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NCT02581631 · ClinicalTrials.gov registry record · Phase 1
An Investigational Immuno-therapy Safety and Effectiveness Study of Nivolumab in Combination With Brentuximab Vedotin to Treat Non-Hodgkin Lymphomas
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 145
- Enrollment target
NCT02581631: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT02581631 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 145 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (142% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02581631, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 145 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether Nivolumab, in combination with brentuximab vedotin, is safe and effective in patients with certain subtypes of non-Hodgkin's lymphomas with CD30 expression that have not responded to treatment or have come back. The subtypes we are studying are Diffuse Large B-Cell Lymphoma (DLBCL), Peripheral T-Cell Lymphoma (PTCL), Cutaneous T-Cell Lymphoma (CTCL), Primary Mediastinal Large B-Cell Lymphoma (PMBL) and Mediastinal Gray Zone Lymphoma (MGZL).
Primary Outcome
DLTs are defined as any study drug-related toxicity (brentuximab vedotin or nivolumab) that requires either a dose reduction or delay of more than 7 days of either study drug in Cycle 2 or delays the Cycle 3 Day 1 administration of combined treatment by more than 7 days.
Interventions
- BIOLOGICAL Nivolumab
- DRUG Brentuximab Vedotin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2016-02-11 |
| Est. Completion | 2022-02-07 |
| Phase | Phase 1 |
What the finished NCT02581631 record still lists
NCT02581631 is an interventional study that assigns participants to a tested intervention. The registered 145 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 (142% higher).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT02581631 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02581631 about?
NCT02581631 is a clinical study titled "An Investigational Immuno-therapy Safety and Effectiveness Study of Nivolumab in Combination With Brentuximab Vedotin to Treat Non-Hodgkin Lymphomas". The purpose of this study is to determine whether Nivolumab, in combination with brentuximab vedotin, is safe and effective in patients with certain subtypes of non-Hodgkin's lymphomas with CD30 expression that have not responded to treatment or have come back. The subtypes we are studying are Diffu...
What is the current status of trial NCT02581631?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 145 participants. The study started on 2016-02-11. Estimated completion is 2022-02-07.
What interventions are being tested in trial NCT02581631?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Brentuximab Vedotin (DRUG).
Who is sponsoring clinical trial NCT02581631?
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 NCT02581631's enrollment target sits among peer trials
145 391st of 2000 higher than 1,607 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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