Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC

ClinicalTrials.gov ID: NCT04260126

Public ClinicalTrials.gov record NCT04260126. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 20, 2026, 7:17 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase II, Open-Label, Multi-Center Study of PDS0101 and Pembrolizumab (KEYTRUDA®) Combination Immunotherapy in Subjects With Recurrent and/or Metastatic HNSCC and High-Risk HPV16 Infection

Study identification

NCT ID: NCT04260126
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: PDS Biotechnology Corp.; Industry
Enrollment: 95 participants

Conditions and interventions

Conditions

Interventions

Pembrolizumab (KEYTRUDA®) and PDS0101 Combination Product

Combination Product

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 28, 2021
Primary completion: May 13, 2025
Completion: May 13, 2025
Last update posted: Sep 30, 2025

2021 – 2025

United States locations

U.S. sites: 18
U.S. states: 15
U.S. cities: 18

Facility	City	State	ZIP	Site status
Marin Cancer Center	Greenbrae	California	94904	—
University of California San Francisco	San Francisco	California	94158	—
Mayo Clinic	Jacksonville	Florida	32224	—
Cleveland Clinic Florida	Weston	Florida	33331	—
University of Kentucky Chandler Medical Center - Markey Cancer Center	Lexington	Kentucky	40536	—
University of Maryland Greenebaum Comprehensive Cancer Center	Baltimore	Maryland	21201	—
University of Michigan	Ann Arbor	Michigan	48109	—
Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	48201	—
Mayo Clinic	Rochester	Minnesota	55902	—
Atlantic Health	Morristown	New Jersey	07962	—
University of North Carolina	Chapel Hill	North Carolina	27599	—
Ohio State University	Columbus	Ohio	43210	—
Fox Chase Cancer Center	Philadelphia	Pennsylvania	19111	—
Medical University of South Carolina Hollings Cancer Center	Charleston	South Carolina	29425	—
University of Tennessee	Knoxville	Tennessee	37920	—
Texas Oncology - Sammons Cancer Center	Dallas	Texas	75246	—
The University of Virginia	Charlottesville	Virginia	22908	—
West Virginia University	Morgantown	West Virginia	26506	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04260126, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 30, 2025 · Synced May 20, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04260126 live on ClinicalTrials.gov.

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