RecruitingPhase 1NCT06589609
Phase 1 Clinical Trial of FluBHPVE6E7 Immunotherapy for HPV16-Associated Oropharyngeal Cancer
A Phase 1 Study of FluBHPVE6E7 Immunotherapy in Patients With HPV16- Associated Oropharyngeal Squamous Cell Carcinoma
Sponsor
BlueSky Immunotherapies GmbH
Enrollment
12 participants
Start Date
Aug 23, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
A clinical study of an immunotherapy in patients with head or neck cancers associated with the HPV16 virus
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria12
- 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 Criteria18
- 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
Interventions
BIOLOGICALFluBHPVE6E7
Intratumoral administration for first dose followed by intramuscular administration for subsequent doses at recommended dose level and determined schedule.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06589609