HPV-16 Vaccine and Pembrolizumab with Cisplatin for Intermediate Risk HPV-16-related Head and Neck Cancer

Sponsor: Dan Zandberg

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04369937

Provider View

This study is testing a new treatment combination for patients with a specific type of head and neck cancer linked to HPV-16. It includes a vaccine, an immunotherapy drug, and chemotherapy with radiation.

Patient Parameters

Program Overview

This clinical trial is exploring a new treatment approach for patients with a type of head and neck cancer associated with HPV-16. The treatment combines a vaccine targeting HPV, an immunotherapy drug called pembrolizumab, and chemotherapy with radiation. The goal is to see if this combination can improve survival in patients with newly diagnosed, locally advanced cancer that is considered intermediate risk.

Description

The study is for adults with a specific type of head and neck cancer that hasn't spread to distant parts of the body. All participants will receive the same treatment, which includes a vaccine targeting HPV, chemotherapy, and an immunotherapy drug.

Patients will first have a biopsy, then start the HPV vaccine treatment two weeks before chemotherapy and radiation, and one week before the first dose of pembrolizumab. The vaccine will be given three times in total. Pembrolizumab will be started one week before chemotherapy and radiation and will continue for 24 weeks in total. The study aims to see how well patients survive with this treatment combination.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with head and neck squamous cell carcinoma, with no spread to distant areas, and the primary site being the oropharynx.
  • Must have intermediate risk disease, meeting specific criteria related to tobacco exposure and cancer stage.
  • Not a candidate for surgery aimed at curing the cancer.
  • Must have measurable disease and be in good overall health (ECOG status 0-1).
  • Age 18 or older.
  • Must provide a tumor sample and undergo a mandatory biopsy.
  • Must have adequate organ function and not be pregnant.
  • Must provide written informed consent.

Exclusion Criteria

  • Cancer in the oral cavity, larynx, hypopharynx, or nasopharynx.
  • Participation in another study with an investigational drug within 4 weeks.
  • Previous treatment with anti-HPV agents, except preventive vaccines.
  • Severe allergies to study drugs.
  • Cancer that has spread to distant areas, including the brain.
  • Active autoimmune diseases or infections like hepatitis B or C.
  • Previous treatment with certain immunotherapy drugs.
  • Significant lung, heart, or other medical conditions.
  • Recent major surgery or active infections.
  • Pregnant or breastfeeding women.

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