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

StatusActive, Not Recruiting
PhasePhase 1/2
Started

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Record History

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  1. Study completion pushed from Sep 10, 2026 to Jan 10, 2027
    • Interventions: Biopsy (Procedure), Biospecimen Collection (Procedure), Computed Tomography (Procedure), FDG-Positron Emission Tomography (Procedure)… to Biopsy (Procedure), Biospecimen Collection (Procedure), Computed Tomography (Procedure), FDG-Positron Emission Tomography (Procedure)…
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: details revised at 3 of 4 entries
  2. Results first posted: Apr 14, 2026v12 Show 4 more changesShow less
    • Study completion pushed from Apr 9, 2025 to Sep 10, 2026
    • Trial status: Completed to Active, Not Recruiting
    • Secondary endpoints revised (4)
    • Primary endpoint revised
  3. Trial status: Active, Not Recruiting to Completed
    • Primary and study completion dates changed from estimate of Oct 1, 2026 to Apr 9, 2025
    v11
  4. Enrollment target: estimated 24 to confirmed 20v10
  5. Primary and study completion dates: Jul 1, 2025 to Oct 1, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary and study completion dates: Jul 1, 2024 to Jul 1, 2025
    • Start date: Feb 22, 2022 to Jun 16, 2022
    v8
  2. Eligibility criteria shortened, about 1 wordv7
  3. Interventions: Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101 (Biological), Pembrolizumab (Biological) to Biopsy (Procedure), Biospecimen Collection (Procedure), Computed Tomography (Procedure), FDG-Positron Emission Tomography (Procedure)…
    • Secondary endpoints: details revised at 2 of 4 entries
    • Study description expanded, about 55 words
    • Eligibility criteria expanded, about 4 words
    v6
  4. Primary completion date: Jul 1, 2023 to Jul 1, 2024v5
  5. Start date: Mar 7, 2022 to Feb 22, 2022
    • Eligibility criteria expanded, about 2 words
    v4
  6. Collaborators shortened, about 4 wordsv3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 11, 2022 to Mar 7, 2022
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Mayo Clinic
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Head & Neck Cancer
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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.
Trial Details
NCT Number NCT05232851
Lead Sponsor Mayo Clinic
Conditions
(from sponsor)		 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
Related terms Carcinoma, Oropharyngeal Neoplasms
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov