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NCT01400451 · ClinicalTrials.gov registry record · Phase 1
Ph I Ipilimumab Vemurafenib Combo in Patients With v-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF)
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Terminated
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01400451: Clinical Trial Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT01400451 is a Phase 1 study that was terminated before completion, run by Bristol-Myers Squibb. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01400451, a Phase 1 study, was terminated before completion, sponsored by Bristol-Myers Squibb.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
Treatment of subjects who have metastatic melanoma that expresses an activated mutant form of the BRAF oncogene (V600E) with a combination of the specific BRAF inhibitor, Vemurafenib, and the Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) inhibitor mAb Ipilimumab will be safe and feasible and will show preliminary evidence of anti-tumor efficacy and survival in comparison to historical results following treatment with either agent alone.
Primary Outcome
AEs graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hos
Interventions
- DRUG Vemurafenib
- DRUG Ipilimumab (BMS-734016)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-11 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
Why NCT01400451 stopped before completion
NCT01400451 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Vemurafenib is the first listed.
NCT01400451 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01400451 about?
NCT01400451 is a clinical study titled "Ph I Ipilimumab Vemurafenib Combo in Patients With v-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF)". Treatment of subjects who have metastatic melanoma that expresses an activated mutant form of the BRAF oncogene (V600E) with a combination of the specific BRAF inhibitor, Vemurafenib, and the Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) inhibitor mAb Ipilimumab will be safe and feasible and will show p...
What is the current status of trial NCT01400451?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-11. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01400451?
The interventions under investigation include: Vemurafenib (DRUG), Ipilimumab (BMS-734016) (DRUG).
Who is sponsoring clinical trial NCT01400451?
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 NCT01400451's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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