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NCT03425461 · ClinicalTrials.gov registry record · Phase 1
Anti-SEMA4D Monoclonal Antibody VX15/2503 With Nivolumab or Ipilimumab in Treating Patients With Stage III or IV Melanoma
A Phase 1 study, sponsored by Jonsson Comprehensive Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT03425461: Clinical Trial Phase 1 study, sponsored by Jonsson Comprehensive Cancer Center.
NCT03425461 is a Phase 1 study that was terminated before completion, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03425461, a Phase 1 study, was terminated before completion, sponsored by Jonsson Comprehensive Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This randomized pilot phase I trial studies the side effects and best dose of anti-SEMA4D monoclonal antibody VX15/2503 when given together with nivolumab or ipilimumab in treating patients with stage III or IV melanoma. Monoclonal antibodies, such as anti-SEMA4D monoclonal antibody VX15/2503, nivolumab, and ipilimumab, may interfere with the ability of tumor cells to grow and spread.
Primary Outcome
Simple descriptive statistics will be used to summarize toxicities observed at each monitoring visit through the treatment and follow up period such as absolute neutrophil count), severity (by Toxicity Table) and nadir or maximum values for the laboratory measures, time of onset (i.e. course number), duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and by course. Baseline information (e.g. the extent of prior therapy) and demog
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
- OTHER Pharmacological Study
- BIOLOGICAL Anti-SEMA4D Monoclonal Antibody VX15/2503
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-06-14 |
| Est. Completion | 2021-03-04 |
| Phase | Phase 1 |
Why NCT03425461 stopped before completion
NCT03425461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03425461 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03425461 about?
NCT03425461 is a clinical study titled "Anti-SEMA4D Monoclonal Antibody VX15/2503 With Nivolumab or Ipilimumab in Treating Patients With Stage III or IV Melanoma". This randomized pilot phase I trial studies the side effects and best dose of anti-SEMA4D monoclonal antibody VX15/2503 when given together with nivolumab or ipilimumab in treating patients with stage III or IV melanoma. Monoclonal antibodies, such as anti-SEMA4D monoclonal antibody VX15/2503, nivol...
What is the current status of trial NCT03425461?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2018-06-14. Estimated completion is 2021-03-04.
What interventions are being tested in trial NCT03425461?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL), Pharmacological Study (OTHER), Anti-SEMA4D Monoclonal Antibody VX15/2503 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03425461?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03425461's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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