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NCT05297565 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 14
- Enrollment target
NCT05297565: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT05297565 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 14 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05297565, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma.
Primary Outcome
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 treatment that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Interventions
- BIOLOGICAL Nivolumab
- BIOLOGICAL Nivolumab/rHuPH20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2022-08-02 |
| Est. Completion | 2024-02-08 |
| Phase | Phase 3 |
What the finished NCT05297565 record still lists
NCT05297565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT05297565 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05297565 about?
NCT05297565 is a clinical study titled "A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection". The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma.
What is the current status of trial NCT05297565?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 14 participants. The study started on 2022-08-02. Estimated completion is 2024-02-08.
What interventions are being tested in trial NCT05297565?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Nivolumab/rHuPH20 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05297565?
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 NCT05297565's enrollment target sits among peer trials
14 1983rd of 2000 higher than 17 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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