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NCT04410445 · ClinicalTrials.gov registry record · Phase 3
Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence
A Phase 3 study, sponsored by Nektar Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 765
- Enrollment target
NCT04410445: Clinical Trial Phase 3 study, sponsored by Nektar Therapeutics.
NCT04410445 is a Phase 3 study that was terminated before completion, run by Nektar Therapeutics. The registered enrollment target is 765 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04410445, a Phase 3 study, was terminated before completion, sponsored by Nektar Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 765 participants
- Enrollment target
Study Summary
The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous melanoma who are at high risk for recurrence.
Primary Outcome
Recurrence-free Survival (RFS) of bempegaldesleukin plus nivolumab versus nivolumab alone is determined based on the disease recurrence date provided by Blinded Independent Central Review (BICR) and is defined as the time between date of randomization and date of first recurrence (local, regional, or distant metastasis by BICR), new primary melanoma (by BICR), or all-cause death, whichever occurs first.
Interventions
- BIOLOGICAL Nivolumab
- BIOLOGICAL Bempegaldesleukin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 765 participants |
| Start Date | 2020-07-27 |
| Est. Completion | 2022-09-22 |
| Phase | Phase 3 |
Why NCT04410445 stopped before completion
NCT04410445 is an interventional study that assigns participants to a tested intervention. The registered 765 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT04410445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04410445 about?
NCT04410445 is a clinical study titled "Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence". The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous melanoma who are at high risk for recurrence.
What is the current status of trial NCT04410445?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 765 participants. The study started on 2020-07-27. Estimated completion is 2022-09-22.
What interventions are being tested in trial NCT04410445?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Bempegaldesleukin (BIOLOGICAL).
Who is sponsoring clinical trial NCT04410445?
This trial is sponsored by Nektar Therapeutics, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04410445's enrollment target sits among peer trials
765 446th of 2000 higher than 1,552 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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