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NCT03138499 · ClinicalTrials.gov registry record · Phase 3
A Study of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Patients With Advanced Stage Classical Hodgkin Lymphoma, Who Are Relapsed/ Refractory or Who Are Not Eligible for Autologous Stem Cell Transplant,
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Terminated
- Registry status
- Phase 3
- Development phase
- 23
- Enrollment target
NCT03138499: Clinical Trial Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT03138499 is a Phase 3 study that was terminated before completion, run by Bristol-Myers Squibb. The registered enrollment target is 23 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03138499, a Phase 3 study, was terminated before completion, sponsored by Bristol-Myers Squibb.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 23 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether an investigational immuno-therapy combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The participants of this trial will comprise of patients who have relapsed or did not respond to treatment and are not eligible for stem cell transplant
Primary Outcome
Progression Free Survival (PFS) is defined as time from date of randomization to death, or disease progression per investigator assessment estimated using the Kaplan-Meier (KM) product-limit method.
Interventions
- BIOLOGICAL Nivolumab
- BIOLOGICAL Brentuximab vedotin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2017-06-26 |
| Est. Completion | 2021-02-22 |
| Phase | Phase 3 |
Why NCT03138499 stopped before completion
NCT03138499 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT03138499 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03138499 about?
NCT03138499 is a clinical study titled "A Study of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Patients With Advanced Stage Classical Hodgkin Lymphoma, Who Are Relapsed/ Refractory or Who Are Not Eligible for Autologous Stem Cell Transplant,". The purpose of this study is to determine whether an investigational immuno-therapy combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The participants of this trial will ...
What is the current status of trial NCT03138499?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 23 participants. The study started on 2017-06-26. Estimated completion is 2021-02-22.
What interventions are being tested in trial NCT03138499?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Brentuximab vedotin (BIOLOGICAL).
Who is sponsoring clinical trial NCT03138499?
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 NCT03138499's enrollment target sits among peer trials
23 1952nd of 2000 higher than 48 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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