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NCT01909453 · ClinicalTrials.gov registry record · Phase 3
Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 921
- Enrollment target
NCT01909453: Completed Phase 3 study, sponsored by Pfizer.
NCT01909453 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 921 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01909453, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 921 participants
- Enrollment target
Study Summary
This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized. Part 1: Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms: 1. LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm) 2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or 3. vemurafenib 960 mg BID (denoted as vemurafenib arm) Part 2: Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms: 1. LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or 2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm)
Primary Outcome
PFS was defined as the time from the date of randomization to the date of the first documented disease progression (PD) or death due to any cause, whichever occurs first. PFS was determined based on tumor assessment (RECIST version 1.1 criteria) as per BIRC/central review and survival information. If a participant did not had an event at the time of the analysis cut-off or at the start of any new anti-cancer therapy, data was censored at the date of last adequate tumor assessment. PD was defined
Interventions
- DRUG MEK162
- DRUG LGX818
- DRUG vemurafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 921 participants |
| Start Date | 2013-09-12 |
| Est. Completion | 2024-09-03 |
| Phase | Phase 3 |
What the finished NCT01909453 record still lists
NCT01909453 is an interventional study that assigns participants to a tested intervention. The registered 921 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% higher).
The record links to 0 conditions, and to 3 interventions - of which MEK162 is the first listed.
NCT01909453 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01909453 about?
NCT01909453 is a clinical study titled "Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma". This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately ...
What is the current status of trial NCT01909453?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 921 participants. The study started on 2013-09-12. Estimated completion is 2024-09-03.
What interventions are being tested in trial NCT01909453?
The interventions under investigation include: MEK162 (DRUG), LGX818 (DRUG), vemurafenib (DRUG).
Who is sponsoring clinical trial NCT01909453?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01909453's enrollment target sits among peer trials
921 345th of 2000 higher than 1,656 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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