Trial · NCT03551626
Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes
NCT03551626, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2024-03-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes. Trials, record NCT03551626. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03551626
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes
- NCT number
- NCT03551626
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 552 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Malignant Melanoma
- Interventions
- Dabrafenib, Trametinib
- First posted
- 2018-06-11
- Last updated
- 2025-04-29
- Other registries' IDs
- eudract:2018-000168-27
- Results first posted
- 2024-03-18
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite Rate of Pyrexia Related Events | Baseline up to 12 months | The composite rate of pyrexia related events was calculated as the total number of participants experiencing at least one of the three components of the composite endpoint (i.e., grade 3/4 pyrexia, hospitalization due to pyrexia, or permanent treatment discontinuation due to pyrexia), divided by the total number of participants treated in the study and multiplied by 100. Pyrexia is defined as fever ≥ 38 °C. Pyrexia events were graded by the investigator using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Life-threatening) and Grade 5 (Death) |
| Secondary | Relapse Free Survival (RFS) Rate | At 12 and 24 months | RFS is defined as the time from the date of first dose of the study treatment to the date of the first documented disease recurrence or death due to any cause whichever comes first. Treatment emergent malignancies other than second melanomas were not considered as events. RFS rate is the estimated percent probability that a patient will remain event-free up to the specified time point. RFS rate was obtained from the Kaplan-Meier survival estimates. RFS was censored if no RFS event was observed before the first to occur between: (i) the analysis cut-off date, and (ii) the date when a new anti-cancer therapy is started. The censoring date was the date of the last adequate tumor assessment prior to data cut-off date/start of new anti-cancer therapy date. |
| Secondary | Overall Survival (OS) Rate | At 12 and 24 months | OS is defined as the time from date of the first dose of study medication to date of death due to any cause, whichever comes first. If a patient was not known to have died, then OS rate is the estimated probability that a patient will remain event-free up to the specified time point. OS rate was obtained from the Kaplan-Meier survival estimates. OS was censored at the last contact date when the patient was known to be alive (on or before the cut-off date). |
| Secondary | Percentage of Participants Who Required Management of Pyrexia | Baseline up to 12 months | Percentage of patients who experienced pyrexia and required intervention including hospitalizations, concomitant medications, and study treatment modifications (dose reductions, permanent discontinuations and/or interruptions) due to pyrexia. Pyrexia is defined as fever ≥ 38 °C |
| Secondary | Percentage of Participants Who Permanently Discontinued Treatment Due to Any Adverse Event (AE) | Baseline up to 12 months | Percentage of participants who permanently discontinued treatment due to any AE during treatment. An AE is any untoward medical occurrence (e.g., any unfavorable and unintended sign, symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. |
| Secondary | Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) | Baseline up to 24 months | The FACT-M is a questionnaire that assesses participant health-related quality of life. It includes a melanoma specific (FACT-M MS) subscale that consists in 16 items related to signs, symptoms, physical/social activities most relevant to participants with advanced-stage melanoma. Each item ranges from 0 (not at all) to 4 (very much). FACT-M MS score ranges from 0 to 64, with higher score indicating better quality of life. If a patient discontinued the study treatment at Month 1 or Month 2, then the follow-up assessments started at Month 3 follow-up and continued until Month 24 follow-up or at withdrawal, lost to follow-up, death, or end of study. If a patient discontinued the study treatment from Month 3 through Month 5, the follow-up assessments started at Month 6 follow-up. If a patient discontinued from Month 6 through Month 11, the follow-up assessments started from Month 12 follow-up. For patients who completed treatment, the follow-up assessments started from Month 15 follow-up |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Composite Rate of Pyrexia Related Events | Baseline up to 12 months | All subjects who received at least one dose of any study treatment | Percentage of participants | NUMBER |
| SECONDARY | Relapse Free Survival (RFS) Rate | At 12 and 24 months | All subjects who received at least one dose of any study treatment | Percent probability | NUMBER |
