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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 is a Phase 2 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 25 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03620019
The ClinicalTrials.gov registry entry for NCT03620019 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03620019 reports 0 study locations.
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.
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