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NCT03620019 · ClinicalTrials.gov registry record · Phase 2
Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma
A Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT03620019: Completed Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT03620019 is a Phase 2 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03620019, a Phase 2 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
This is a multicenter open-label, single-arm, phase II study designed to investigate the pharmacodynamic and antitumor effects of denosumab alone and in combination with an anti-Programmed death-1 or Programmed death ligand 1 (PD1) agent (pembrolizumab or nivolumab) in patients with unresectable Programmed death-1 or Programmed death ligand 1 (PD-1/PD-L1) inhibitor-naïve regional and distant metastatic melanoma (The American Joint Committee on Cancer (AJCC) stage III/IV). The pharmacodynamic and antitumor effects will be investigated by performing translational research on peripheral blood and tumor tissue collected before and during denosumab alone and in combination with anti-PD-1 treatment.
Primary Outcome
The antitumor effect of denosumab alone (i.e., after two loading doses of denosumab are given on day 1 and day 8) in patients with unresectable stage III or distant metastatic Programmed death-1 or Programmed death ligand 1 (PD-1/PD-L1) inhibitor-naïve cutaneous melanoma (stage III/IV) will be assessed by performing translational research on peripheral blood samples collected at baseline and on day 21 of the study. The hypothesis is that denosumab treatment will prevent the destruction of autore
Interventions
- DRUG Pembrolizumab
- DRUG Nivolumab
- DRUG Denosumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2018-09-10 |
| Est. Completion | 2023-08-15 |
| Phase | Phase 2 |
What the finished NCT03620019 record still lists
NCT03620019 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03620019 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03620019 about?
NCT03620019 is a clinical study titled "Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma". This is a multicenter open-label, single-arm, phase II study designed to investigate the pharmacodynamic and antitumor effects of denosumab alone and in combination with an anti-Programmed death-1 or Programmed death ligand 1 (PD1) agent (pembrolizumab or nivolumab) in patients with unresectable Pro...
What is the current status of trial NCT03620019?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2018-09-10. Estimated completion is 2023-08-15.
What interventions are being tested in trial NCT03620019?
The interventions under investigation include: Pembrolizumab (DRUG), Nivolumab (DRUG), Denosumab (DRUG).
Who is sponsoring clinical trial NCT03620019?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03620019's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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