Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma
NCT01909453 · COLUMBUS Phase 3Completed
- Lead sponsor
- Pfizer (Industry)
- Enrollment
- 921 (actual)
- Start date
- 12 Sep 2013
- Primary completion
- 9 Nov 2016 (actual)
- Study completion
- 3 Sep 2024
- Last update posted
- 27 Feb 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- None
- Arms
- 4
Interventions
- LGX818 Drug
- MEK162 Drug
- vemurafenib Drug
Conditions and primary outcome
- Melanoma
Primary outcome
Part 1: Progression Free Survival (PFS) by BIRC in Combo 450 Group as Compared to Vemurafenib Group (From randomization until documented disease progression (PD), initiation of new anti-cancer therapy, censoring date or death, whichever occurred first (up to 29 months)); Part 1: PFS by BIRC in Combo 450 Group as Compared to LGX818 Group (From randomization until documented PD, initiation of new anti-cancer therapy, censoring date or death, whichever occurred first (up to 29 months), excluding Part 1: LGX818 300 mg group; up to 35 months for Part 1: LGX 300 mg group)
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT01909453 (opens in a new tab)· Licence: public-domain
First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25
Primary outcomes with a statistical analysis
No primary outcome with a statistical analysis is posted for this study.
Serious adverse events
Time frame: Baseline up to 30 days from last dose of study drug (P1: up to 117.8 M for LGX818+MEK162 [combo 450]; up to 111.4 M for LGX818 300mg; up to 110.5 M for Vemurafenib 960mg; P2: up to 106.3 M for LGX818+MEK162 45mg [combo 300]; up to 98.4 M for LGX818 300mg)
| Group | Affected | At risk |
|---|---|---|
| Part 2: LGX818 300 mg QD +MEK162 45 mg BID (Combo 300) | 98 | 257 |
| Part 1: LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) | 84 | 192 |
| Part 1: LGX818 300 mg | 71 | 192 |
| Part 2: LGX818 300 mg | 31 | 84 |
| Part 1: Vemurafenib 960 mg BID | 78 | 186 |
Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
9 on PubMedContribution of MEK Inhibition to BRAF/MEK Inhibitor Combination Treatment of BRAF-Mutant Melanoma: Part 2 of the Randomized, Open-Label, Phase III COLUMBUS Trial.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023 Oct 10
PubMed 37506329 (opens in a new tab)DOI 10.1200/JCO.22.02322 (opens in a new tab)
Treatment experience with encorafenib plus binimetinib for BRAF V600-mutant metastatic melanoma: management insights for clinical practice.
Melanoma research · 2023 Oct 1
PubMed 37534686 (opens in a new tab)DOI 10.1097/CMR.0000000000000891 (opens in a new tab)
COLUMBUS 5-year update: a randomized, open-label, phase III trial of encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF.
Future oncology (London, England) · 2023 May
PubMed 37309702 (opens in a new tab)DOI 10.2217/fon-2022-1258 (opens in a new tab)
Cost-effectiveness of immune checkpoint inhibition and targeted treatment in combination as adjuvant treatment of patient with BRAF-mutant advanced melanoma.
BMC health services research · 2023 Jan 18
PubMed 36653848 (opens in a new tab)DOI 10.1186/s12913-023-09058-7 (opens in a new tab)
COLUMBUS 5-Year Update: A Randomized, Open-Label, Phase III Trial of Encorafenib Plus Binimetinib Versus Vemurafenib or Encorafenib in Patients With BRAF V600-Mutant Melanoma.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022 Dec 20
PubMed 35862871 (opens in a new tab)DOI 10.1200/JCO.21.02659 (opens in a new tab)
Quality of life in patients with BRAF-mutant melanoma receiving the combination encorafenib plus binimetinib: Results from a multicentre, open-label, randomised, phase III study (COLUMBUS).
European journal of cancer (Oxford, England : 1990) · 2021 Jul
PubMed 34091420 (opens in a new tab)DOI 10.1016/j.ejca.2021.04.028 (opens in a new tab)
Adverse events associated with encorafenib plus binimetinib in the COLUMBUS study: incidence, course and management.
European journal of cancer (Oxford, England : 1990) · 2019 Sep
PubMed 31437754 (opens in a new tab)DOI 10.1016/j.ejca.2019.07.016 (opens in a new tab)
Overall survival in patients with BRAF-mutant melanoma receiving encorafenib plus binimetinib versus vemurafenib or encorafenib (COLUMBUS): a multicentre, open-label, randomised, phase 3 trial.
The Lancet. Oncology · 2018 Oct
PubMed 30219628 (opens in a new tab)DOI 10.1016/S1470-2045(18)30497-2 (opens in a new tab)
Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial.
The Lancet. Oncology · 2018 May
PubMed 29573941 (opens in a new tab)DOI 10.1016/S1470-2045(18)30142-6 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT01909453 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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