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NCT01621490 · ClinicalTrials.gov registry record · Phase 1
PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 170
- Enrollment target
NCT01621490: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT01621490 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 170 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (183% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01621490, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 170 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate pharmacodynamic changes of Nivolumab and Nivolumab in combination with Ipilimumab treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with advanced melanoma (unresectable or advanced)
Primary Outcome
Baseline and post-treatment modulation of serum levels of chemokines, cytokines and other immune mediators were assessed by techniques that included ELISA or other multiplex-based assay methods. Primary analysis included IFN-gamma and IFN-gamma inducible factors, including chemokine \[C-X-C motif\] ligand 9 (CXCL9) and CXCL10
Interventions
- DRUG Ipilimumab
- BIOLOGICAL Nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2012-09-27 |
| Est. Completion | 2018-10-25 |
| Phase | Phase 1 |
What the finished NCT01621490 record still lists
NCT01621490 is an interventional study that assigns participants to a tested intervention. The registered 170 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 (183% higher).
The record links to 0 conditions, and to 2 interventions - of which Ipilimumab is the first listed.
NCT01621490 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01621490 about?
NCT01621490 is a clinical study titled "PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma". The purpose of this study is to evaluate pharmacodynamic changes of Nivolumab and Nivolumab in combination with Ipilimumab treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with advanced melanoma (unresectable or advanced)
What is the current status of trial NCT01621490?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 170 participants. The study started on 2012-09-27. Estimated completion is 2018-10-25.
What interventions are being tested in trial NCT01621490?
The interventions under investigation include: Ipilimumab (DRUG), Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01621490?
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 NCT01621490's enrollment target sits among peer trials
170 325th of 2000 higher than 1,675 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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