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NCT01673854 · ClinicalTrials.gov registry record · Phase 2
Phase II Safety Study of Vemurafenib Followed by Ipilimumab in Subjects With V600 BRAF Mutated Advanced Melanoma
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
NCT01673854: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT01673854 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 70 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01673854, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety profile of vemurafenib, 960 mg, administered for 6 weeks, followed by ipilimumab monotherapy in patients with BRAF V600 mutated advanced/metastatic melanoma.
Primary Outcome
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Drug-related=having certain, probable, possible, or unknown relationship to study drug. Grading criteria for AEs: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.
Interventions
- DRUG Ipilimumab
- BIOLOGICAL Vemurafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2012-09-13 |
| Est. Completion | 2015-05-12 |
| Phase | Phase 2 |
What the finished NCT01673854 record still lists
NCT01673854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Ipilimumab is the first listed.
NCT01673854 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01673854 about?
NCT01673854 is a clinical study titled "Phase II Safety Study of Vemurafenib Followed by Ipilimumab in Subjects With V600 BRAF Mutated Advanced Melanoma". The purpose of this study is to assess the safety profile of vemurafenib, 960 mg, administered for 6 weeks, followed by ipilimumab monotherapy in patients with BRAF V600 mutated advanced/metastatic melanoma.
What is the current status of trial NCT01673854?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2012-09-13. Estimated completion is 2015-05-12.
What interventions are being tested in trial NCT01673854?
The interventions under investigation include: Ipilimumab (DRUG), Vemurafenib (BIOLOGICAL).
Who is sponsoring clinical trial NCT01673854?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01673854's enrollment target sits among peer trials
70 937th of 2000 higher than 1,036 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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