The Absolute Effect / Oncology Evidence / Evidence Index
COMBI-AD
After complete resection of stage III BRAF V600-mutant melanoma, does adjuvant dabrafenib plus trametinib improve recurrence-free and distant-metastasis-free survival over placebo?
Registry: NCT01682083 · Evidence reviewed 9 November 2026 · Aliases and follow-up publications consolidated.
Phase III double-blind placebo-controlled; n=870.Primary-source evidence summaryStudy design, population and eligibility
Phase III double-blind placebo-controlled; n=870.
Completely resected stage III BRAF V600E/K melanoma.
Treatment and comparator
Intervention: Dabrafenib + trametinib for 12 months.
Comparator: Placebo.
Endpoints
RFS primary; DMFS and OS secondary.
Key efficacy and clinical outcomes
Long-term RFS HR .52 and DMFS HR .56; final OS estimate HR .80, not statistically significant at prespecified threshold.
Source-reported outcome visualization
Values are reproduced from the cited report; bars are scaled within this figure. Resected stage III BRAF V600-mutant melanoma
Median survival and hazard ratios are not fixed-time event risks; NNT is not inferred from them.
Toxicity and treatment burden
Pyrexia, fatigue, rash, nausea; cardiomyopathy and ocular toxicity uncommon but important.
Absolute effect and NNT/NNH
Robust RFS/DMFS benefit; overall OS difference did not reach conventional significance.
NNT/NNH is not calculated unless a directly reported, comparable fixed-time risk difference supports it. Median survival and hazard ratios alone do not provide an NNT.
Critical interpretation and limitations
Robust RFS/DMFS benefit; overall OS difference did not reach conventional significance.
This page is an evidence summary, not a substitute for multidisciplinary assessment or patient-specific decision-making.
Current-practice context
Review date: 9 November 2026. Primary publication and selected follow-up sources were reviewed. Full disease-specific guideline, regulatory-label and sequencing audit remains pending; verify current local recommendations and biomarker eligibility before clinical application.