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ACTIVE NOT RECRUITING Phase 3

Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

NCT06790966 · View on ClinicalTrials.gov ↗

Study Summary

This is a global, multi-center, Phase 3 study that is randomized 2:1, controlled, and open label to evaluate PDS0101 (Versamune + HPVMix) in combination with pembrolizumab vs. pembrolizumab monotherapy as first-line treatment in patients with unresectable recurrent or metastatic HPV16-positive HNSCC expressing programmed cell death ligand-1 (PD-L1) with combined positive score (CPS) ≥1.

Interventions

  • DRUG Pembrolizumab Monotherapy
  • COMBINATION_PRODUCT Combination Treatment of PDS0101 and Pembrolizumab

Study Locations (20)

Florida

  • Mayo Clinic Florida — Jacksonville
  • Florida Cancer Affiliates - Ocala Oncology — Ocala
  • SCRI - Florida Cancer Specialists — Orlando

Kentucky

  • University of Kentucky — Lexington
  • Norton Cancer Institute — Louisville
  • University of Louisville — Louisville

California

  • Marin Cancer Care — Greenbrae
  • University of California, Orange — Orange

Michigan

  • University of Michigan — Ann Arbor
  • Karmanos Cancer Institute — Detroit

Pennsylvania

  • Penn State Health — Hershey
  • Fox Chase Cancer Center — Philadelphia

Arizona

  • Mayo Clinic Arizona — Phoenix

Connecticut

  • Yale University — New Haven

Georgia

  • Emory University - Winship Cancer Institute (WCI) — Atlanta

Trial Details

FieldValue
Enrollment Target 351 participants
Start Date 2025-05-30
Est. Completion 2029-02
Phase Phase 3

Sponsor

PDS Biotechnology

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06790966

The ClinicalTrials.gov registry entry for NCT06790966 describes a study currently listed as active not recruiting. It is categorized as Phase 3, 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 351 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PDS Biotechnology, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with HPV Positive Oropharyngeal Squamous Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions — of which Pembrolizumab Monotherapy 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: NCT06790966 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, Kentucky, California. 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 NCT06790966 about?

NCT06790966 is a clinical study titled "Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma". This is a global, multi-center, Phase 3 study that is randomized 2:1, controlled, and open label to evaluate PDS0101 (Versamune + HPVMix) in combination with pembrolizumab vs. pembrolizumab monotherapy as first-line treatment in patients with unresectable recurrent or metastatic HPV16-positive HNSCC...

What is the current status of trial NCT06790966?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 351 participants. The study started on 2025-05-30. Estimated completion is 2029-02.

What conditions does trial NCT06790966 study?

This clinical trial studies the following conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma, Metastatic Head and Neck Cancer, Neoplasms, Head and Neck, Recurrent Head and Neck Cancer, Unresectable Head and Neck Squamous Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06790966?

The interventions under investigation include: Pembrolizumab Monotherapy (DRUG), Combination Treatment of PDS0101 and Pembrolizumab (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06790966?

This trial is sponsored by PDS Biotechnology, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06790966 being conducted?

This trial has 20 study locations across Arizona, 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