Phase 3 Study of PDS0101 and Pembrolizumab for HPV16+ Head and Neck Cancer

Sponsor: PDS Biotechnology Corp.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06790966

Provider View

This clinical trial is testing a new combination of treatments, PDS0101 and pembrolizumab, for patients with HPV16-positive head and neck cancer that has returned or spread. The study aims to see if this combination is more effective than pembrolizumab alone.

Patient Parameters

Program Overview

This global study is evaluating whether combining PDS0101, an immunotherapy, with pembrolizumab can improve survival in patients with HPV16-positive head and neck cancer that cannot be surgically removed and has returned or spread. The study will compare this combination to pembrolizumab alone, focusing on overall survival and other measures like response rate and disease control.

Description

PDS0101 is a treatment designed to activate the immune system to target HPV-specific cancer cells. In earlier studies, combining PDS0101 with pembrolizumab showed promising results in patients with HPV16-positive head and neck cancer. This study will compare the effects of this combination against pembrolizumab alone, looking at overall survival, response rates, and how long patients remain free of disease progression. Participants will be randomly assigned to receive either the combination treatment or pembrolizumab alone.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Must be 18 years or older.
  • Have a confirmed diagnosis of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in specific areas like the oropharynx or larynx.
  • Cancer must be HPV16-positive and express PD-L1 with a CPS score of 1 or higher.
  • No prior systemic cancer treatment for recurrent or metastatic cancer, unless it was completed over 6 months ago for locally advanced disease.
  • Have measurable disease based on specific criteria.
  • Must have adequate organ function, including specific blood counts and liver and kidney function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Men must agree to use a condom during the study and for 120 days after the last dose.
  • Must have a performance status indicating they are fully active or have some restrictions but can carry out light work.

Exclusion Criteria

  • Cancer located in the nasopharynx.
  • Positive pregnancy test.
  • Previous treatment with HPV-specific immunotherapy or certain other cancer therapies.
  • Major surgery within 30 days before starting the study.
  • Recent radiotherapy that does not meet specific recovery periods.
  • Recent live vaccine within 30 days before starting the study.
  • Use of certain immune-modulating drugs within 30 days before starting the study.
  • Participation in another clinical trial within 30 days before starting the study.
  • Previous stem cell transplant within the last 5 years.
  • Current immunodeficiency or use of high-dose steroids.
  • Another active cancer requiring treatment within the past 3 years.
  • Active brain metastases or certain autoimmune diseases.
  • Active infections requiring treatment.
  • HIV with low CD4 count or recent AIDS-defining infection.
  • Active hepatitis B or C infection.
  • Any condition that might interfere with the study or is not in the patient's best interest.
  • Psychiatric or substance abuse disorders affecting study participation.
  • Breastfeeding during the study period.
  • Previous organ transplant.
  • Women of childbearing potential not using effective contraception.
  • Allergic reactions to pembrolizumab or PDS0101.

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