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

NCT06790966 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2026-04-06

No results posted yet for this study

Summary

This is a global, multi-center, Phase 3 study that is randomized 1:1, 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

  • Recurrent Head and Neck Cancer
  • Metastatic Head and Neck Cancer
  • HPV Positive Oropharyngeal Squamous Cell Carcinoma
  • Neoplasms, Head and Neck
  • Unresectable Head and Neck Squamous Cell Carcinoma

Interventions

COMBINATION_PRODUCT

Combination Treatment of PDS0101 and Pembrolizumab

* Pembrolizumab (IV) every 3 weeks for up to 35 Cycles * PDS0101 (SC) during Cycles 1, 2, 3, 4, and 12

DRUG

Pembrolizumab Monotherapy

Pembrolizumab (IV) every 3 weeks for up to 35 cycles.

Sponsors & Collaborators

  • PDS Biotechnology Corp.

    lead INDUSTRY

Principal Investigators

  • Kirk V Shepard, MD · PDS Biotechnology Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-30
Primary Completion
2029-02-28
Completion
2029-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06790966 on ClinicalTrials.gov