Tests an immunotherapy vaccine in adults with HPV16-linked throat cancer

Trial details

Who runs it

BlueSky Immunotherapies GmbH

Trial code

NCT06589609EU 2024-514413-36-00

Record updated

19 September 2024

Original description

A clinical study of an immunotherapy in patients with head or neck cancers associated with the HPV16 virusRead full original descriptionShow less

A Phase 1 Study of FluBHPVE6E7 Immunotherapy in Patients With HPV16- Associated Oropharyngeal Squamous Cell Carcinoma

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

Inclusion: 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: Any vaccination within 1 week before day 0; Active significant viral infections including influenza, CMV, and EBV within 4 weeks before receiving study treatment; Influenza-like illness (ILI) within 4 weeks before day 0; Serious, concomitant disorder, including active systemic infection requiring treatment; 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; Participation in another experimental protocol/use of investigational drug within two months before day 0; 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; Co-infection with hepatitis B, hepatitis C, or HIV or having other immune deficient states; Known hypersensitivity to Tamiflu or any of its components; Proven or suspected systemic lupus erythematosus, thyroiditis, inflammatory bowel disease including Crohn's disease or multiple sclerosis; 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); Any condition that, in the judgment of the investigator, might prevent safe participation in the study or interfere with study objectives; Clinically significant out of range haematological, renal or hepatic laboratory tests which cannot be explained by the underlying disease; Distant metastases; Pregnancy, breastfeeding; Unability to comply with the protocol requirements.

ClinicalTrials.gov NCT06589609 · EU CTIS 2024-514413-36-00