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NCT01721759 · ClinicalTrials.gov registry record · Phase 2
Study of Nivolumab (BMS-936558) in Patients With Advanced or Metastatic Squamous Cell Nonsmall-cell Lung Cancer Who Have Received At Least 2 Prior Systemic Regimens
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 117
- Enrollment target
NCT01721759: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT01721759 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 117 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01721759, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 117 participants
- Enrollment target
Study Summary
The purpose of the study is to assess the objective response rate (change in tumor size from baseline) in patients with advanced or metastatic squamous cell nonsmall-cell lung cancer treated with Nivolumab (BMS-936558) after failure of 2 prior systemic regimens
Primary Outcome
ORR is defined as the percentage of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment. The IRC-assessed ORR (using RECIST v1.1, to confirm response and based on the IRC global radiology review after incorporation of on-study clinical data) was estimated using a binomial response rate and its corresponding 2-sided 95% exact confidence intervals using the Clopper-Pearson method.
Interventions
- DRUG Nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2012-11-16 |
| Est. Completion | 2021-04-22 |
| Phase | Phase 2 |
What the finished NCT01721759 record still lists
NCT01721759 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% lower).
The record links to 0 conditions, and to 1 intervention - of which Nivolumab is the first listed.
NCT01721759 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01721759 about?
NCT01721759 is a clinical study titled "Study of Nivolumab (BMS-936558) in Patients With Advanced or Metastatic Squamous Cell Nonsmall-cell Lung Cancer Who Have Received At Least 2 Prior Systemic Regimens". The purpose of the study is to assess the objective response rate (change in tumor size from baseline) in patients with advanced or metastatic squamous cell nonsmall-cell lung cancer treated with Nivolumab (BMS-936558) after failure of 2 prior systemic regimens
What is the current status of trial NCT01721759?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 117 participants. The study started on 2012-11-16. Estimated completion is 2021-04-22.
What interventions are being tested in trial NCT01721759?
The interventions under investigation include: Nivolumab (DRUG).
Who is sponsoring clinical trial NCT01721759?
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 NCT01721759's enrollment target sits among peer trials
117 623rd of 2000 higher than 1,378 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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