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NCT04815720 · ClinicalTrials.gov registry record · Phase 1
Pepinemab in Combination With Pembrolizumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
A Phase 1 study of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC), sponsored by Vaccinex.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
- 15
- Study locations
NCT04815720: Completed Phase 1 study of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC), sponsored by Vaccinex.
NCT04815720 is a Phase 1 study of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC) that has completed, run by Vaccinex. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). The trial reports 15 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04815720, a Phase 1 study of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC), has completed, sponsored by Vaccinex.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
- 15
- Study locations
Study Summary
The purpose of the study is to evaluate the safety and tolerability of pepinemab in combination with pembrolizumab as first-line treatment and determine a recommended Phase 2 dose (RP2D) in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).
Primary Outcome
TEAE's are defined as Adverse Events (AEs) with onset after date-time of first dose, or medical conditions present prior to the start of IMP but increased in severity or relationship after date-time of first dose of IMP.
Conditions Studied
Interventions
- DRUG pepinemab + pembrolizumab
Study Locations (15)
California
- California Cancer Associates for Research and Excellence (CCARE)-Fresno - Fresno
- UCSF Medical Center at Mission Bay - San Francisco
Florida
- AdventHealth Celebration - Celebration
- AdventHealth Orlando - Orlando
New York
- Northwell Health - Centers for Advanced Medicine - Lake Success
- University of Rochester - Rochester
Arkansas
- Highlands Oncology Group, PA - North Hills - Springdale
Connecticut
- Yale Cancer Center - New Haven
Georgia
- Emory Saint Joseph's Hospital - Atlanta
Maryland
- American Oncology Partners of Maryland, PA - Bethesda
Missouri
- Siteman Cancer Center - Washington University Medical Campus - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2021-08-09 |
| Est. Completion | 2024-07-24 |
| Phase | Phase 1 |
What the finished NCT04815720 record still lists
NCT04815720 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).
The record links to 1 condition, with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC) appearing as the primary indexed condition, and to 1 intervention - of which pepinemab + pembrolizumab is the first listed.
NCT04815720 lists 15 locations in 12 states (California, Florida, New York).
Frequently Asked Questions
What is clinical trial NCT04815720 about?
NCT04815720 is a clinical study titled "Pepinemab in Combination With Pembrolizumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck". The purpose of the study is to evaluate the safety and tolerability of pepinemab in combination with pembrolizumab as first-line treatment and determine a recommended Phase 2 dose (RP2D) in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).
What is the current status of trial NCT04815720?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2021-08-09. Estimated completion is 2024-07-24.
What conditions does trial NCT04815720 study?
This clinical trial studies the following conditions: Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC).
What interventions are being tested in trial NCT04815720?
The interventions under investigation include: pepinemab + pembrolizumab (DRUG).
Who is sponsoring clinical trial NCT04815720?
This trial is sponsored by Vaccinex, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04815720 being conducted?
This trial has 15 study locations across Arkansas, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04815720's enrollment target sits among peer trials
49 1017th of 2000 higher than 976 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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