Trial · NCT02083354
Study to Investigate the Objective Response Rate of Dabrafenib in Combination With Trametinib in Subjects With BRAF V600 Mutation-Positive Melanoma
NCT02083354, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2021-03-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Investigate the Objective Response Rate of Dabrafenib in Combination With Trametinib in Subjects With BRAF V600 Mutation-Positive Melanoma. Trials, record NCT02083354. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02083354
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Investigate the Objective Response Rate of Dabrafenib in Combination With Trametinib in Subjects With BRAF V600 Mutation-Positive Melanoma
- NCT number
- NCT02083354
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 77 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Cancer, Melanoma
- Interventions
- Dabrafenib, Trametinib
- First posted
- 2014-03-11
- Last updated
- 2022-02-01
- Results first posted
- 2021-03-17
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Up to 35 months | To determine ORR of dabrafenib in combination with trametinib in subjects with BRAF V600 mutation-positive, unresectable or metastatic melanoma. ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and as assessed by the investigator. |
| Secondary | Progression-free Survival (PFS) - Median | Up to 36 months | PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause |
| Secondary | Progression-free Survival (PFS) | Up to 36 months | PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause. Censored, follow-up ongoing - These subjects show as ongoing in the clinical database even though no subjects are currently ongoing, as no changes to the data were permitted after 30-Jun-2019 due to local regulations in China. |
| Secondary | Duration of Response (DOR) - Estimate for Duration of Response - Median | Up to 36 months | Duration of response is defined as the time from first documented evidence of complete response (CR) or partial response (PR) until the earliest date of documented radiological progression or death due to any cause among subjects who achieved a confirmed CR or PR. |
| Secondary | Duration of Response (DOR) | Up to 36 months | Duration of response is defined as the time from first documented evidence of complete response (CR) or partial response (PR) until the earliest date of documented radiological progression or death due to any cause among subjects who achieved a confirmed CR or PR. Censored, follow-up ongoing - These subjects show as ongoing in the clinical database even though no subjects are currently ongoing, as no changes to the data were permitted after 30-Jun-2019 due to local regulations in China. |
| Secondary | Overall Survival (OS) - Median | Approximately 5 years | OS is defined as the interval from first dose of study treatment to the date of death, irrespective of the cause of death; subjects still alive will be censored at the date of the last contact |
| Secondary | Overall Survival (OS) | Approximately 5 years | OS is defined as the interval from first dose of study treatment to the date of death, irrespective of the cause of death; subjects still alive will be censored at the date of the last contact. Censored, follow-up ongoing - These subjects show as ongoing in the clinical database even though no subjects are currently ongoing, as no changes to the data were permitted after 30-Jun-2019 due to local regulations in China. |
| Secondary | Number of Participants With Adverse Events | Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 51 months (for both dabrafenib and also Rametinib). | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. |
| Secondary | Population Pharmacokinetics of Dabrafenib - Cmax | Day 1 and Day 15 | Cmax is the maximum peak concentration. |
| Secondary | Population Pharmacokinetics of Dabrafenib - Tmax | Day 1 and Day 15 | Tmax is Time to Cmax (maximum peak concentration). |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 registered outcomesOutcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | Up to 35 months | Full Analysis Set | Percentage of Participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) - Median | Up to 36 months | Full analysis set | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Up to 36 months | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) - Estimate for Duration of Response - Median | Up to 36 months | Full analysis set, for participants who achieved CR or PR. | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | Up to 36 months | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) - Median | Approximately 5 years | Full analysis set | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Approximately 5 years | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events | Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 51 months (for both dabrafenib and also Rametinib). | Safety set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Population Pharmacokinetics of Dabrafenib - Cmax | Day 1 and Day 15 | PK analysis set | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Population Pharmacokinetics of Dabrafenib - Tmax | Day 1 and Day 15 | PK analysis set | hr | MEDIAN |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 outcomesResults by group73
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Arm 1 | 61 | 95% Confidence Interval 49.2 to 72.0 | Percentage of Participants | |
| Progression-free Survival (PFS) - Median | Arm 1 | 9.17 | 95% Confidence Interval 7.26 to 12.88 | months | |
| Progression-free Survival (PFS) | Arm 1 | Progressive Disease (PD) (event) | 52 | Participants | |
| Progression-free Survival (PFS) | Arm 1 | Died (event) | 4 | Participants | |
| Progression-free Survival (PFS) | Arm 1 | Censored, follow-up ended | 10 | Participants | |
| Progression-free Survival (PFS) | Arm 1 | Censored, follow-up ongoing | 11 | Participants | |
| Duration of Response (DOR) - Estimate for Duration of Response - Median | Arm 1 | 12.65 | 95% Confidence Interval 5.62 to 25.23 | Months | |
| Duration of Response (DOR) | Arm 1 | PFS - Disease Progression | 27 | Participants | |
| Duration of Response (DOR) | Arm 1 | PFS - Death | 2 | Participants | |
| Duration of Response (DOR) | Arm 1 | PFS - Censored, follow-up ended | 9 | Participants |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1 | 77 | |
| Overall Study | COMPLETED | Arm 1 | 13 | |
| Overall Study | NOT COMPLETED | Arm 1 | 64 |
Source ClinicalTrials.gov
Adverse events78
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 | All Patients | 37 | 77 | |
| other | Abdominal distension | Gastrointestinal disorders | All Patients | 4 | 77 | |
| other | Constipation | Gastrointestinal disorders | All Patients | 13 | 77 | |
| other | Diarrhoea | Gastrointestinal disorders | All Patients | 10 | 77 | |
| other | Mouth ulceration | Gastrointestinal disorders | All Patients | 4 | 77 | |
| other | Nausea | Gastrointestinal disorders | All Patients | 22 | 77 | |
| other | Vomiting | Gastrointestinal disorders | All Patients | 18 | 77 | |
| other | Asthenia | General disorders | All Patients | 5 | 77 | |
| other | Chest discomfort | General disorders | All Patients | 4 | 77 | |
| other | Chest pain | General disorders | All Patients | 5 | 77 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Patients | 16 | 77 |
| Total, other adverse events | All Patients | 75 | 77 |
| Total, serious adverse events | All Patients | 18 | 77 |
Source ClinicalTrials.gov
Papers2
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/NCT02083354
GET https://conductscience.org/api/trials/v1/NCT02083354/registered?page=2