| SECONDARY | Overall Survival (OS) Rate | At 12 and 24 months | All subjects who received at least one dose of any study treatment | Percent probability | NUMBER |
| SECONDARY | Percentage of Participants Who Required Management of Pyrexia | Baseline up to 12 months | All subjects who received at least one dose of any study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Who Permanently Discontinued Treatment Due to Any Adverse Event (AE) | Baseline up to 12 months | All subjects who received at least one dose of any study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) | Baseline up to 24 months | All subjects who received at least one dose of any study treatment. Number analyzed represents participants with data available at the specified data points | Score on a scale | MEAN |
| POST_HOC | All Collected Deaths | On-treatment: from first study treatment to 30 days after last dose of study treatment, up to 13 months. Post-treatment: From day 31 after last study treatment up to approximately 39 months | All subjects who received at least one dose of any study treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Composite Rate of Pyrexia Related Events | Dabrafenib+Trametinib | 7.6 | 95% Confidence Interval 5.5 to 10.1 | Percentage of participants | |
| Relapse Free Survival (RFS) Rate | Dabrafenib+Trametinib | 12 months | 91.7 | 95% Confidence Interval 89.0 to 93.8 | Percent probability |
| Relapse Free Survival (RFS) Rate | Dabrafenib+Trametinib | 24 months | 57.5 | 95% Confidence Interval 48.9 to 65.2 | Percent probability |
| Overall Survival (OS) Rate | Dabrafenib+Trametinib | 12 months | 99.1 | 95% Confidence Interval 97.8 to 99.6 | Percent probability |
| Overall Survival (OS) Rate | Dabrafenib+Trametinib | 24 months | 92.6 | 95% Confidence Interval 90.0 to 94.5 | Percent probability |
| Percentage of Participants Who Required Management of Pyrexia | Dabrafenib+Trametinib | Hospitalizations due to pyrexia | 24 | Participants | |
| Percentage of Participants Who Required Management of Pyrexia | Dabrafenib+Trametinib | Concomitant medications due to pyrexia | 210 | Participants | |
| Percentage of Participants Who Required Management of Pyrexia | Dabrafenib+Trametinib | Permanent discontinuation of dabrafenib and trametinib (both drugs together) due to pyrexia | 13 | Participants | |
| Percentage of Participants Who Required Management of Pyrexia | Dabrafenib+Trametinib | Reduction of dabrafenib and trametinib (both drugs together) due to pyrexia | 29 | Participants | |
| Percentage of Participants Who Required Management of Pyrexia | Dabrafenib+Trametinib | Interruption of dabrafenib and trametinib (both drugs together) due to pyrexia | 339 | Participants |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dabrafenib+Trametinib | 552 | |
| Overall Study | COMPLETED | Dabrafenib+Trametinib | 425 | |
| Overall Study | NOT COMPLETED | Dabrafenib+Trametinib | 127 |
Source ClinicalTrials.gov
Adverse events256
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 (On-treatment) | 44 | 552 | |
| other | Neutropenia | Blood and lymphatic system disorders | Dabrafenib+Trametinib (Post-treatment Follow-up) | 0 | ||
| other | Abdominal pain | Gastrointestinal disorders | Dabrafenib+Trametinib (On-treatment) | 44 | 552 | |
| other | Abdominal pain | Gastrointestinal disorders | Dabrafenib+Trametinib (Post-treatment Follow-up) | 0 | ||
| other | Abdominal pain upper | Gastrointestinal disorders | Dabrafenib+Trametinib (On-treatment) | 30 | 552 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Dabrafenib+Trametinib (Post-treatment Follow-up) | 0 | ||
| other | Constipation | Gastrointestinal disorders | Dabrafenib+Trametinib (On-treatment) | 46 | 552 | |
| other | Constipation | Gastrointestinal disorders | Dabrafenib+Trametinib (Post-treatment Follow-up) | 0 | ||
| other | Diarrhoea | Gastrointestinal disorders | Dabrafenib+Trametinib (On-treatment) | 149 | 552 | |
| other | Diarrhoea | Gastrointestinal disorders | Dabrafenib+Trametinib (Post-treatment Follow-up) | 0 |
1 to 10 of 256Source ClinicalTrials.gov
See all 256 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dabrafenib+Trametinib (On-treatment) | 1 | 552 |
| Total, all-cause mortality | Dabrafenib+Trametinib (Post-treatment Follow-up) | 47 | 537 |
| Total, other adverse events | Dabrafenib+Trametinib (On-treatment) | 526 | 552 |
| Total, other adverse events | Dabrafenib+Trametinib (Post-treatment Follow-up) | 0 | 0 |
| Total, serious adverse events | Dabrafenib+Trametinib (On-treatment) | 121 | 552 |
| Total, serious adverse events | Dabrafenib+Trametinib (Post-treatment Follow-up) | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35042070 | DERIVED |
Source PubMed
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 (On-treatment) vs Dabrafenib+Trametinib (Post-treatment Follow-up): deaths from any cause |
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/NCT03551626
GET https://conductscience.org/api/trials/v1/NCT03551626/results?page=2