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NCT03690986 · ClinicalTrials.gov registry record · Phase 1
VX15/2503 in Combination With Ipilimumab or Nivolumab in Patients With Head and Neck Cancer
A Phase 1 study of Squamous Cell Carcinoma of the Head and Neck, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT03690986: Recruiting Phase 1 study of Squamous Cell Carcinoma of the Head and Neck, sponsored by Emory University.
NCT03690986 is a Phase 1 study of Squamous Cell Carcinoma of the Head and Neck that is actively recruiting participants, run by Emory University. The registered enrollment target is 50 participants, below the 144-participant average among 29 other Squamous Cell Carcinoma of the Head and Neck trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03690986, a Phase 1 study of Squamous Cell Carcinoma of the Head and Neck, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies how well anti-semaphorin 4D (SEMA4D) monoclonal antibody VX15/2503 (VX15/2503) with or without ipilimumab and/or nivolumab work in treating patients with stage I-IVA head and neck squamous cell cancer. Monoclonal antibodies, such as VX15/2503, ipilimumab, and nivolumab, may interfere with the ability of tumor cells to grow and spread.
Primary Outcome
Specimens from surgical resection will be collected under the guidance of the collaborating pathologist and tissue procurement staff at the time of surgery to capture tissue in excess of that needed for clinical staging and diagnostic purposes. Tumor specimens will be fixed in 10% formalin, embedded in paraffin and biomarkers related to activated HNSCC stroma will be assessed via immunohistochemical analysis.
Conditions Studied
Interventions
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
- BIOLOGICAL VX15/2503
Study Locations (1)
Georgia
- Emory University Hospital Midtown - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-11-01 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 1 |
What NCT03690986 shows while recruiting
NCT03690986 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 144-participant average among 29 other Squamous Cell Carcinoma of the Head and Neck trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Squamous Cell Carcinoma of the Head and Neck appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT03690986 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT03690986 about?
NCT03690986 is a clinical study titled "VX15/2503 in Combination With Ipilimumab or Nivolumab in Patients With Head and Neck Cancer". This phase I trial studies how well anti-semaphorin 4D (SEMA4D) monoclonal antibody VX15/2503 (VX15/2503) with or without ipilimumab and/or nivolumab work in treating patients with stage I-IVA head and neck squamous cell cancer. Monoclonal antibodies, such as VX15/2503, ipilimumab, and nivolumab, ma...
What is the current status of trial NCT03690986?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2018-11-01. Estimated completion is 2027-11-30.
What conditions does trial NCT03690986 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma of the Head and Neck.
What interventions are being tested in trial NCT03690986?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL), VX15/2503 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03690986?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03690986 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03690986's enrollment target sits among peer trials
50 16th of 29 higher than 14 of 29 other Squamous Cell Carcinoma of the Head and Neck trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Squamous Cell Carcinoma of the Head and Neck 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.
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