PDS0101 Vaccine + Pembrolizumab for Oropharyngeal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive medication, you must stop at least 14 days before joining the trial, unless it's a low-dose steroid or certain other exceptions.
Is the PDS0101 vaccine safe for humans?
What makes the PDS0101 Vaccine + Pembrolizumab treatment unique for oropharyngeal cancer?
The PDS0101 Vaccine + Pembrolizumab treatment is unique because it combines a vaccine targeting HPV-16 proteins with an immune checkpoint inhibitor, which helps the immune system recognize and attack cancer cells more effectively. This combination aims to enhance the body's immune response against HPV-related oropharyngeal cancer, potentially improving outcomes compared to standard treatments.24678
What data supports the effectiveness of the PDS0101 Vaccine + Pembrolizumab treatment for oropharyngeal cancer?
Research shows that combining HPV-targeted vaccines with immune checkpoint inhibitors like pembrolizumab can enhance the immune response against HPV-related cancers, leading to tumor regression in preclinical models. Additionally, similar combination treatments have shown promising results in clinical trials for HPV-positive head and neck cancers, improving survival rates and response rates.34679
Who Is on the Research Team?
David M. Routman, M.D.
Principal Investigator
Mayo Clinic in Rochester
Are You a Good Fit for This Trial?
Adults over 18 with locally advanced HPV-associated oropharynx cancer, who have not received certain treatments recently and do not have active autoimmune diseases, other cancers within the last 2 years (with some exceptions), or uncontrolled illnesses. Participants must be able to undergo surgery and agree to use contraception if applicable.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive PDS0101 alone or in combination with pembrolizumab every 21 days for up to 2 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
National Cancer Institute (NCI)
Collaborator