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NCT02247349 · ClinicalTrials.gov registry record · Phase 1
BMS-986012 in Relapsed/Refractory SCLC
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 106
- Enrollment target
NCT02247349: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT02247349 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 106 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02247349, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 106 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of BMS-986012 alone and in combination with nivolumab in patients with relapsed/refractory SCLC.
Primary Outcome
Number of participants with any grade adverse events (AEs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Interventions
- BIOLOGICAL Nivolumab
- BIOLOGICAL BMS-986012 (anti-fucosyl-GM1)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2014-11-14 |
| Est. Completion | 2022-12-22 |
| Phase | Phase 1 |
What the finished NCT02247349 record still lists
NCT02247349 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% higher).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT02247349 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02247349 about?
NCT02247349 is a clinical study titled "BMS-986012 in Relapsed/Refractory SCLC". The purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of BMS-986012 alone and in combination with nivolumab in patients with relapsed/refractory SCLC.
What is the current status of trial NCT02247349?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2014-11-14. Estimated completion is 2022-12-22.
What interventions are being tested in trial NCT02247349?
The interventions under investigation include: Nivolumab (BIOLOGICAL), BMS-986012 (anti-fucosyl-GM1) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02247349?
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 NCT02247349's enrollment target sits among peer trials
106 531st of 2000 higher than 1,468 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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