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NCT01844505 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 945
- Enrollment target
NCT01844505: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT01844505 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 945 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01844505, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 945 participants
- Enrollment target
Study Summary
The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.
Primary Outcome
PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die we
Interventions
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
- BIOLOGICAL Placebo for Nivolumab
- BIOLOGICAL Placebo for Ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 945 participants |
| Start Date | 2013-06-11 |
| Est. Completion | 2024-04-19 |
| Phase | Phase 3 |
What the finished NCT01844505 record still lists
NCT01844505 is an interventional study that assigns participants to a tested intervention. The registered 945 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 (22% higher).
The record links to 0 conditions, and to 4 interventions - of which Nivolumab is the first listed.
NCT01844505 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01844505 about?
NCT01844505 is a clinical study titled "Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)". The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.
What is the current status of trial NCT01844505?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 945 participants. The study started on 2013-06-11. Estimated completion is 2024-04-19.
What interventions are being tested in trial NCT01844505?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL), Placebo for Nivolumab (BIOLOGICAL), Placebo for Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01844505?
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 NCT01844505's enrollment target sits among peer trials
945 334th of 2000 higher than 1,667 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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