Actively Recruiting
A Phase 1 Study of FluBHPVE6E7 Immunotherapy in Patients With HPV16- Associated Oropharyngeal Squamous Cell Carcinoma
Led by BlueSky Immunotherapies GmbH · Updated on 2024-09-19
12
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an immunotherapy called FluBHPVE6E7 in patients with oropharyngeal squamous cell carcinoma (OPSCC) linked to the HPV16 virus. This cancer type is increasingly common in younger people without traditional risk factors like smoking or alcohol. The study focuses on patients with HPV16-positive OPSCC who have locally advanced disease, aiming to understand the safety and immune response to this new treatment. The study uses FluBHPVE6E7, a biological agent that delivers HPV-16 oncogenes E6 and E7. The first dose is given directly into the tumor, followed by injections into the muscle at scheduled intervals. This is a phase 1 trial led by BlueSky Immunotherapies GmbH, focusing on safety and immune effects over several weeks, with long-term follow-up planned to assess disease-free and overall survival. Participants will undergo various assessments including monitoring for adverse events, immune cell infiltration in the tumor, virus presence in saliva and secretions, and blood tests over 24 weeks and beyond. The study tracks safety closely for 7 days initially and up to 60 months for survival outcomes. Participants will be followed regularly to evaluate immune responses and disease status during and after treatment.
CONDITIONS
Brief Title
Phase 1 Clinical Trial of FluBHPVE6E7 Immunotherapy for HPV16-Associated Oropharyngeal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male patients aged 18 to 65 years
- Newly diagnosed, histologically confirmed p16- and HPV16-positive oropharyngeal squamous cell carcinoma
- Locoregional advanced disease at stages T2N2-3, M0; T3N0-3, M0; or T4N0-3, M0
- Primary tumor accessible for biopsy and intratumoral administration
- No evidence of distant metastatic disease (HPV16-positive secondary tumors allowed)
- Karnofsky performance score between 70 and 100 (ECOG 0 or 1)
- Life expectancy of at least 6 months
- Normal or non-clinically significant ECG findings
- Negative pregnancy test for women of childbearing potential
- Agreement to use reliable contraception during study treatment
- Written informed consent provided
You will not qualify if you...
- Presence of distant metastases
- Secondary malignancy not associated with HPV16
- History of other malignancies unless in complete remission for at least 2 years without additional therapy
- Abnormal blood, kidney, or liver tests not explained by underlying disease
- Vaccination within 1 week before study start
- Active significant viral infections including influenza, CMV, or EBV within 4 weeks before treatment
- Co-infection with hepatitis B, hepatitis C, or HIV, or other immune deficiencies
- Influenza-like illness within 4 weeks before study start
- Known allergy to Tamiflu or its components
- Pregnancy or breastfeeding
- Serious concurrent disorders requiring treatment
- Autoimmune diseases such as lupus, thyroiditis, inflammatory bowel disease, or multiple sclerosis
- Immunosuppressive treatments including systemic steroids or certain biologic drugs
- Major surgery within 4 weeks before study start
- Significant cardiac, liver, or kidney disease or unstable medical conditions
- Participation in another experimental study or use of investigational drugs within 2 months
- Any condition that may prevent safe participation or compliance with the study protocol
- Inability to comply with protocol requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive FluBHPVE6E7 immunotherapy administered intratumorally for the first dose, followed by intramuscular doses at a recommended schedule.
Multiple visits for dosing and monitoring over 24 weeks
Duration - Up to 60 months
Participants are monitored for safety, immune response, and survival outcomes after treatment completion.
Periodic visits for assessments up to 5 years
Trial Site Locations
Total: 1 location
1
Medical University Vienna
Vienna, Austria, 1090
Actively Recruiting
Research Team
M
Medical University of Vienna
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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