Actively Recruiting
Phase 1 Clinical Trial of FluBHPVE6E7 Immunotherapy for HPV16-Associated Oropharyngeal Cancer
Led by BlueSky Immunotherapies GmbH · Updated on 2024-09-19
12
Participants Needed
1
Research Sites
270 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A clinical study of an immunotherapy in patients with head or neck cancers associated with the HPV16 virus
CONDITIONS
Official 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 18 to 65 years old
- 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 status between 70 and 100 (ECOG 0 or 1)
- Life expectancy of at least 6 months
- Normal or clinically non-significant screening ECG
- Negative serum pregnancy test for women of childbearing potential
- Agreement to use reliable contraception during the study treatment period
- Provides written informed consent
You will not qualify if you...
- Presence of distant metastases
- Secondary malignancy not associated with HPV16
- History of other malignancies unless complete remission for at least 2 years and no therapy needed
- Clinically significant abnormal blood, kidney, or liver tests unexplained by disease
- Vaccination within 1 week before day 0
- Active significant viral infections (influenza, CMV, EBV) within 4 weeks before treatment
- Co-infection with hepatitis B, hepatitis C, or HIV or other immune deficiency
- Influenza-like illness within 4 weeks before day 0
- Known allergy to Tamiflu or its components
- Pregnancy or breastfeeding
- Serious disorders including active systemic infections requiring treatment
- Autoimmune diseases such as lupus, thyroiditis, inflammatory bowel disease, or multiple sclerosis
- Immunosuppression or use of immunosuppressive drugs or biologics; corticosteroids stopped more than 4 weeks before treatment
- Major surgery within 4 weeks before day 0
- Significant cardiac, liver, or kidney disease or unstable medical conditions
- Participation in another experimental protocol or investigational drug use within 2 months before day 0
- Any condition preventing safe participation or study compliance
- Inability to comply with the protocol requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Medical University Vienna
Vienna, Austria, 1090
Actively Recruiting
Research Team
M
Medical University of Vienna
CONTACT
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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