Clinical trial
Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818…
NCT01909453 · Pfizer, Industry · Completed
Key facts
| NCT number | NCT01909453 |
|---|---|
| Title | Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma |
| Official title | A 2-part Phase III Randomized, Open Label, Multicenter Study of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma |
| Acronym | COLUMBUS |
| Lead sponsor | Pfizer, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Melanoma |
| Intervention type | Drug |
| Interventions | LGX818, MEK162, vemurafenib |
| Enrollment | 921 |
| Start date | Sep 12, 2013 |
| Primary completion | Nov 9, 2016 |
| Completion | Sep 3, 2024 |
| First posted | Jul 26, 2013 |
| Last update posted | May 29, 2025 |
| Countries | Argentina, Australia, Brazil, Canada, Colombia, Czechia, France, Germany, Greece, Hungary, Israel, Italy and 17 more |
At a glance
- 100–999 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: