Phase 1 Clinical Trial of FluBHPVE6E7 Immunotherapy for HPV16-Associated Oropharyngeal Cancer

Trial Title: Phase 1 Clinical Trial of FluBHPVE6E7 Immunotherapy for HPV16-Associated Oropharyngeal Cancer

NCT ID: NCT06589609

Condition: Oropharyngeal Squamous Cell Carcinoma (SCC)

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck

Conditions: Keywords:
immunotherapy
Oropharyngal squamous cell carcinoma
HPV-16
Human papilloma virus
cancer
Head and neck cancer

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: FluBHPVE6E7
Description: Intratumoral administration for first dose followed by intramuscular administration for subsequent doses at recommended dose level and determined schedule.
Arm group label: Intervention

Summary: A clinical study of an immunotherapy in patients with head or neck cancers associated with the HPV16 virus

Detailed description: Squamous cell carcinomas of the head and neck (HNSCC) rank as the sixth most common cancer globally, with approximately 575,000 new cases diagnosed each year. In recent years, there has been a rising incidence in younger patients who have limited exposure to traditional risk factors such as smoking and alcohol. This increase is closely associated with HPV infection, particularly HPV-16, which is strongly linked to oropharyngeal cancer. Treatment for HPV-positive oropharyngeal squamous cell carcinoma (OPSCC) is highly individualized, depending on the disease stage, patient comorbidities, and personal preferences. In this phase 1 study, patients with HPV-16-associated OPSCC are being treated with the immunotherapeutic delNS-vector expressing the HPV-16 oncogenes E6 and E7, administered both intratumorally and intramuscularly.

Criteria for eligibility:
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

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: Medical University Vienna

Address:
City: Vienna
Zip: 1090
Country: Austria

Status: Recruiting

Contact:
Last name: Department of Clinical Pharmacology

Phone: +43140400

Phone ext: 29800
Email: klin-pharmakologie@meduniwien.ac.at

Start date: August 23, 2024

Completion date: November 2029

Lead sponsor:
Agency: BlueSky Immunotherapies GmbH
Agency class: Industry

Source: BlueSky Immunotherapies GmbH

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06589609