Phase II Trial of Immunotherapeutic HPV Vaccine PRGN-2009 With Pembrolizumab Before Standard Treatment in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal Cancer

Conditions

• Oropharyngeal Squamous Cell Carcinoma (SCC)

Eligibility Criteria

Sex

ALL

Age

18 Years - 120 Years

Healthy Volunteers

Not accepted

Interventions

• PRGN-2009 — BIOLOGICAL
  PRGN-2009 5x10\^11 viral particles (VP) subcutaneously (SC) approximately two weeks apart
• Pembrolizumab — DRUG
  Pembrolizumab 200 mg intravenously (IV) concurrently with the first vaccine dose
• EKG — DIAGNOSTIC_TEST
  Baseline, completion visit, and safety follow-up visit.
• CT — DIAGNOSTIC_TEST
  Screening and baseline (neck and chest), and completion visit (neck).
• PET scan — DIAGNOSTIC_TEST
  Screening and baseline (neck and chest).
• MRI — DIAGNOSTIC_TEST
  Screening and baseline (neck and chest), and completion visit (neck).
• Biopsy — PROCEDURE
  Baseline and completion visit.

Study Details

Background: Cancers in and around the mouth associated with human papilloma virus (HPV) are common. Two treatments (the drug pembrolizumab and the HPV vaccine PRGN-2009) have been shown to work well when used individually against these cancers. Researchers want to find out if they might work better when used together. Objective: To test pembrolizumab combined with PRGN-2009 in people with HPV-positive cancers in and around the mouth. Eligibility: Adults aged 18 and older newly diagnosed with HPV-positive cancers in and around the mouth. Design: Participants will be screened. They will have a physical exam with blood tests. They will have imaging scans. They may need to have a biopsy: A sample of tissue will be taken from the tumor. PRGN-2009 is given as an injection under the skin. Pembrolizumab is given through a tube attached to a needle inserted into a vein in the arm. Participants will have at least 3 clinic visits: At the first, they will receive both the drug and the vaccine; 15 days later, they will receive a second shot of the vaccine. At the third visit, about 1 week after the second, they will have follow-up tests. During these visits, participants will give samples of blood, urine, and saliva. Imaging scans and biopsies will be repeated. They will have tests of their heart function. Participants may opt to return for another follow-up visit about 1 month after their second dose of the vaccine. Participants will have follow-up contacts by phone 3 and 6 months after starting the study. The calls will continue once a year for 5 years.

Key Dates

Start date

Nov 7, 2023

Status verified

Jun 2026

Primary completion

May 22, 2025

Completion

Jul 16, 2030

Study Design

Enrollment

26 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1/PRGN 5x10^11 Viral Particles Subcutaneously Plus Pembrolizumab 200mg Intravenous
  PRGN 5x10\^11 Viral Particles (VP) subcutaneous (SC) plus pembrolizumab 200mg intravenous (IV) as induction/ neoadjuvant therapy

Primary Outcome Measure

Percentage of Participants That Had a 2-fold Increase of Cluster of Differentiation 3 (CD3+) Tumor Infiltrating T Cells in Biopsies Performed Post-treatment Compared to Pre-treatment. [ Time Frame: Pre-Treatment (Baseline) and anytime between Week 4-5 post treatment ]

Locations (1)

Related coverage on Hipa.ai

• Pembrolizumab + PRGN-2009 for HPV-Oropharyngeal Cancer: 93.8% T-cell Increase
  Pembrolizumab · Jun 23, 2026 · ClinicalTrials.gov

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