo | 200 | 211 |
| Total, other adverse events | Crossover Dabrafenib + Trametinib | 23 | 28 |
| Total, other adverse events | All Patients | 394 | 420 |
| Total, serious adverse events | Dabrafenib + Trametinib | 100 | 209 |
| Total, serious adverse events | Dabrafenib + Placebo | 80 | 211 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers8
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dabrafenib + Trametinib vs Dabrafenib + Placebo: Objective Response Rate (ORR) as Assessed by the Investigator |
Source 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/NCT01584648
GET https://conductscience.org/api/trials/v1/NCT01584648/results?page=2