Study on Vaccine PDS0101 Alone or with Pembrolizumab for Treating Locally Advanced HPV-Associated Oropharynx Cancer

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05232851

Provider View

This clinical trial is testing a vaccine called PDS0101, alone or with the drug pembrolizumab, to see if it can shrink tumors in patients with locally advanced oropharynx cancer linked to HPV. The study aims to find out if these treatments can make tumors smaller before surgery, potentially reducing the amount of normal tissue that needs to be removed.

Patient Parameters

Program Overview

This study is exploring whether a vaccine called PDS0101, used alone or with the drug pembrolizumab, can help shrink tumors in patients with oropharynx cancer associated with human papillomavirus (HPV) that has spread to nearby tissues or lymph nodes. PDS0101 is designed to help the immune system target and kill cancer cells. Pembrolizumab is an immunotherapy drug that may help the immune system attack cancer and stop tumor growth. The goal is to see if these treatments can reduce tumor size before surgery, possibly allowing for less normal tissue to be removed.

Description

The main goal of this study is to see how well the vaccine PDS0101, alone or with pembrolizumab, works in patients with high-risk HPV-associated oropharynx cancer. Researchers will look at how the cancer responds to these treatments and measure the levels of HPV-related DNA in the blood.

Secondary goals include evaluating how much the tumors shrink, how long patients live without the cancer getting worse, and overall survival rates.

Safety is also a key focus, as researchers will monitor any side effects from the treatments.

The study will also explore changes in the tumor environment and the immune response to the treatments.

Participants will be randomly assigned to one of two groups:

  • Group A: Receive PDS0101 vaccine under the skin every 21 days for up to 2 cycles, along with regular scans and blood tests. A biopsy may be done during the study.
  • Group B: Receive PDS0101 vaccine and pembrolizumab through an IV every 21 days for up to 2 cycles, along with regular scans and blood tests. A biopsy may be done during the study.

After completing the treatment, patients will have follow-up visits every 3 months for up to 2 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have locally advanced HPV-associated oropharynx cancer with specific high-risk features.
  • Be a candidate for surgery or chemo-radiation with the intent to cure.
  • Have measurable or unmeasurable disease as per specific criteria.
  • Be in good overall health with a performance status of 0 or 1.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 120 days after the last dose.
  • Must provide written informed consent and be willing to return for follow-up visits.
  • Agree to provide blood and tissue samples for research purposes.

Exclusion Criteria

  • Have an active autoimmune disease requiring treatment or a history of severe autoimmune disease.
  • Have received prior head or neck cancer treatments like chemotherapy, radiotherapy, or immunotherapy.
  • Have received a live vaccine within 30 days before starting the study.
  • Have used immunosuppressive medication within 14 days before starting the study, with some exceptions.
  • Have uncontrolled illnesses, such as active infections, lung disease, or heart conditions.
  • Have a history of organ transplants or other active cancers within the last 2 years, with some exceptions.
  • Have had certain medical events like a stroke or heart surgery within 6 weeks before starting the study.
  • Be receiving other investigational treatments or have received certain therapies within a specified time before the study.

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