Trial · NCT01006980
A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)
NCT01006980, Phase 3, Completed, Hoffmann-La Roche; results first posted 2011-11-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3). Trials, record NCT01006980. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01006980
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)
- NCT number
- NCT01006980
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 675 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Malignant Melanoma
- Interventions
- Vemurafenib, Dacarbazine
- First posted
- 2009-11-03
- Last updated
- 2016-09-28
- Results first posted
- 2011-11-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3). | An Overall survival event was defined as death due to any cause. The number of participants with overall survival events is reported. |
| Primary | Progression-free Survival | From randomization (initiated January 2010) to December 30 2010. | A progression-free survival (PFS) event was defined as disease progression or death due to any cause. Tumor response (progression) was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria using computed tomography (CT) scans or magnetic resonance imaging (MRI). |
| Secondary | Participants With a Best Overall Response (BOR) of Complete Response or Partial Response | From randomization (initiated January 2010) until December 30, 2010 | BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Participants who never received study treatment and treated participants without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion and no new lesion. |
| Secondary | Duration of Response | From randomization (initiated in January 2010) until December 30, 2010. | Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause. Duration of response was calculated only for participants who had a best overall response of Complete Response or Partial Response and was estimated using the Kaplan-Meier method. |
| Secondary | Time to Confirmed Response | From randomization (initiated January 2010) until December 30, 2010. | Time to response was defined as the time from randomization to confirmed response (complete response or partial response). |
| Secondary | Time to Treatment Failure | approximately 3 years | Treatment failure was defined as a secondary endpoint in the protocol, defined as death, disease progression or premature withdrawal of study treatment. This endpoint was not included in the Statistical analysis plan; therefore no analyses of time to treatment failure were performed. |
| Secondary | Number of Participants With Adverse Events (AEs) | From randomization (initiated January 2010) until December 30, 2010. | The intensity of AEs was graded according to the NCI Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a five-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening and Death). A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution, for example is life-threatening, requires hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or requires intervention to prevent one or other of the outcomes listed above. |
| Secondary | Pre and Post-dose Plasma Vemurafenib Concentration by Study Day | Plasma samples were collected before the morning dose (troughs) and 2-4 hours after the morning dose at the beginning of each cycle (Days 1, 22, 43, 64, 106, 148 and 190). | The pharmacokinetics of vemurafenib were assessed at the beginning of each 21-day cycle using pre-dose and 2-4 hours post-dose sampling. |
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 | Overall Survival | From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3). | The intent-to-treat (ITT) population was defined as all randomized participants, whether or not study treatment was received. The ITT population was analyzed according to the treatment assigned at randomization. Overall survival was assessed on participants randomized at least 15 days prior to the clinical cutoff date of December 30, 2010. | participants | NUMBER |
| PRIMARY | Progression-free Survival | From randomization (initiated January 2010) to December 30 2010. | The analysis population for PFS consisted of all ITT participants randomized by October 27, 2010 (at least 9 weeks prior to the clinical cutoff date of December 30, 2010). The 9-week interval was chosen to allow time for participants to have had their first scheduled post baseline tumor assessment CT scan. | participants | NUMBER |
| SECONDARY | Participants With a Best Overall Response (BOR) of Complete Response or Partial Response | From randomization (initiated January 2010) until December 30, 2010 | The analysis population consisted of all ITT participants randomized by September 22, 2010 (at least 14 weeks prior to the clinical cutoff date of December 30, 2010). The 14-week interval was chosen as it was the minimum time needed to observe a confirmed overall response according to protocol-specified schedule for the first two tumor assessments. | participants | NUMBER |
