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NCT06790966 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Metastatic Head and Neck Cancer, sponsored by PDS Biotechnology.

Active
Registry status
Phase 3
Development phase
351
Enrollment target
20
Study locations

NCT06790966 is a Phase 3 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Metastatic Head and Neck Cancer that is active but no longer recruiting, run by PDS Biotechnology. The registered enrollment target is 351 participants, above the 70-participant average among 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target (401% higher). The trial reports 20 study locations across 13 states.

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The verdict

NCT06790966, a Phase 3 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Metastatic Head and Neck Cancer, is active but no longer recruiting, sponsored by PDS Biotechnology.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
351 participants
Enrollment target
20
Study locations

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.

Conditions Studied

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

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

3 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, categorized as Phase 3. The registered enrollment target is 351 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 70-participant average among 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target (401% higher). The listed sponsor is PDS Biotechnology, which has 3 total studies on file at ClinicalTrials.gov.

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.

NCT06790966 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, Kentucky, California.

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.

What interventions are being tested in trial NCT06790966?

The interventions under investigation include: Pembrolizumab Monotherapy (DRUG), Combination Treatment of PDS0101 and Pembrolizumab (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT06790966?

This trial is sponsored by PDS Biotechnology, which has 3 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.