Immunotherapy for HPV16-Related Oropharyngeal Cancer
A Phase 1 Study of FluBHPVE6E7 Immunotherapy in Patients With HPV16- Associated Oropharyngeal Squamous Cell Carcinoma
This study is testing a new immunotherapy treatment for patients with HPV16-related throat cancer to see if it is safe and effective.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | BlueSky Immunotherapies GmbH Industry-sponsored |
| Drugs / interventions | infliximab, adalimumab, methotrexate, cyclophosphamide, immunotherapy |
| Locations | 1 site (Vienna) |
| Trial ID | NCT06589609 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with newly diagnosed, histologically confirmed HPV16-positive oropharyngeal squamous cell carcinoma at advanced locoregional stages.
Not a fit: Patients with distant metastatic disease or those with secondary malignancies not associated with HPV16 may not benefit from this study.
Why it matters
Potential benefit: If successful, this immunotherapy could provide a new treatment option for patients with HPV16-associated oropharyngeal cancer, potentially improving survival rates and quality of life.
How similar studies have performed: While this approach is novel, other studies have explored immunotherapy for HPV-related cancers, showing promising results in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Vienna
- Medical University Vienna — Vienna, Austria (Recruiting)
Study contacts
- Study coordinator: Medical University of Vienna
- Email: klin-pharmakologie@meduniwien.ac.at
- Phone: +43140400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.