| SECONDARY | Duration of Response | From randomization (initiated in January 2010) until December 30, 2010. | The analysis population included all participants randomized by September 22, 2010 and with a best overall confirmed response of complete response or partial response. | months | MEDIAN |
| SECONDARY | Time to Confirmed Response | From randomization (initiated January 2010) until December 30, 2010. | The analysis population included all participants randomized by September 22, 2010 and with a best overall confirmed response of complete response or partial response. | months | MEDIAN |
| SECONDARY | Time to Treatment Failure | approximately 3 years | |||
| SECONDARY | Number of Participants With Adverse Events (AEs) | From randomization (initiated January 2010) until December 30, 2010. | The safety population was defined as all treated participants who had at least one on-study assessment. The safety population was analyzed according to the treatment received. | participants | NUMBER |
| SECONDARY | Pre and Post-dose Plasma Vemurafenib Concentration by Study Day | Plasma samples were collected before the morning dose (troughs) and 2-4 hours after the morning dose at the beginning of each cycle (Days 1, 22, 43, 64, 106, 148 and 190). | The pharmacokinetic (PK) analysis population included all participants who received vemurafenib and provided valid PK assessments. The PK population at specific time points varied depending on the availability of confirmed dosing and PK assessment times. n indicates the number of participants with available PK data at each time point. | μg/mL | MEAN |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Vemurafenib | Participants with events | 43 | participants | |
| Overall Survival | Dacarbazine | Participants with events | 75 | participants | |
| Overall Survival | Vemurafenib | Participants without events | 293 | participants | |
| Overall Survival | Dacarbazine | Participants without events | 261 | participants | |
| Progression-free Survival | Vemurafenib | Participants with events | 104 | participants | |
| Progression-free Survival | Dacarbazine | Participants with events | 182 | participants | |
| Progression-free Survival | Vemurafenib | Participants without events | 171 | participants | |
| Progression-free Survival | Dacarbazine | Participants without events | 92 | participants | |
| Participants With a Best Overall Response (BOR) of Complete Response or Partial Response | Vemurafenib | Responders | 106 | participants | |
| Participants With a Best Overall Response (BOR) of Complete Response or Partial Response | Dacarbazine | Responders | 12 | participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Vemurafenib and Dacarbazine | STARTED | Vemurafenib | 337 | |
| Vemurafenib and Dacarbazine | STARTED | Dacarbazine | 338 | |
| Vemurafenib and Dacarbazine | Treated | Vemurafenib | 336 | |
| Vemurafenib and Dacarbazine | Treated | Dacarbazine | 293 | |
| Vemurafenib and Dacarbazine | COMPLETED | Vemurafenib | 0 | |
| Vemurafenib and Dacarbazine | COMPLETED | Dacarbazine | 0 | |
| Vemurafenib and Dacarbazine | NOT COMPLETED | Vemurafenib | 337 | |
| Vemurafenib and Dacarbazine | NOT COMPLETED | Dacarbazine | 338 | |
| Crossover: Dacarbazine to Vemurafenib | STARTED | Vemurafenib | 0 | |
| Crossover: Dacarbazine to Vemurafenib | STARTED | Dacarbazine | 84 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events660
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 | Vemurafenib | 32 | 336 | |
| other | Anaemia | Blood and lymphatic system disorders | Dacarbazine | 22 | 293 | |
| other | Anaemia | Blood and lymphatic system disorders | Vemurafenib After Crossover | 13 | 84 | |
| other | Neutropenia | Blood and lymphatic system disorders | Vemurafenib | 1 | 336 | |
| other | Neutropenia | Blood and lymphatic system disorders | Dacarbazine | 34 | 293 | |
| other | Neutropenia | Blood and lymphatic system disorders | Vemurafenib After Crossover | 0 | 84 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Vemurafenib | 5 | 336 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Dacarbazine | 20 | 293 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Vemurafenib After Crossover | 1 | 84 | |
| other | Abdominal Distension | Gastrointestinal disorders | Vemurafenib | 18 | 336 |
1 to 10 of 660Source ClinicalTrials.gov
See all 660 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vemurafenib | ||
| Total, all-cause mortality | Dacarbazine | ||
| Total, all-cause mortality | Vemurafenib After Crossover | ||
| Total, other adverse events | Vemurafenib | 333 | 336 |
| Total, other adverse events | Dacarbazine | 247 | 293 |
| Total, other adverse events | Vemurafenib After Crossover | 83 | 84 |
| Total, serious adverse events | Vemurafenib | 165 | 336 |
| Total, serious adverse events | Dacarbazine | 52 | 293 |
| Total, serious adverse events | Vemurafenib After Crossover | 44 | 84 |
Source ClinicalTrials.gov
Papers8
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/NCT01006980
GET https://conductscience.org/api/trials/v1/NCT01006980/results?page=2