Clinical Trials

Inclusion Criteria: 

• Age ≥18 years.
• Clinically confirmed diagnosis of recurrent respiratory papillomatosis. Patients with papillomas in the laryngeal mucosa at the time of recruitment and patients with records of recurrent papillomas in laryngeal mucosa at least once in the past 6-12 months at the time of recruitment. NOTE: The presence of papillomas in laryngeal mucosa or clinical records of the presence of papillomas in laryngeal mucosa is required.
• Human papilloma virus (HPV)6+ RRP in larynx.
• ECOG (Eastern cooperative oncology group performance test) performance status 0 or 1 (Appendix I).
• The following laboratory values obtained ≤ 28 days prior to registration.
  • Absolute neutrophil count (ANC) ≥ 1.0 x 109 /L
  • Platelet count (PLT) ≥ 75 x 109 /L
  • Hemoglobin ≥ 8.5 g/dL
  • Lymphocytes ≥ 0.3 x 109 /L
  • Total bilirubin ≤ 2 x upper limit of normal (ULN), unless patient has a documented history of Gilbert’s disease, then Direct bilirubin ≤1.0 mg/dL.
  • Aspartate transaminase (AST) ≤ 3 x ULN
  • Creatinine ≤ 2.0 mg/dL
  • Monocytes ≥ 0.25 x 109 /L
• Able to provide informed written consent.
• Willingness to return to Mayo Clinic Arizona for follow-up appointments.
• Willingness to provide blood samples for immune assessment and other tests.
• Willingness to provide papilloma tissues that will be surgically removed.

Exclusion Criteria: 

• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
• Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Receiving any other approved or investigational agent (including immune checkpoint blockers, immune modulators, and therapeutic vaccine models) for recurrent respiratory papillomatosis patients which would be considered as a treatment for the papillomas in laryngeal mucosa.
• Other active malignancy ≤ 3 years prior to registration. NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer.
• History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
• Immunosuppressive therapy (excluding topical steroids) for any other condition ≤ 4 weeks prior to registration.
• Persistent fever (> 24 hours) documented by repeated measurement ≤ 4 weeks prior to registration 9. Diagnosis of autoimmune disease, including, but not limited to, systemic lupus erythematosus, multiple sclerosis, rheumatoid arthritis, or ankylosing spondylitis.
• Use of a systemic steroid (> 5 mg prednisone daily or equivalent) ≤ 4 weeks prior to registration.
• Pregnancy. Persons of childbearing potential must have a urine pregnancy test prior to each injection.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/6/2025. Questions regarding updates should be directed to the study team contact.