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A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer

NCT05232851 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-14

Study results available
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Summary

This phase I/II trial studies how well PDS0101 alone or in combination with pembrolizumab works to shrink tumor in patients with human papillomavirus-associated oropharynx cancer that has spread to nearby tissue or lymph nodes (locally advanced). PDS0101 is a vaccine made from specific peptides that may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving PDS0101 with or without pembrolizumab may kill more tumor cells in patients with locally advanced human papillomavirus-associated oropharynx cancer before surgery so that it may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.

Conditions

  • Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • Human Papillomavirus-Related Carcinoma
  • Locally Advanced Oropharyngeal Carcinoma
  • Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
  • Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Interventions

BIOLOGICAL

Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101

Given SC

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Computed Tomography

Undergo CT, FDG-PET/CT

PROCEDURE

FDG-Positron Emission Tomography

Undergo FDG-PET/CT

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Biopsy

Undergo biopsy

Sponsors & Collaborators

Principal Investigators

  • David M. Routman, M.D. · Mayo Clinic in Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-16
Primary Completion
2025-04-09
Completion
2026-09-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Companies

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 NCT05232851 on ClinicalTrials.gov