Phase II Study of HPV Vaccine PRGN-2009 and Pembrolizumab Before Standard Treatment for Newly Diagnosed HPV-Related Mouth and Throat Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05996523

Provider View

This clinical trial is testing whether combining the HPV vaccine PRGN-2009 with the drug pembrolizumab before standard treatment can improve outcomes for adults newly diagnosed with HPV-positive cancers in the mouth and throat area.

Patient Parameters

Program Overview

This study is exploring a new approach to treating HPV-related cancers in the mouth and throat by combining two treatments: the HPV vaccine PRGN-2009 and the drug pembrolizumab. Both treatments have shown promise individually, and researchers want to see if using them together before standard treatment can enhance their effectiveness. Participants will receive these treatments and undergo various tests to monitor their health and the treatment's impact.

Description

Human papilloma virus (HPV) is linked to certain types of mouth and throat cancers, which are becoming more common. While early-stage cancers have a good outlook, more advanced stages can be life-threatening. The usual treatment involves chemotherapy and radiation or surgery. This study is testing a new approach by using an HPV vaccine (PRGN-2009) and a drug called pembrolizumab before the standard treatment to boost the immune system's response to the cancer.

The study aims to see if this combination can increase the number of immune cells attacking the cancer. Participants will receive two doses of the vaccine and one dose of pembrolizumab before their main treatment. The study will enroll up to 20 participants who meet specific criteria.

Participants will have several clinic visits for treatment and follow-up tests, including blood, urine, and saliva samples, imaging scans, and heart function tests. They may also have biopsies to check the cancer's response. Follow-up will continue by phone for up to five years to monitor long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with newly diagnosed stage I, II, or III HPV-positive mouth or throat cancer.
  • Cancer must be measurable by standard criteria.
  • Good overall health with a performance status of 0 to 2, meaning fully active or able to do light work.
  • Adequate blood cell counts and organ function based on specific tests.
  • HIV, Hepatitis B, or C positive individuals can participate if their viral loads are undetectable and they meet other health criteria.
  • Women of childbearing potential must use effective birth control during the study and for four months after the last dose of pembrolizumab.
  • Willingness to undergo two research biopsies.
  • Ability to understand and sign informed consent.

Exclusion Criteria

  • Recent use of investigational drugs, live vaccines, chemotherapy, or immunotherapy within four weeks before starting the study.
  • Major surgery within 28 days before starting the study.
  • Pregnant individuals.
  • Active autoimmune diseases that could worsen with the study treatment, except for certain mild conditions.
  • Use of systemic steroids or immunosuppressive drugs, except for low doses or specific uses.
  • History of other cancers that could interfere with the study.
  • Previous organ transplants.
  • Low oxygen levels in the blood.
  • Other uncontrolled illnesses that could affect participation.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.