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NCT03580382 · ClinicalTrials.gov registry record · Phase 1
Study of CDX-3379, a Human Monoclonal Antibody Targeting ERBB3, in Combination With the MEK Inhibitor, Trametinib, in Patients With Advanced Stage NRAS Mutant and BRAF/NRAS Wildtype (WT) Melanoma
A Phase 1 study, sponsored by NYU Langone Health.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT03580382: Clinical Trial Phase 1 study, sponsored by NYU Langone Health.
NCT03580382 is a Phase 1 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03580382, a Phase 1 study, was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
The main goal of this study is to test if it is safe and effective to give CDX-3379 together to treat advanced melanoma in patients with the NRAS mutation and BRAF/NRAS wildtype.
Primary Outcome
response rate, will be compared with the historically reported response rate for the single agent trametinib in NRAS and BRAF/NRAS WT melenoma
Interventions
- DRUG Trametinib daily Until PD
- DRUG CDX-3379 (ERBB3 antibody)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2018-07-06 |
| Est. Completion | 2018-09-26 |
| Phase | Phase 1 |
Why NCT03580382 stopped before completion
NCT03580382 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Trametinib daily Until PD is the first listed.
NCT03580382 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03580382 about?
NCT03580382 is a clinical study titled "Study of CDX-3379, a Human Monoclonal Antibody Targeting ERBB3, in Combination With the MEK Inhibitor, Trametinib, in Patients With Advanced Stage NRAS Mutant and BRAF/NRAS Wildtype (WT) Melanoma". The main goal of this study is to test if it is safe and effective to give CDX-3379 together to treat advanced melanoma in patients with the NRAS mutation and BRAF/NRAS wildtype.
What is the current status of trial NCT03580382?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2018-07-06. Estimated completion is 2018-09-26.
What interventions are being tested in trial NCT03580382?
The interventions under investigation include: Trametinib daily Until PD (DRUG), CDX-3379 (ERBB3 antibody) (DRUG).
Who is sponsoring clinical trial NCT03580382?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03580382's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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