24 Participants Needed

PDS0101 Vaccine + Pembrolizumab for Oropharyngeal Cancer

CT
Overseen ByClinical Trials Referral Office
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

The PDS0101 vaccine has been shown to be safe in a phase I study, with participants experiencing only mild reactions at the injection site and demonstrating positive immune responses.12345

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?

DM

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

Platelet count >= 75,000/mm^3
Hemoglobin >= 9.0 g/dL
Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 X ULN
See 14 more

Exclusion Criteria

I haven't had a stroke, heart issues, blood clots, or taken immune system drugs recently.
I have not had any other cancer within the last 2 years.
I am currently using or have used immunosuppressive medication.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive PDS0101 alone or in combination with pembrolizumab every 21 days for up to 2 cycles

6 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

Up to 2 years
Every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101
  • Pembrolizumab
Trial Overview The trial is testing a vaccine called PDS0101 alone or combined with pembrolizumab, an immunotherapy drug. It aims to see if these treatments can shrink tumors before surgery in patients with HPV-related throat cancer. The study will assess how well the body's immune system responds to destroy tumor cells.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Arm B (PDS0101, pembrolizumab)Experimental Treatment6 Interventions
Patients receive PDS0101 SC on day 1 and pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or FDG-PET/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.
Group II: Arm A (PDS0101)Experimental Treatment5 Interventions
Patients receive PDS0101 SC on day 1 of each cycle. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or FDG-PET/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

HPV infections, particularly HPV genotype 16, contribute to over 11% of global cancer cases in females, highlighting the importance of effective vaccination strategies targeting HPV genes E6 and E7, as well as surface antigens L1 and L2.
Recent research shows promising developments in HPV vaccines, including the safe delivery of HPV 16 E7 peptide vaccinations to terminal patients and the potential for improved immune responses through innovative vaccine designs that enhance antigen presentation and induce both antibody and T cell responses.
Human papillomavirus genotype 16 vaccines for cervical cancer prophylaxis and treatment.Cornelison, TL.[2019]
Therapeutic vaccination targeting HPV-16 E6 and E7 oncogenes, combined with immune checkpoint modulation, showed promising results in a preclinical mouse model, leading to significant tumor regression in HPV+ squamous cell carcinomas of the oropharynx.
The combination of intranasal HPV peptide vaccination with 4-1BB and CTLA-4 antibodies not only eliminated most established tumors but also demonstrated a better safety profile, enhancing protective immunity by increasing CD8 T cells in the tumor environment.
Mucosal HPV E6/E7 Peptide Vaccination in Combination with Immune Checkpoint Modulation Induces Regression of HPV+ Oral Cancers.Dorta-Estremera, S., Chin, RL., Sierra, G., et al.[2020]
Pembrolizumab, an FDA-approved monoclonal antibody for recurrent or metastatic head and neck cancers, has shown limited efficacy, highlighting the need for alternative treatments.
Therapeutic vaccination is emerging as a promising strategy in head and neck cancers, with ongoing research into its potential synergistic effects when combined with anti-PD(L)1 therapies.
Vaccine-Based Immunotherapy for Head and Neck Cancers.Beyaert, S., Machiels, JP., Schmitz, S.[2021]

Citations

Human papillomavirus genotype 16 vaccines for cervical cancer prophylaxis and treatment. [2019]
Mucosal HPV E6/E7 Peptide Vaccination in Combination with Immune Checkpoint Modulation Induces Regression of HPV+ Oral Cancers. [2020]
Vaccine-Based Immunotherapy for Head and Neck Cancers. [2021]
Combination immunotherapy with synthetic long peptides and chemotherapy or PD-1 blocker for cancers caused by human papilloma virus type 16. [2023]
Safety and Efficacy of MEDI0457 plus Durvalumab in Patients with Human Papillomavirus-Associated Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma. [2023]
First-in-Human Phase I Clinical Trial of an SFV-Based RNA Replicon Cancer Vaccine against HPV-Induced Cancers. [2022]
ISA101 and nivolumab for HPV-16+ cancer: updated clinical efficacy and immune correlates of response. [2023]
Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine. [2021]
Phase Ib/II trial of tipapkinogene sovacivec, a therapeutic human papillomavirus16-vaccine, in combination with avelumab in patients with advanced human papillomavirus16-positive cancers. [2023]
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