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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05232851
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101 — BIOLOGICAL
    Given SC
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT, FDG-PET/CT
  • FDG-Positron Emission Tomography — PROCEDURE
    Undergo FDG-PET/CT
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Biopsy — PROCEDURE
    Undergo biopsy

Study Details

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.

Key Dates

Start date
Jun 16, 2022
Status verified
Mar 2026
Primary completion
Apr 9, 2025
Completion
Sep 10, 2026

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (PDS0101)
    Patients receive PDS0101 SC on day 1 of each cycle. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or FDG-PET/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.
  • Experimental: Arm B (PDS0101, pembrolizumab)
    Patients receive PDS0101 SC on day 1 and pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or FDG-PET/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.

Primary Outcome Measure

Proportion of Pathologic and Human Papillomavirus Cell-free Tumor Deoxyribonucleic Acid (ctHPVDNA) Response [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

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