Immunotherapy for HPV16-Related Oropharyngeal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of an immunotherapy called FluBHPVE6E7 in patients diagnosed with oropharyngeal squamous cell carcinoma associated with the HPV16 virus. The study focuses on patients with locoregionally advanced disease, where the treatment is administered both intratumorally and intramuscularly. The aim is to evaluate the safety and efficacy of this novel immunotherapeutic approach in a population that has seen a rising incidence of HPV-related cancers. Participants will be closely monitored for their response to the treatment and any potential side effects.

Why it matters

Who can join: the full rules

Inclusion criteria:

* Female or male patients, 18-65 years of age, with newly diagnosed, histologically confirmed p16- and HPV16-positive oropharyngeal squamous cell carcinoma with locoregional advanced disease including the following stages:

  * T2N2-3, M0
  * T3N0-3, M0
  * T4N0-3, M0
* Primary tumour accessible for biopsy and intratumoural administration
* No evidence of distant metastatic disease (HPV16-positive secondary tumours are permissible)
* Karnofsky 100 - 70 (ECOG 0 or 1)
* Life expectancy of at least 6 months
* Normal screening ECG or screening ECG with no clinically significant findings requiring immediate treatment, as judged by the investigator
* Women of childbearing potential: Negative serum pregnancy test at screening
* Agree to use a reliable form of contraception until the end of the study treatment period.
* Provides written informed consent

Exclusion criteria:

* Distant metastases
* Secondary, not HPV16-associated, malignancy
* History of malignancy other than the target malignancy to be investigated in this trial unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period
* Clinically significant out of range haematological, renal or hepatic laboratory tests which cannot be explained by the underlying disease
* Any vaccination within 1 week before day 0
* Active significant viral infections including influenza, CMV, and EBV within 4 weeks before receiving study treatment
* Co-infection with hepatitis B, hepatitis C, or HIV or having other immune deficient states
* Influenza-like illness (ILI) within 4 weeks before day 0
* Known hypersensitivity to Tamiflu or any of its components
* Pregnancy, breastfeeding
* Serious, concomitant disorder, including active systemic infection requiring treatment
* Proven or suspected systemic lupus erythematosus, thyroiditis, inflammatory bowel disease including Crohn's disease or multiple sclerosis
* Immunosuppression including any concurrent condition requiring the continued use of systemic steroids, or the use of immunosuppressive agents, disease modifying doses of anti-rheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate), and biologic disease modifying drugs such as TNF-α inhibitors (e.g. infliximab, adalimumab or etanercept). Corticosteroids must be discontinued \> 4 weeks prior to day 0 of study medication administration. Eye drops or ear drops containing corticosteroids are permissible.
* Prior major surgery within 4 weeks before day 0
* Any current significant cardiac, hepatic or renal disease or history of clinically significant, medically unstable disease (e.g. chronic renal failure; angina, myocardial ischemia or infarction, congestive heart failure, cardiomyopathy, or clinically significant arrhythmias)
* Participation in another experimental protocol/use of investigational drug within two months before day 0
* Any condition that, in the judgment of the investigator, might prevent safe participation in the study or interfere with study objectives
* Unability to comply with the protocol requirements

Where it's running

• Medical University Vienna
  Vienna, Austria Recruiting

Study contacts

• Study coordinator: Medical University of Vienna
• Email: klin-pharmakologie@meduniwien.ac.at
• Phone: +43140400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.