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COMPLETED Phase 1

Pepinemab in Combination With Pembrolizumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

NCT04815720 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 49 participants
Start Date 2021-08-09
Est. Completion 2024-07-24
Phase Phase 1

Sponsor

Vaccinex

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04815720

The ClinicalTrials.gov registry entry for NCT04815720 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vaccinex, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04815720 reports 15 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04815720?

The interventions under investigation include: pepinemab + pembrolizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04815720?

This trial is sponsored by Vaccinex, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial