Study on pBI-11 and TA-HPV Vaccines with Pembrolizumab for Advanced HPV-Positive Oropharyngeal Cancer
Sponsor: Michael K. Gibson
ClinicalTrials ID:NCT05799144
This clinical trial is exploring a new treatment combining pBI-11 and TA-HPV vaccines with pembrolizumab to see if it can help treat advanced oropharyngeal cancer that is positive for HPV and PD-L1. The study aims to determine if this combination can enhance the immune system's ability to fight cancer.
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Program Overview
This study is testing a new treatment approach for oropharyngeal cancer, a type of cancer that affects the back of the throat, including the tonsils and base of the tongue. The treatment combines two vaccines, pBI-11 and TA-HPV, with an immunotherapy drug called pembrolizumab. These vaccines are designed to boost the immune system's response against cancer cells that are positive for HPV, a virus linked to oropharyngeal cancer. Pembrolizumab is a drug that helps the immune system attack cancer cells. The study will evaluate if this combination can improve treatment outcomes for patients whose cancer has returned or spread.
Description
The main goal of this study is to see if the combination of pBI-11 and TA-HPV vaccines with pembrolizumab is safe and feasible for patients with advanced oropharyngeal cancer that is positive for HPV and PD-L1. Researchers will also assess how well this combination works as a first-line treatment for these patients.
Participants will receive the pBI-11 and TA-HPV vaccines through an injection into the muscle, and pembrolizumab will be given through an IV. The study will involve regular imaging tests like CT or MRI scans and blood sample collections to monitor the cancer's response to the treatment. Some patients may also have a tumor biopsy before and during the study to gather more information.
The study will also explore the overall survival and progression-free survival of patients receiving this treatment, as well as any changes in the immune response before and after treatment. Researchers will compare the immune response in patients who respond to pembrolizumab with those who do not.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a good performance status, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Must have advanced oropharyngeal cancer that is positive for HPV and PD-L1, and not previously treated for recurrent or metastatic disease.
- Must be eligible for pembrolizumab treatment.
- Must have measurable cancer that can be tracked using imaging tests.
- Must have adequate blood cell counts and organ function as determined by specific blood tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
- Must agree not to donate blood or sperm during the study and for a specified period after.
- Must be willing to sign an informed consent document and comply with study procedures.
Exclusion Criteria
- Cancer that can be treated with curative intent.
- Multiple primary oropharyngeal tumors or cancer not originating from the oropharynx.
- Previous treatment for recurrent or metastatic disease.
- Pregnant or breastfeeding women.
- Previous vaccination with any HPV antigen except certain vaccines like Gardasil or Cervarix.
- Recent receipt of a live vaccine.
- Participation in another clinical trial within four weeks prior to the study.
- Diagnosis of immunodeficiency or other active infections like HIV, hepatitis B, or C.
- History of severe allergic reactions to pembrolizumab.
- Significant heart disease or uncontrolled illnesses.
- Active autoimmune diseases or recent use of immunosuppressive drugs.
- Certain skin conditions or immunosuppressive conditions in close contacts.
- Severe heart rhythm issues or lung diseases.
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